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

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: 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

Brief Summary:
This study evaluates the role of propolis paste as compared to calcium hydroxide (when used as intracanal medication) in prevention and treatment of pain after root canal treatment in necrotic (infected) teeth. Half of the participants will receive calcium hydroxide, while the other half will receive propolis.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Propolis Drug: Calcium Hydroxide Phase 3

Detailed Description:

Propolis is a developing herbal medicament used in various aspects on dentistry. it is extremely biocompatible; has flavanoids; which acts as anti-inflammatory and antimicrobial components.

Calcium hydroxide is a synthetic medication which is antibacterial


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Effect of Propolis Paste as Intracanal Medicament on Post-Endodontic Pain: a Double-Blind Randomized Clinical Trial.
Actual Study Start Date : November 16, 2017
Actual Primary Completion Date : April 24, 2018
Actual Study Completion Date : October 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium

Arm Intervention/treatment
Active Comparator: Control Group or Group I or Calcium hydroxide Group Drug: 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.

Experimental: Experimental Group or Group II or Propolis Group Drug: 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.
Other Name: Bee glue




Primary Outcome Measures :
  1. Pain Intensity Measure: Visual Analogue Pain Scale [ Time Frame: 4 hours, 12 hours, day 2, day 3 and day 4 ]

    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)



Secondary Outcome Measures :
  1. Acute Increase in Pain Score (Acute Exacerbation of Pain) [ Time Frame: 4 hours, 12 hours, day 2, day 3, and day 4 ]

    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"

  2. Difference of Pain Score Between Different Time Intervals [ Time Frame: 4 hours, 12 hours, day 2, day 3, and day 4 ]

    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.



Other Outcome Measures:
  1. Difference of Pain Scores Between Males and Females [ Time Frame: 4 hours, 12 hours, day 2, day 3, and day 4 ]

    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).

  2. Difference of Pain Scores Between Different Age Groups [ Time Frame: 4 hours, 12 hours, day 2, day 3, and day 4 ]

    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).



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Single rooted Necrotic teeth with symptomatic or asymptomatic periapical periodontitis having periapical widening or radiolucency without bone expansion (PAI index 2, 3 and 4).
  • Teeth with favorable root morphology.
  • Teeth with closed apex.

Exclusion Criteria:

  • Teeth with PAI index 1 and 5.
  • Patients who are on antibiotics.
  • Patient with recent trauma to the jaw.
  • Teeth with open apex
  • Multi-rooted teeth.
  • Vital teeth.
  • Non-restorable teeth.
  • Unfavorable root morphology (severely curved, dilacerated, severely sclerosed or obliterated).
  • Teeth associated with soft tissue abscess or swelling.
  • Teeth with external or internal root resorption
  • Re-treatment cases.
  • Periodontally compromised teeth (like mobile teeth and teeth with excessive bone loss).
  • Teeth requiring endodontic surgery.
  • Teeth requiring non-surgical endodontic treatment of multiple teeth in the same or opposing quadrant.
  • Medically compromised patients (ASA-III and above), patients with special communication needs or who doesn't understand Urdu or English language.
  • Patients allergic to bee pollen or honey products.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03723980


Locations
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Pakistan
Dow International Dental College
Karachi, Sindh, Pakistan, 75500
Sponsors and Collaborators
Juzer Shabbir Saifee
Dow University of Health Sciences
Investigators
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Principal Investigator: Juzer S Saifee Dow University of Health Sciences
Study Director: Fazal R Qazi Dow University of Health Sciences
  Study Documents (Full-Text)

Documents provided by Juzer Shabbir Saifee, Dow University of Health Sciences:

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Responsible Party: Juzer Shabbir Saifee, Principal Investigator, Dow University of Health Sciences
ClinicalTrials.gov Identifier: NCT03723980     History of Changes
Other Study ID Numbers: MDSJUZER
ISRCTN66816132 ( Registry Identifier: SPRINGER NATURE )
First Posted: October 30, 2018    Key Record Dates
Results First Posted: June 6, 2019
Last Update Posted: June 6, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Juzer Shabbir Saifee, Dow University of Health Sciences:
Flare up
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Calcium, Dietary
Propolis
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Anti-Infective Agents