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

Effect of Propolis Paste as Intracanal Medicament on Post-Endodontic Pain: a Double-Blind Randomized Clinical Trial.

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Calcium Hydroxide; Drug: 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

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 3

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 75500
      • Dow International Dental College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 36 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Bee glue

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	4 hours, 12 hours, day 2, day 3 and day 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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"	4 hours, 12 hours, day 2, day 3, and day 4
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.	4 hours, 12 hours, day 2, day 3, and day 4

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference of Pain Scores Between Males and Females	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).	4 hours, 12 hours, day 2, day 3, and day 4
Difference of Pain Scores Between Different Age Groups	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).	4 hours, 12 hours, day 2, day 3, and day 4

Collaborators and Investigators

• Sponsor: Juzer Shabbir Saifee
• Collaborators: Dow University of Health Sciences
• Investigators: Principal Investigator: Juzer S Saifee, Dow University of Health Sciences; Study Director: Fazal R Qazi, Dow University of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2017
• Primary Completion (Actual): April 24, 2018
• Study Completion (Actual): October 15, 2018

Study Registration Dates

• First Submitted: October 23, 2018
• First Submitted That Met QC Criteria: October 26, 2018
• First Posted (Actual): October 30, 2018

Study Record Updates

• Last Update Posted (Actual): June 6, 2019
• Last Update Submitted That Met QC Criteria: March 3, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Flare up
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Anti-Infective Agents; Calcium-Regulating Hormones and Agents; Calcium; Propolis
• Other Study ID Numbers: MDSJUZER; ISRCTN66816132 (Registry Identifier: SPRINGER NATURE)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No