Clinical trial NCT03723980: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain, Postoperative
Keywords: Flare up
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
Collaborators: name: Dow University of Health Sciences
First posted: 2018-10-30
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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.

Primary outcomes:
measure: Pain Intensity Measure: Visual Analogue Pain Scale
timeFrame: 4 hours, 12 hours, day 2, day 3 and day 4
Secondary outcomes:
measure: Acute Increase in Pain Score (Acute Exacerbation of Pain)
timeFrame: 4 hours, 12 hours, day 2, day 3, and day 4
measure: Difference of Pain Score Between Different Time Intervals
timeFrame: 4 hours, 12 hours, day 2, day 3, and day 4
Other outcomes:
measure: Difference of Pain Scores Between Males and Females
timeFrame: 4 hours, 12 hours, day 2, day 3, and day 4
measure: Difference of Pain Scores Between Different Age Groups
timeFrame: 4 hours, 12 hours, day 2, day 3, and day 4
Locations:
city: Karachi
country: Pakistan
facility: Dow International Dental College
state: Sindh
Study officials:
affiliation: Dow University of Health Sciences
name: Juzer S Saifee
role: PRINCIPAL_INVESTIGATOR
affiliation: Dow University of Health Sciences
name: Fazal R Qazi
role: STUDY_DIRECTOR
References: