Role of Propolis Endodontic Irrigant on Post-Operative Pain

Study Overview
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Brief Summary
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The goal of this clinical trial is to compare propolis and sodium hypochlorite as endodontic irrigants in patients presenting with symptomatic irreversible pulpitis. . The main question it aims to answer is: • if there is any analgesic effects of 20% Propolis compared with 5.25% NaOCl on the intensity of post-operative pain in patients with symptomatic irreversible pulpitis using VAS pain score. Participants will undergo root canal treatment of their teeth using either 20% propolis solution or 5.25% NaOCl in their first visit of a multi-visit root canal treatment. Researchers will compare 20% Propolis and 5.25% NaOCl to see reduction in Intensity of Post-Operative Pain using visual analogue scale over 72 hour duration.

Detailed Description
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Sodium hypochlorite as an endodontic irrigant, poses problems of toxicity. Additionally, its unfavorable odor, taste, failure to remove the smear layer, and proteolytic effect have deleterious effects on the dentine, creating unfavorable structural and mechanical alterations . To get beyond NaOCl limits and adverse effects, it is necessary to look for a biocompatible, equally effective, and dentine friendly irrigant with greater patient acceptance in taste and odor. The literature lacks an in-vivo study that investigates the anti-inflammatory with analgesic characteristics of Propolis on post-endodontic pain as an irrigant, in patients with symptomatic irreversible pulpitis. This research will endeavor to fill this gap in literature.

Official Title
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Comparative Evaluation of Propolis and Sodium Hypochlorite as Endodontic Irrigants on Post-Operative Pain in Patients With Symptomatic Irreversible Pulpitis

Conditions
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Post-operative Pain, Symptomatic Irreversible Pulpitis

Intervention / Treatment
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* Drug: Sodium hypochlorite 5.25%
* Drug: Propolis 20%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA-I and II individuals who are between the ages of 18 and 60 years. Patients with mandibular and maxillary premolars who have been diagnosed with symptomatic irreversible pulpitis (with either a normal periapex or symptomatic apical periodontitis). Patients who score moderate to severe (4-10) on a preoperative visual analogue scale (VAS=1-10) Exclusion Criteria: Patients suffering from severe pain because of traumatic occlusion. Teeth with extensive damage, calcified canals, periapical radiolucency, root resorption, and an open apex. Patients with compromised medical condition (ASA-III and above) Patients who are unable to communicate effectively in either Urdu or English. Pregnant and lactating ladies Patients who are allergic to honey or bee pollen.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2 interventional groups assigned. 1 will be receiving routine intervention and other is the experimental group.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sodium Hypochlorite<br>5.25% sodium hypochlorite is the gold standard endodontic irrigant. Other Name: NaOCl | Drug: Sodium hypochlorite 5.25%<br>* The participants will be randomly divided into two groups using the sealed envelope method during the instrumentation process. The clinician will use the irrigation in accordance with the protocol. Between each instrument in group A, 3 ml of 5.25% sodium hypochlorite (NaOCl) will be used to irrigate each canal.<br>* Other names: NaOCl;|
| Experimental: Propolis<br>Hydroalcoholic 20% propolis will be used as an endodontic irrigant. Other Name: Bee glue | Drug: Propolis 20%<br>* In group B, a 20% hydroalcoholic propolis solution of 3 milliliters will be used to irrigate each canal, between each instrument.<br>* Other names: Bee glue;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in post-operative pain intensity on visual analogue scale(0-10) | Self recorded by patient and then assessed by an intern on a visual analogue scale of 0-10 with 0 being no pain , 10 being worst pain | 24 hours, 48 hours and 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need of rescue medicine in both groups | Self recorded by patient and then assessed by an intern on a visual analogue scale of 0-10 with 0 being no pain , 10 being worst pain | within first 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Propolis, Endodontic Irrigant