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Effect of Non-surgical Periodontal Therapy on Gingival Crevicular Fluid Interleukin-21 Levels

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02861937
Recruitment Status : Completed
First Posted : August 10, 2016
Results First Posted : August 26, 2020
Last Update Posted : September 2, 2020
Sponsor:
Information provided by (Responsible Party):
Krishnadevaraya College of Dental Sciences & Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Chronic Peridontitis Patients
Chronic Gingivitis
Healthy
Intervention Procedure: non surgical periodontal therapy
Enrollment 34
Recruitment Details Thirty four patients (19 males and 15 females, aged 20-60 years) were consecutively enrolled over a six month period (April 2014 to September 2014) from the outpatient department of periodontology, Krishnadevaraya College of Dental Sciences, Bangalore, and Karnataka.
Pre-assignment Details 12 chronic gingivitis, 12 chronic periodontitis patients and 10 healthy individuals were included as control. Patients systemically healthy having more than or equal to 14 functional teeth, patients had not received any form of surgical/non surgical periodontal therapy or received antibiotics within the past 6 months.
Arm/Group Title Group I (Control Group): Healthy Group II (Test Group I): Chronic Gingivitis Group III (Test Group II): Chronic Periodontitis
Hide Arm/Group Description Ten patients with clinically healthy gingiva with probing depth less than 3mm and less than or equal to 10% sites with gingival bleeding on probing present. Twelve chronic gingivitis patients having probing depth less than or equal to 4mm and Relative Attachment Level (RAL) less than or equal to 3mm, with more than 25% of sites with gingival bleeding present. Twelve chronic periodontitis patients having probing depth more than or equal to 5mm and Relative Attachment Level of more than or equal to 8mm with more than 10% of sites with gingival bleeding on probing present with radiographic evidence of bone loss.
Period Title: Overall Study
Started 10 12 12
Completed 10 12 12
Not Completed 0 0 0
Arm/Group Title Group I (Control Group): Healthy Group II (Test Group I): Chronic Gingivitis Group III (Test Group II): Chronic Periodontitis Total
Hide Arm/Group Description Ten patients with clinically healthy gingiva with probing depth less than 3mm and less than or equal to 10% sites with gingival bleeding on probing present.

Chronic gingivitis was defined as having probing depth (PD) less than or equal to 4mm, relative attachment loss (RAL) ) less than or equal to 3mm and more than to 25% sites with gingival bleeding present (BOP)

Non surgical periodontal therapy (SRP) was concluded in 3 weeks. Within the duration of the study, all subjects received supportive therapy

non surgical periodontal therapy: and root planing (SRP) was performed in two to four appointments lasting approximately 60 minutes each under local anaesthesia (2% lignocaine hydrochloride with 1:2,00,000 adrenaline) using area specific Gracey periodontal curettes and an ultrasonic device. The treatment was concluded in 3 weeks. Within the duration of the study, all subjects received supportive therapy, which included professional plaque control and reinstruction of oral hygiene.

Chronic periodontitis was defined as having probing depth more than or equal to 5mm, RAL more than or equal to 8mm, with more than or equal to 10% sites with BOP positive and evidence of bone loss determined radiographically.

Non surgical periodontal therapy (SRP) was concluded in 3 weeks. Within the duration of the study, all subjects received supportive therapy

non surgical periodontal therapy: and root planing (SRP) was performed in two to four appointments lasting approximately 60 minutes each under local anaesthesia (2% lignocaine hydrochloride with 1:2,00,000 adrenaline) using area specific Gracey periodontal curettes and an ultrasonic device. The treatment was concluded in 3 weeks. Within the duration of the study, all subjects received supportive therapy, which included professional plaque control and reinstruction of oral hygiene.

