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Role of Propolis Paste in Preventing Pain After Root Canal Treatment.

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ClinicalTrials.gov Identifier: NCT03723980
Recruitment Status : Completed
First Posted : October 30, 2018
Results First Posted : June 6, 2019
Last Update Posted : June 6, 2019
Sponsor:
Collaborator:
Dow University of Health Sciences
Information provided by (Responsible Party):
Juzer Shabbir Saifee, Dow University of Health Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Pain, Postoperative
Interventions Drug: Propolis
Drug: Calcium Hydroxide
Enrollment 80
Recruitment Details

Start of recruitment : 1st october 2017 End of Recruitment: 24th april 2018

location: Pakistan; Karachi; Dow-International dental college, Operative Dentistry; out-patient department.

Pre-assignment Details  
Arm/Group Title Control Group or Group I or Calcium Hydroxide Group Experimental Group or Group II or Propolis Group
Hide Arm/Group Description Calcium Hydroxide: it is a synthetic antimicrobial intracanal medicament and gold standard to which other medicaments are being compared. approximately 150 mg of calcium hydroxide paste will be inserted in the root canal. it will be inserted only once and will remain in root canals for 4 days. Propolis: it is a natural product obtained from beehive. it has been evaluated for biocompatibility and toxicity; and it is found that it is extremely biocompatible material. In our study, propolis powder will be mixed with saline in a ratio of 1 : 1.5 (propolis powder(wt) / saline(vol)) to form paste; and inserted into the root canals. it will be inserted once and will remain in root canals for 4 days.
Period Title: Overall Study
Started 40 40
Completed 33 35
Not Completed 7 5
Arm/Group Title Control Group or Group I or Calcium Hydroxide Group Experimental Group or Group II or Propolis Group Total
Hide Arm/Group Description Calcium Hydroxide: it is a synthetic antimicrobial intracanal medicament and gold standard to which other medicaments are being compared. approximately 150 mg of calcium hydroxide paste will be inserted in the root canal. it will be inserted only once and will remain in root canals for 4 days. Propolis: it is a natural product obtained from beehive. it has been evaluated for biocompatibility and toxicity; and it is found that it is extremely biocompatible material. In our study, propolis powder will be mixed with saline in a ratio of 1 : 1.5 (propolis powder(wt) / saline(vol)) to form paste; and inserted into the root canals. it will be inserted once and will remain in root canals for 4 days. Total of all reporting groups
Overall Number of Baseline Participants 40 40 80
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 40 participants 80 participants
33.6  (6.3) 33.2  (6) 33.4  (6.1)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Age Range Number Analyzed 40 participants 40 participants 80 participants
20 to 24
4
  10.0%
4
  10.0%
8
  10.0%
25 to 29
7
  17.5%
4
  10.0%
11
  13.8%
30 to 34
6
  15.0%
13
  32.5%
19
  23.8%
35 to 40
23
  57.5%
19
  47.5%
42
  52.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 participants
Female
28
  70.0%
22
  55.0%
50
  62.5%
Male
12
  30.0%
18
  45.0%
30
  37.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
40
 100.0%
40
 100.0%
80
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Number of participants
Pakistan Number Analyzed 40 participants 40 participants 80 participants
40 40 80
Pre-operative pain score from 0 (no pain) to 100 (worst pain) on Visual Analogue Scale  
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 40 participants 40 participants 80 participants
13.1  (17.4) 18.1  (12.4) 15.6  (17.5)
Type of single-rooted teeth  
Measure Type: Number
Unit of measure:  Number of teeth
Number Analyzed 40 participants 40 participants 80 participants
Maxillary Central Incisor 4 2 6
Maxillary Lateral Incisor 4 4 8
Maxillary Canine 8 7 15
Maxillary Second Premolar 6 14 20
Mandibular Lateral Incisor 3 0 3
Mandibular Canine 1 2 3
Mandibular First Premolar 4 5 9
Mandibular Second Premolar 10 6 16
1.Primary Outcome
Title Pain Intensity Measure: Visual Analogue Pain Scale
Hide Description

Self recorded pain intensity by the patients at 4 hours, 12 hours, day 2, day 3 and day 4 after root canal preparation and intracanal medicament insertion (first visit). Pain intensity recorded on a Visual Analogue Scale from 0 to 100. Patients who experience no or mild pain; and do not require analgesic will record their pain intensity from 0 to 24. Patients who experience moderate pain; and require Over-the-counter analgesic will record pain intensity from 25 to 49. Patients who experience severe pain; and require use of codeine containing medicine will record their pain intensity from 50 to 74. Patients who experience extreme pain, and no medicine is able to relieve their pain will record pain intensity from 75 to 100.

lower pain score (intensity) is a better outcome as compared to higher pain intensity (score)

Time Frame 4 hours, 12 hours, day 2, day 3 and day 4
Hide Outcome Measure Data
Hide Analysis Population Description
Out of 80 patients, 12 did not return for follow-up; and no contact could be established with them. Out of these 12 patients, 7 belong to control group and 5 belong to experimental group. Hence, 33 patients in control group and 35 patients in experimental group could be analyzed
Arm/Group Title Control Group or Group I or Calcium Hydroxide Group Experimental Group or Group II or Propolis Group
Hide Arm/Group Description:
Calcium Hydroxide: it is a synthetic antimicrobial intracanal medicament and gold standard to which other medicaments are being compared. approximately 150 mg of calcium hydroxide paste will be inserted in the root canal. it will be inserted only once and will remain in root canals for 4 days.
Propolis: it is a natural product obtained from beehive. it has been evaluated for biocompatibility and toxicity; and it is found that it is extremely biocompatible material. In our study, propolis powder will be mixed with saline in a ratio of 1 : 1.5 (propolis powder(wt) / saline(vol)) to form paste; and inserted into the root canals. it will be inserted once and will remain in root canals for 4 days.
Overall Number of Participants Analyzed 33 35
Mean (Standard Deviation)
Unit of Measure: score on a scale
4 hours 11.8  (18.7) 8.8  (11.1)
12 hours 9.4  (16.7) 10.3  (13.3)
Day 2 3.5  (7.7) 5.1  (9.2)
Day 3 2.6  (6.4) 3.4  (6.8)
Day 4 1.9  (4.7) 2.7  (7.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group or Group I or Calcium Hydroxide Group, Experimental Group or Group II or Propolis Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.329
Comments

the calculated p value is for time interval of 4 hours

threshold for statistical significance= <0.05

Method ANOVA
Comments For multiple comparisons between groups, post hoc (LSD) was applied
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.96
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control Group or Group I or Calcium Hydroxide Group, Experimental Group or Group II or Propolis Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.764
Comments

The calculated p value is for time interval of 12 hours

threshold for statistical significance= <0.05

Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.92
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Control Group or Group I or Calcium Hydroxide Group, Experimental Group or Group II or Propolis Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.605
Comments

The calculated p value is for time interval of day 2

threshold for statistical significance= <0.05

Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.57
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Control Group or Group I or Calcium Hydroxide Group, Experimental Group or Group II or Propolis Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.786
Comments

The calculated p value is for time interval of day 3

threshold for statistical significance= <0.05

Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.82
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Control Group or Group I or Calcium Hydroxide Group, Experimental Group or Group II or Propolis Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.813
Comments

The calculated p value is for time interval of day 4

threshold for statistical significance= <0.05

Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.72
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Acute Increase in Pain Score (Acute Exacerbation of Pain)
Hide Description

An increase of 20 or more points on Visual Analogue Pain Scale from pain score of previous time interval

Information about the Visual Analogue Scale:

