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

Phase 3

Completed

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

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Control Group or Group I or Calcium hydroxide Group	Calcium Hydroxide	-
Experimental Group or Group II or Propolis Group	Propolis	-

Primary Outcome Measures

Name	Time	Method
Pain Intensity Measure: Visual Analogue Pain Scale	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

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