Total of all reporting groups
Overall Number of Baseline Participants 10 12 12 34
Hide Baseline Analysis Population Description
A total of 34 patients with 19 males and 15 females in the age group of 20-60 years were included. Patients were divided into 3 groups to collect Gingival Crevicular Fluid (GCF) samples for the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 12 participants 12 participants 34 participants
30  (0.465) 25  (0.359) 44  (0.981) 33  (7.73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 12 participants 12 participants 34 participants
Female
5
  50.0%
6
  50.0%
4
  33.3%
15
  44.1%
Male
5
  50.0%
6
  50.0%
8
  66.7%
19
  55.9%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
India Number Analyzed 10 participants 12 participants 12 participants 34 participants
10
 100.0%
12
 100.0%
12
 100.0%
34
 100.0%
1.Primary Outcome
Title Pocket Depth
Hide Description Probing pocket depth (PPD) was recorded using University of North Carolina {UNC}-15 Periodontal probe and customized occlusal stent. Pocket depth was recorded from the crest of the gingival margin to the base of the pocket. The deepest probing pocket depth in the patient"s mouth was considered.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group I (Control Group) Group II (Test Group I) Group III (Test Group II)
Hide Arm/Group Description:
Ten patients with clinically healthy gingiva with probing depth less than 3mm and less than or equal to 10% sites with gingival bleeding on probing present.
Twelve chronic gingivitis patients having probing depth less than or equal to 4mm and Relative Attachment Level (RAL) less than or equal to 3mm, with more than 25% of sites with gingival bleeding present.
Twelve chronic periodontitis patients having probing depth more than or equal to 5mm and Relative Attachment Level of more than or equal to 8mm with more than 10% of sites with gingival bleeding on probing present with radiographic evidence of bone loss.
Overall Number of Participants Analyzed 10 12 12
Mean (Standard Deviation)
Unit of Measure: millimetres
1.60  (0.516) 2.50  (0.522) 6.75  (1.138)
2.Primary Outcome
Title Gingival Index
Hide Description

The severity of Gingivitis was scored on the distolabial papillae, facial margins, mesiolabial papillae and entire lingual gingival margin of each tooth. A blunt instrument such as Periodontal probe was used to assess the bleeding.

0-Absence of inflammation/normal gingival

  1. Mild inflammation, slight change in color, slight edema; no bleeding on probing
  2. Moderate inflammation; moderate glazing, redness, edema and hypertrophy. Bleeding on probing.The higher the score,worst the outcome
  3. Severe inflammation; marked redness, hypertrophy and ulceration. Tendency to spontaneous bleeding.

Gingival Score Degree of gingivitis 0.1-1.0-Mild gingivitis 1.1-2.0-Moderate gingivitis 2.1-3.0-Severe gingivitis

Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group I (Control Group) Group II (Test Group I) Group III (Test Group II)
Hide Arm/Group Description:
Ten patients with clinically healthy gingiva with probing depth less than 3mm and less than or equal to 10% sites with gingival bleeding on probing present.
Twelve chronic gingivitis patients having probing depth less than or equal to 4mm and Relative Attachment Level (RAL) less than or equal to 3mm, with more than 25% of sites with gingival bleeding present.
Twelve chronic periodontitis patients having probing depth more than or equal to 5mm and Relative Attachment Level of more than or equal to 8mm with more than 10% of sites with gingival bleeding on probing present with radiographic evidence of bone loss.
Overall Number of Participants Analyzed 10 12 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.30  (0.041) 1.71  (0.465) 2.24  (0.359)
3.Primary Outcome
Title Plaque Index
Hide Description

The surfaces examined are the four gingival areas of the tooth i,e the distolabial, facial, mesiolabial, and lingual surfaces. Mouth mirror, a light source, a dental explorer, and air drying of the teeth and gingiva were used.

SCORE CRITERIA 0 No plaque in gingival area

  1. No plaque can be observed by naked eye. A film of plaque adhering to the free gingival margin and adjacent area of the tooth recognized only by running a probe across the tooth surface.
  2. Moderate accumulation of soft deposits within the gingival pockets or on the tooth and gingival margin, which can be seen with naked eye.
  3. Abundance of soft matter within the gingival pocket and or on the tooth surface and gingival margin. The interdental area is stuffed with soft debris.

Plaque Score:Oral Hygiene Status 0:Excellent 0.1-0.9:Good 1.0-1.9:Fair 2.0-3.0:Poor. The higher the value,worst is the outcome.

Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group I (Control Group) Group II (Test Group I) Group III (Test Group II)
Hide Arm/Group Description:
Ten patients with clinically healthy gingiva with probing depth less than 3mm and less than or equal to 10% sites with gingival bleeding on probing present.
Twelve chronic gingivitis patients having probing depth less than or equal to 4mm and Relative Attachment Level (RAL) less than or equal to 3mm, with more than 25% of sites with gingival bleeding present.
Twelve chronic periodontitis patients having probing depth more than or equal to 5mm and Relative Attachment Level of more than or equal to 8mm with more than 10% of sites with gingival bleeding on probing present with radiographic evidence of bone loss.
Overall Number of Participants Analyzed 10 12 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.31  (0.068) 1.18  (0.597) 2.14  (0.330)
4.Primary Outcome
Title Relative Attachment Level:
Hide Description

RAL was measured using UNC-15 periodontal probe and customized acrylic stent. This measurement was made from a fixed reference point from the occlusal surface of the acrylic stent to the base of the periodontal pocket.