  • it consists of pain score from 0 to 100.
  • The higher the pain score; the worse the pain
  • An increase of a total of at least 20 pain score points from previous pain score reading indicate that pain has increased significantly and will be reported as "flare-up"
Time Frame 4 hours, 12 hours, day 2, day 3, and day 4
Hide Outcome Measure Data
Hide Analysis Population Description
Out of 80 patients, 12 did not return for follow-up; and no contact could be established with them. Out of these 12 patients, 7 belong to control group and 5 belong to experimental group. Hence, 33 patients in control group and 35 patients in experimental group could be analyzed
Arm/Group Title Control Group or Group I or Calcium Hydroxide Group Experimental Group or Group II or Propolis Group
Hide Arm/Group Description:
Calcium Hydroxide: it is a synthetic antimicrobial intracanal medicament and gold standard to which other medicaments are being compared. approximately 150 mg of calcium hydroxide paste will be inserted in the root canal. it will be inserted only once and will remain in root canals for 4 days.
Propolis: it is a natural product obtained from beehive. it has been evaluated for biocompatibility and toxicity; and it is found that it is extremely biocompatible material. In our study, propolis powder will be mixed with saline in a ratio of 1 : 1.5 (propolis powder(wt) / saline(vol)) to form paste; and inserted into the root canals. it will be inserted once and will remain in root canals for 4 days.
Overall Number of Participants Analyzed 33 35
Measure Type: Count of Participants
Unit of Measure: Participants
4 hours Flare up
4
  12.1%
1
   2.9%
No flare up
29
  87.9%
34
  97.1%
12 hours Flare up
0
   0.0%
4
  11.4%
No flare up
33
 100.0%
31
  88.6%
Day 2 Flare up
0
   0.0%
1
   2.9%
No flare up
33
 100.0%
34
  97.1%
Day 3 Flare up
0
   0.0%
0
   0.0%
No flare up
33
 100.0%
35
 100.0%
Day 4 Flare up
0
   0.0%
0
   0.0%
No flare up
33
 100.0%
35
 100.0%
Total Flare up
4
  12.1%
6
  17.1%
No flare up
29
  87.9%
29
  82.9%
3.Secondary Outcome
Title Difference of Pain Score Between Different Time Intervals
Hide Description

Visual Analogue Pain Score information:

  • pain intensity is measured with this scale
  • minimum pain score reading on Visual Analogue Scale is 0 and Maximum is 100
  • higher values represent worse pain and lower values represent lesser pain

this pain score is recorded pre-operatively, then at time intervals of 4 hours, 12 hours, day 2, day 3 and day 4.

the comparison of mean pain scores of different time intervals will be made.

Time Frame 4 hours, 12 hours, day 2, day 3, and day 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group or Group I or Calcium Hydroxide Group Experimental Group or Group II or Propolis Group
Hide Arm/Group Description:
Calcium Hydroxide: it is a synthetic antimicrobial intracanal medicament and gold standard to which other medicaments are being compared. approximately 150 mg of calcium hydroxide paste will be inserted in the root canal. it will be inserted only once and will remain in root canals for 4 days.
Propolis: it is a natural product obtained from beehive. it has been evaluated for biocompatibility and toxicity; and it is found that it is extremely biocompatible material. In our study, propolis powder will be mixed with saline in a ratio of 1 : 1.5 (propolis powder(wt) / saline(vol)) to form paste; and inserted into the root canals. it will be inserted once and will remain in root canals for 4 days.
Overall Number of Participants Analyzed 33 35
Mean (Standard Error)
Unit of Measure: score on a scale
Pain score difference; pre-operative - 4 hours 2.97  (3) 11.80  (2.9)
Pain score difference; 4 hours - 12 hours 2.33  (3) -1.54  (2.9)
Pain score difference; 12 hours - day 2 5.88  (3) 5.23  (2.9)
Pain score difference; day 2 - day 3 0.94  (3) 1.69  (2.9)
Pain score difference; day 3 - day 4 0.67  (3) 0.77  (2.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group or Group I or Calcium Hydroxide Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.334
Comments

The calculated p value is for the difference between pre-operative time interval and 4 hours time interval.

Threshold for statistical significance= <0.05

Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.97
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control Group or Group I or Calcium Hydroxide Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.448
Comments

The calculated p value is for the difference between time interval of 4 hours and time interval of 12 hours.

Threshold for statistical significance= <0.05

Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.33
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Control Group or Group I or Calcium Hydroxide Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.056
Comments

The calculated p value is for the difference between time intervals of 12 hours and day 2

Threshold for statistical significance= <0.05

Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 5.88
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Control Group or Group I or Calcium Hydroxide Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.760
Comments

The calculated p value is for the difference between time intervals of day 2 and day 3

Threshold for statistical significance= <0.05

Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.94
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Control Group or Group I or Calcium Hydroxide Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.828
Comments

The calculated p value is for the difference between time intervals of day 3 and day 4

Threshold for statistical significance= <0.05

Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.67
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Experimental Group or Group II or Propolis Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments

The calculated p value is for the difference between pre-operative time interval and 4 hours time interval

Threshold for statistical significance= <0.05

Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 11.80
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.9
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Experimental Group or Group II or Propolis Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.605
Comments

The calculated p value is for the difference between time interval of 4 hours and time interval of 12 hours

Threshold for statistical significance= <0.05

Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.54
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.9
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Experimental Group or Group II or Propolis Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.80
Comments

The calculated p value is for the difference between time intervals of 12 hours and day 2

Threshold for statistical significance= <0.05

Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 5.23
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.9
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Experimental Group or Group II or Propolis Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.574
Comments

The calculated p value is for the difference between time intervals of day 2 and day 3

Threshold for statistical significance= <0.05

Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.69
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.9
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Experimental Group or Group II or Propolis Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.796
Comments

The calculated p value is for the difference between time intervals of day 3 and day 4

Threshold for statistical significance= <0.05

Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.77
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.9
Estimation Comments [Not Specified]
4.Other Pre-specified Outcome
Title Difference of Pain Scores Between Males and Females
Hide Description

Information about Visual Analogue Scale for rating pain scores:

  • minimum pain score on this scale is 0 and maximum is 100
  • more the pain score; worse the pain
  • mean pain score difference between males and females at different time intervals was assessed
  • scale is divided into 4 segments: 0 to 24 (no or mild pain), 25 to 49 (moderate pain), 50 to 74 (severe pain); 75 to 100 (extreme pain).
Time Frame 4 hours, 12 hours, day 2, day 3, and day 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pain Experienced by Males Pain Experienced by Females
Hide Arm/Group Description:
Irrespective of the medicament inserted; Pain severity based of Visual analogue scale is analyzed both quantitatively and qualitatively in males.
Irrespective of the medicament inserted; Pain severity based of Visual analogue scale is analyzed both quantitatively and qualitatively in females.
Overall Number of Participants Analyzed 25 43
Mean (Standard Deviation)
Unit of Measure: score on a scale
4 hours 9.8  (11.9) 10.4  (16.9)
12 hours 11.6  (14.5) 8.8  (15.2)
Day 2 7.8  (11) 2.3  (5.8)
Day 3 5.8  (8.9) 1.40  (4)
Day 4 5  (9.2) 0.70  (2.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pain Experienced by Males, Pain Experienced by Females
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.412
Comments

The p-value calculated is for pain score difference at 4 hours

Threshold for statistical significance= <0.05

Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.6
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pain Experienced by Males, Pain Experienced by Females
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.94
Comments

The p-value calculated is for pain score difference at 12 hours

Threshold for statistical significance= <0.05

Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.8
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pain Experienced by Males, Pain Experienced by Females
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.035
Comments

The p-value calculated is for pain score difference at Day 2

Threshold for statistical significance= <0.05

Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 5.5
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Pain Experienced by Males, Pain Experienced by Females
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.023
Comments

The p-value calculated is for pain score difference at Day 3

Threshold for statistical significance= <0.05

Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 4.4
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Pain Experienced by Males, Pain Experienced by Females
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.020
Comments

The p-value calculated is for pain score difference at Day 4.

Threshold for statistical significance= <0.05

Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 4.3
Estimation Comments [Not Specified]
5.Other Pre-specified Outcome
Title Difference of Pain Scores Between Different Age Groups
Hide Description

Information about Visual Analogue Scale for rating pain scores:

  • minimum pain score on this scale is 0 and maximum is 100
  • more the pain score; worse the pain
  • mean pain score difference between different age groups: 20 to 24; 25 to 29; 30 to 34; and 35 to 40 at different time intervals was assessed
  • scale is divided into 4 segments: 0 to 24 (no or mild pain), 25 to 49 (moderate pain), 50 to 74 (severe pain); 75 to 100 (extreme pain).
Time Frame 4 hours, 12 hours, day 2, day 3, and day 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Age Group; 20 to 24 Age Group; 25 to 29 Age Group; 30 to 34 Age Group; 35 to 40
Hide Arm/Group Description:

For ease of tabulating results; patients were distributed in 4 groups according to their age: 20 to 24; 25 to 29; 30 to 34; 35 to 40

This age group consisted of total number of 6 patients. 3 belonged to control group and 3 belonged to experimental group

For ease of tabulating results; patients were distributed in 4 groups according to their age: 20 to 24; 25 to 29; 30 to 34; 35 to 40

This age group consisted of total number of 10 patients. 6 belonged to control group and 4 belonged to experimental group

For ease of tabulating results; patients were distributed in 4 groups according to their age: 20 to 24; 25 to 29; 30 to 34; 35 to 40

This age group consisted of total number of 17 patients. 6 belonged to control group and 11 belonged to experimental group

For ease of tabulating results; patients were distributed in 4 groups according to their age: 20 to 24; 25 to 29; 30 to 34; 35 to 40

This age group consisted of total number of 35 patients. 18 belonged to control group and 17 belonged to experimental group

Overall Number of Participants Analyzed 6 10 17 35
Mean (Standard Deviation)
Unit of Measure: score on a scale
Mean pain score; 4 hours 7.1  (9.1) 14.5  (15.1) 14.6  (21.2) 7.4  (12.1)
Mean pain score; 12 hours 8.3  (14.3) 12.9  (17.9) 13.6  (16.3) 7.4  (13.5)
Mean pain score; day 2 0  (0) 10.6  (13.1) 3.7  (6.9) 3.6  (7.7)
Mean pain score; day 3 1.5  (3.6) 4  (9.6) 1.5  (4.2) 3.7  (6.9)
Mean pain score; day 4 0  (0) 2.1  (6.2) 0.3  (1.2) 3.7  (7.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Age Group; 20 to 24, Age Group; 25 to 29, Age Group; 30 to 34, Age Group; 35 to 40
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.15
Comments

The p-value calculated is for pain score difference at 4 hours

Threshold for statistical significance= <0.05

Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Age Group; 20 to 24, Age Group; 25 to 29, Age Group; 30 to 34, Age Group; 35 to 40
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.36
Comments

The p-value calculated is for pain score difference at 12 hours

Threshold for statistical significance= <0.05

Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Age Group; 20 to 24, Age Group; 25 to 29, Age Group; 30 to 34, Age Group; 35 to 40
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments

The p-value calculated is for pain score difference at day 2

Threshold for statistical significance= <0.05

Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Age Group; 20 to 24, Age Group; 25 to 29, Age Group; 30 to 34, Age Group; 35 to 40
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.55
Comments

The p-value calculated is for pain score difference at day 3

Threshold for statistical significance= <0.05

Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Age Group; 20 to 24, Age Group; 25 to 29, Age Group; 30 to 34, Age Group; 35 to 40
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.17
Comments

The p-value calculated is for pain score difference at day 4

Threshold for statistical significance= <0.05

Method Kruskal-Wallis
Comments [Not Specified]
Time Frame 4 hours, 12 hours, day 2, day 3, and day 4
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Group or Group I or Calcium Hydroxide Group Experimental Group or Group II or Propolis Group
Hide Arm/Group Description Calcium Hydroxide: it is a synthetic antimicrobial intracanal medicament and gold standard to which other medicaments are being compared. approximately 150 mg of calcium hydroxide paste will be inserted in the root canal. it will be inserted only once and will remain in root canals for 4 days. Propolis: it is a natural product obtained from beehive. it has been evaluated for biocompatibility and toxicity; and it is found that it is extremely biocompatible material. In our study, propolis powder will be mixed with saline in a ratio of 1 : 1.5 (propolis powder(wt) / saline(vol)) to form paste; and inserted into the root canals. it will be inserted once and will remain in root canals for 4 days.
All-Cause Mortality
Control Group or Group I or Calcium Hydroxide Group Experimental Group or Group II or Propolis Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/40 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Control Group or Group I or Calcium Hydroxide Group Experimental Group or Group II or Propolis Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/40 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Group or Group I or Calcium Hydroxide Group Experimental Group or Group II or Propolis Group
Affected / at Risk (%) Affected / at Risk (%)
Total   4/40 (10.00%)   6/40 (15.00%) 
General disorders     
Flare-up  [1]  4/40 (10.00%)  6/40 (15.00%) 
Indicates events were collected by systematic assessment
[1]
Increase of 20 or more pain score points from pain score of previous time interval on Visual Analogue Scale
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Juzer Shabbir Saifee
Organization: Dow University of Health Sciences
Phone: 92-333-2352134
EMail: dr.juzer.shabbir@gmail.com
Layout table for additonal information
Responsible Party: Juzer Shabbir Saifee, Dow University of Health Sciences
ClinicalTrials.gov Identifier: NCT03723980     History of Changes
Other Study ID Numbers: MDSJUZER
ISRCTN66816132 ( Registry Identifier: SPRINGER NATURE )
First Submitted: October 23, 2018
First Posted: October 30, 2018
Results First Submitted: November 4, 2018
Results First Posted: June 6, 2019
Last Update Posted: June 6, 2019