Role of Propolis Endodontic Irrigant on Post-Operative Pain

NCT05974748 | Completed Phase 3

• 1 other identifier: 2908
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-operative Pain; Symptomatic Irreversible Pulpitis

Keywords

Propolis; Endodontic Irrigant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Need of rescue medicine in both groups

  within first 24 hours

Study Arms (2)

Sodium Hypochlorite

ACTIVE COMPARATOR

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

Drug: Sodium hypochlorite 5.25%

Propolis

EXPERIMENTAL

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

Drug: Propolis 20%

Interventions

Sodium hypochlorite 5.25% DRUG

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.

Also known as: NaOCl

Sodium Hypochlorite

Propolis 20% DRUG

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

Also known as: Bee glue

Propolis

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

Dow International Dental College

Karachi, Sindh, 75500, Pakistan

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Propolis

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Resins, Plant; Biopolymers; Polymers; Macromolecular Substances; Plant Exudates; Biological Products; Complex Mixtures

Study Officials

• Tayyaba Tahira, BDS FCPS

  Dow International Dental College, Dow University of Health Sciences

  PRINCIPAL INVESTIGATOR

• Farah Naz, BDS FCPS

  Dow International Dental College, Dow University of Health Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

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

Study Record Dates

• First Submitted: July 16, 2023
• First Posted: August 3, 2023
• Study Start: April 1, 2023
• Primary Completion: August 15, 2023
• Study Completion: August 15, 2023
• Last Updated: September 7, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)