No Relative Attachment Level (RAL) :healthy No Relative Attachment Level (RAL) : chronic gingivitis Relative Attachment Level (RAL) more than or equal to 8mm : chronic periodontitis

Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group I (Control Group) Group II (Test Group I) Group III (Test Group II)
Hide Arm/Group Description:
Ten patients with clinically healthy gingiva with probing depth less than 3mm and less than or equal to 10% sites with gingival bleeding on probing present.
Twelve chronic gingivitis patients having probing depth less than or equal to 4mm, with no Relative Attachment loss (RAL)and with more than 25% of sites with gingival bleeding present.
Twelve chronic periodontitis patients having probing depth more than or equal to 5mm and Relative Attachment Level of more than or equal to 8mm with more than 10% of sites with gingival bleeding on probing present with radiographic evidence of bone loss.
Overall Number of Participants Analyzed 10 12 12
Mean (Standard Deviation)
Unit of Measure: millimetres
0  (0) 0  (0) 9.50  (1.243)
5.Primary Outcome
Title Interleukin-21(IL-21) Cytokine Levels
Hide Description IL-21 levels in Gingival crevicular fluid {GCF} was determined by using ELISA kit. Quantikine human IL-21 immunoassay was done according to manufacturer"s instructions (MABTECH SWEDEN)®. ELISA reader was used to record the optical density of the tested samples.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group I (Control Group) Group II (Test Group I) Group III (Test Group II)
Hide Arm/Group Description:
Ten patients with clinically healthy gingiva with probing depth less than 3mm and less than or equal to 10% sites with gingival bleeding on probing present.
Twelve chronic gingivitis patients having probing depth less than or equal to 4mm and Relative Attachment Level (RAL) less than or equal to 3mm, with more than 25% of sites with gingival bleeding present.
Twelve chronic periodontitis patients having probing depth more than or equal to 5mm and Relative Attachment Level of more than or equal to 8mm with more than 10% of sites with gingival bleeding on probing present with radiographic evidence of bone loss.
Overall Number of Participants Analyzed 10 12 12
Mean (Standard Deviation)
Unit of Measure: picogram per millilitres
2245.900  (771.718) 7215.341  (1125.553) 7390.167  (1982.4)
Time Frame 6 weeks
Adverse Event Reporting Description The Total Number of Participants at Risk equals the number of participants Started in the Participant Flow module, but All-Cause Mortality, Serious, or Other (non-serious) Adverse Events were observed in none.
 
Arm/Group Title Group I (Control Group) Group II (Test Group I) Group III (Test Group II)
Hide Arm/Group Description Ten patients with clinically healthy gingiva with probing depth less than 3mm and less than or equal to 10% sites with gingival bleeding on probing present. Twelve chronic gingivitis patients having probing depth less than or equal to 4mm and Relative Attachment Level (RAL) less than or equal to 3mm, with more than 25% of sites with gingival bleeding present. Twelve chronic periodontitis patients having probing depth more than or equal to 5mm and Relative Attachment Level of more than or equal to 8mm with more than 10% of sites with gingival bleeding on probing present with radiographic evidence of bone loss.
All-Cause Mortality
Group I (Control Group) Group II (Test Group I) Group III (Test Group II)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/12 (0.00%)   0/12 (0.00%) 
Hide Serious Adverse Events
Group I (Control Group) Group II (Test Group I) Group III (Test Group II)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/12 (0.00%)   0/12 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group I (Control Group) Group II (Test Group I) Group III (Test Group II)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/12 (0.00%)   0/12 (0.00%) 
This study needs to be elucidated with larger sample size and for longer duration, on arresting periodontal disease progression/disease activity by assessing the IL-21 levels.
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. Rudrakshi C
Organization: Krishnadevaraya college of dental sciences
Phone: 080-28467083
EMail: drrudrakshi@rediffmail.com
Layout table for additonal information
Responsible Party: Krishnadevaraya College of Dental Sciences & Hospital
ClinicalTrials.gov Identifier: NCT02861937    
Other Study ID Numbers: 02-D012-36773
First Submitted: July 8, 2016
First Posted: August 10, 2016
Results First Submitted: May 17, 2017
Results First Posted: August 26, 2020
Last Update Posted: September 2, 2020