Role of Propolis Endodontic Irrigant on Post-Operative Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2023-08-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Post-operative Pain Symptomatic Irreversible Pulpitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

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Sodium Hypochlorite

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

Group Type ACTIVE_COMPARATOR

Sodium hypochlorite 5.25%

Intervention Type 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.

Propolis

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

Group Type EXPERIMENTAL

Propolis 20%

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Propolis 20%

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

Intervention Type DRUG

Other Intervention Names

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NaOCl Bee glue

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes