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

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Phase 3
Locations
Pakistan
Study Type
Interventional
Intervention
Propolis
Calcium Hydroxide
Sponsored by
Juzer Shabbir Saifee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain, Postoperative focused on measuring Flare up

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Dow International Dental College

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group or Group I or Calcium hydroxide Group

Experimental Group or Group II or Propolis Group

Arm Description

Outcomes

Primary Outcome Measures

Pain Intensity Measure: Visual Analogue Pain Scale
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

Acute Increase in Pain Score (Acute Exacerbation of Pain)
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"
Difference of Pain Score Between Different Time Intervals
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.

Full Information

First Posted
October 23, 2018
Last Updated
March 3, 2019
Sponsor
Juzer Shabbir Saifee
Collaborators
Dow University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03723980
Brief Title
Role of Propolis Paste in Preventing Pain After Root Canal Treatment.
Official Title
Effect of Propolis Paste as Intracanal Medicament on Post-Endodontic Pain: a Double-Blind Randomized Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
November 16, 2017 (Actual)
Primary Completion Date
April 24, 2018 (Actual)
Study Completion Date
October 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Juzer Shabbir Saifee
Collaborators
Dow University of Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Flare up

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group or Group I or Calcium hydroxide Group
Arm Type
Active Comparator
Arm Title
Experimental Group or Group II or Propolis Group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Propolis
Other Intervention Name(s)
Bee glue
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Calcium Hydroxide
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain Intensity Measure: Visual Analogue Pain Scale
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
Secondary Outcome Measure Information:
Title
Acute Increase in Pain Score (Acute Exacerbation of Pain)
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
Title
Difference of Pain Score Between Different Time Intervals
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
Other Pre-specified Outcome Measures:
Title
Difference of Pain Scores Between Males and Females
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
Title
Difference of Pain Scores Between Different Age Groups
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juzer S Saifee
Organizational Affiliation
Dow University of Health Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fazal R Qazi
Organizational Affiliation
Dow University of Health Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Dow International Dental College
City
Karachi
State/Province
Sindh
ZIP/Postal Code
75500
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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