Role of Propolis Endodontic Irrigant on Post-Operative Pain

Phase 3

Completed

• Conditions: Post-operative Pain; Symptomatic Irreversible Pulpitis
• Interventions: Drug: Propolis 20%; Drug: Sodium hypochlorite 5.25%

• Registration Number: NCT05974748
• Lead Sponsor: Dow University of Health Sciences

Brief Summary

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

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.

Study Timeline

• Study Start: 2023-04-01
• Study First Submitted: 2023-07-16
• Study First Submitted QC: 2023-07-26
• Study First Posted: 2023-08-03
• Primary Completion: 2023-08-15
• Study Completion: 2023-08-15
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-02
• Last Update Posted: 2023-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

1. ASA-I and II individuals who are between the ages of 18 and 60 years.
2. Patients with mandibular and maxillary premolars who have been diagnosed with symptomatic irreversible pulpitis (with either a normal periapex or symptomatic apical periodontitis).
3. Patients who score moderate to severe (4-10) on a preoperative visual analogue scale (VAS=1-10)

Exclusion Criteria

1. Patients suffering from severe pain because of traumatic occlusion.
2. Teeth with extensive damage, calcified canals, periapical radiolucency, root resorption, and an open apex.
3. Patients with compromised medical condition (ASA-III and above)
4. Patients who are unable to communicate effectively in either Urdu or English.
5. Pregnant and lactating ladies
6. Patients who are allergic to honey or bee pollen.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propolis	Propolis 20%	Hydroalcoholic 20% propolis will be used as an endodontic irrigant. Other Name: Bee glue
Sodium Hypochlorite	Sodium hypochlorite 5.25%	5.25% sodium hypochlorite is the gold standard endodontic irrigant. Other Name: NaOCl

Primary Outcome Measures

Name	Time	Method
Change in post-operative pain intensity on visual analogue scale(0-10)	24 hours, 48 hours and 72 hours	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

Secondary Outcome Measures

Name	Time	Method
Need of rescue medicine in both groups	within first 24 hours	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

Trial Locations

Locations (1)

Dow International Dental College; 🇵🇰 Karachi, Sindh, Pakistan