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Role of Propolis Endodontic Irrigant on Post-Operative Pain

Primary Purpose

Post-operative Pain, Symptomatic Irreversible Pulpitis

Status

Completed

Phase

Phase 3

Locations

Pakistan

Study Type

Interventional

Intervention

Sodium hypochlorite 5.25%

Propolis 20%

About this trial

This is an interventional prevention trial for Post-operative Pain focused on measuring Propolis, Endodontic Irrigant

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Dow International Dental College

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Sodium Hypochlorite

Propolis

Arm Description

5.25% sodium hypochlorite is the gold standard endodontic irrigant. Other Name: NaOCl

Hydroalcoholic 20% propolis will be used as an endodontic irrigant. Other Name: Bee glue

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT05974748

First Posted

July 16, 2023

Last Updated

September 2, 2023

Sponsor

Dow University of Health Sciences

1. Study Identification

Unique Protocol Identification Number

NCT05974748

Brief Title

Role of Propolis Endodontic Irrigant on Post-Operative Pain

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

April 1, 2023 (Actual)

Primary Completion Date

August 15, 2023 (Actual)

Study Completion Date

August 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dow University of Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post-operative Pain, Symptomatic Irreversible Pulpitis

Keywords

Propolis, Endodontic Irrigant

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

2 interventional groups assigned. 1 will be receiving routine intervention and other is the experimental group.

Masking

ParticipantOutcomes Assessor

Masking Description

Participants will not be aware of their interventional group. A proforma and pain intensity scale will be provided to the patient by an intern not involved in the study, to be completed at 24, 48, and 72 hours following the procedure to assess post-operative pain. this proforma will be collected and assessed by the intern.

Allocation

Randomized

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sodium Hypochlorite

Arm Type

Active Comparator

Arm Description

5.25% sodium hypochlorite is the gold standard endodontic irrigant. Other Name: NaOCl

Arm Title

Propolis

Arm Type

Experimental

Arm Description

Hydroalcoholic 20% propolis will be used as an endodontic irrigant. Other Name: Bee glue

Intervention Type

Drug

Intervention Name(s)

Sodium hypochlorite 5.25%

Other Intervention Name(s)

NaOCl

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Propolis 20%

Other Intervention Name(s)

Bee glue

Intervention Description

In group B, a 20% hydroalcoholic propolis solution of 3 milliliters will be used to irrigate each canal, between each instrument.

Primary Outcome Measure Information:

Title

Change in post-operative pain intensity on visual analogue scale(0-10)

Description

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

Time Frame

24 hours, 48 hours and 72 hours

Secondary Outcome Measure Information:

Title

Need of rescue medicine in both groups

Description

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

Time Frame

within first 24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tayyaba Tahira, BDS FCPS

Organizational Affiliation

Dow International Dental College, Dow University of Health Sciences

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Farah Naz, BDS FCPS

Organizational Affiliation

Dow International Dental College, Dow University of Health Sciences

Official's Role

Study Director

Facility Information:

Facility Name

Dow International Dental College

City

Karachi

State/Province

Sindh

ZIP/Postal Code

75500

Country

Pakistan

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing 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

Learn more about this trial

Role of Propolis Endodontic Irrigant on Post-Operative Pain

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