Role of Propolis Endodontic Irrigant on Post-Operative Pain

Sponsor

Dow University of Health Sciences (Other)

Overall Status

Recruiting

CT.gov ID

NCT05974748

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

8.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Post-operative Pain Symptomatic Irreversible Pulpitis	Drug: Sodium hypochlorite 5.25% Drug: Propolis 20%	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Double (Participant, Outcomes 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.

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Jul 30, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dow International Dental College	Karachi	Sindh	Pakistan	75500

Sponsors and Collaborators

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