Role of Propolis Endodontic Irrigant on Post-Operative Pain

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

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.

Study Overview

• Status: Completed
• Conditions: Symptomatic Irreversible Pulpitis; Post-operative Pain
• Intervention / Treatment: Drug: Sodium hypochlorite 5.25%; Drug: Propolis 20%

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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Tayyaba Tahira, BDS FCPS; Phone Number: 923222253971; Email: tayyaba.tahira@duhs.edu.pk
• Study Contact Backup: Name: Farah Naz, BDS FCPS; Email: farah.naz@duhs.edu.pk

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 75500
      • Dow International Dental College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sodium Hypochlorite; 5.25% sodium hypochlorite is the gold standard endodontic irrigant. Other Name: NaOCl	Drug: Sodium hypochlorite 5.25%; 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.; Other Names: NaOCl
Experimental: Propolis; Hydroalcoholic 20% propolis will be used as an endodontic irrigant. Other Name: Bee glue	Drug: Propolis 20%; In group B, a 20% hydroalcoholic propolis solution of 3 milliliters will be used to irrigate each canal, between each instrument.; Other Names: Bee glue

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dow University of Health Sciences
• Investigators: Principal Investigator: Tayyaba Tahira, BDS FCPS, Dow International Dental College, Dow University of Health Sciences; Study Director: Farah Naz, BDS FCPS, Dow International Dental College, Dow University of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Actual): August 15, 2023
• Study Completion (Actual): August 15, 2023

Study Registration Dates

• First Submitted: July 16, 2023
• First Submitted That Met QC Criteria: July 26, 2023
• First Posted (Actual): August 3, 2023

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 2, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Propolis; Endodontic Irrigant
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pain, Postoperative; Pulpitis; Anti-Infective Agents; Disinfectants; Sodium Hypochlorite; Eusol; Propolis
• Other Study ID Numbers: 2908

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Only investigators and co-investigators of this study will be able to access to participants' personal data.

Ownership of the data will remain with the principal investigator and Department of Operative Dentistry, Dow International Dental College(DIDC) , Dow University of Health Sciences

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No