Role of Propolis Endodontic Irrigant on Post-Operative Pain

Post-operative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05974748
• Other study ID #: 2908
• Status: Completed
• Phase: Phase 3
• Start date: April 1, 2023
• Est. completion date: August 15, 2023

Study information

• Verified date: September 2023
• Source: Dow University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: August 15, 2023
• Est. primary completion date: August 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Post-operative Pain
• Pulpitis
• Symptomatic Irreversible Pulpitis

Intervention

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

Locations

Country	Name	City	State
Pakistan	Dow International Dental College	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Dow University of Health Sciences

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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