Clinical trial NCT05974748: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post-operative Pain
Symptomatic Irreversible Pulpitis
Keywords: Propolis
Endodontic Irrigant
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2023-08-03
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 interventional groups assigned. 1 will be receiving routine intervention and other is the experimental group.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in post-operative pain intensity on visual analogue scale(0-10)
timeFrame: 24 hours, 48 hours and 72 hours
Secondary outcomes:
measure: Need of rescue medicine in both groups
timeFrame: within first 24 hours
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Dow International Dental College
state: Sindh
Study officials:
affiliation: Dow International Dental College, Dow University of Health Sciences
name: Tayyaba Tahira, BDS FCPS
role: PRINCIPAL_INVESTIGATOR
affiliation: Dow International Dental College, Dow University of Health Sciences
name: Farah Naz, BDS FCPS
role: STUDY_DIRECTOR
References: