Effect of Propolis Paste as Intracanal Medicament on Post-Endodontic Pain: a Double-Blind Randomized Clinical Trial.
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Pain Intensity Measure: Visual Analogue Pain Scale
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •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.
Arms & Interventions
Control Group or Group I or Calcium hydroxide Group
Intervention: Calcium Hydroxide (Drug)
Experimental Group or Group II or Propolis Group
Intervention: Propolis (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- 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)
Investigators
Juzer Shabbir Saifee
Principal Investigator
Dow University of Health Sciences