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

NCT03723980 | Completed Phase 3 Results DMC

• 2 other identifiers: MDSJUZERISRCTN66816132
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Keywords

Flare up

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Acute Increase in Pain Score (Acute Exacerbation of Pain)

  4 hours, 12 hours, day 2, day 3, and day 4

• Difference of Pain Score Between Different Time Intervals

  4 hours, 12 hours, day 2, day 3, and day 4

Other Outcomes (2)

• Difference of Pain Scores Between Males and Females

  4 hours, 12 hours, day 2, day 3, and day 4

• Difference of Pain Scores Between Different Age Groups

  4 hours, 12 hours, day 2, day 3, and day 4

Study Arms (2)

Control Group or Group I or Calcium hydroxide Group

ACTIVE COMPARATOR

Drug: Calcium Hydroxide

Experimental Group or Group II or Propolis Group

EXPERIMENTAL

Drug: Propolis

Interventions

Propolis DRUG

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.

Also known as: Bee glue

Experimental Group or Group II or Propolis Group

Calcium Hydroxide DRUG

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.

Control Group or Group I or Calcium hydroxide Group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Juzer Shabbir Saifee: lead
• Dow University of Health Sciences: collaborator

Study Sites (1)

Dow International Dental College

Karachi, Sindh, 75500, Pakistan

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Propolis; Calcium Hydroxide

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Resins, Plant; Biopolymers; Polymers; Macromolecular Substances; Plant Exudates; Biological Products; Complex Mixtures; Hydroxides; Alkalies; Inorganic Chemicals; Calcium Compounds; Anions; Ions; Electrolytes

Results Point of Contact

• Title: Dr. Juzer Shabbir Saifee
• Organization: Dow University of Health Sciences

dr.juzer.shabbir@gmail.com

92-333-2352134

Study Officials

• Juzer S Saifee

  Dow University of Health Sciences

  PRINCIPAL INVESTIGATOR

• Fazal R Qazi

  Dow University of Health Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 23, 2018
• First Posted: October 30, 2018
• Study Start: November 16, 2017
• Primary Completion: April 24, 2018
• Study Completion: October 15, 2018
• Last Updated: June 6, 2019
• Results First Posted: June 6, 2019

Record last verified: 2019-03

Locations

PA (1)