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Role of Propolis Endodontic Irrigant on Post-Operative Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05974748
Recruitment Status : Completed
First Posted : August 3, 2023
Last Update Posted : September 7, 2023
Sponsor:
Information provided by (Responsible Party):
Tayyaba Tahira, Dow University of Health Sciences

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Actual 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.
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 : April 1, 2023
Actual Primary Completion Date : August 15, 2023
Actual Study Completion Date : August 15, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: Bee glue


Outcome Measures
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Primary Outcome Measures :
  1. Change in post-operative pain intensity on visual analogue scale(0-10) [ Time Frame: 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


Secondary Outcome Measures :
  1. Need of rescue medicine in both groups [ Time Frame: within first 24 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
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05974748


Locations
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Pakistan
Dow International Dental College
Karachi, Sindh, Pakistan, 75500
Sponsors and Collaborators
Dow University of Health Sciences
Investigators
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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
More Information
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Responsible Party: Tayyaba Tahira, Lecturer, Dow University of Health Sciences
ClinicalTrials.gov Identifier: NCT05974748    
Other Study ID Numbers: 2908
First Posted: August 3, 2023    Key Record Dates
Last Update Posted: September 7, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

Only investigators and co-investigators of this study will be able to access to participants' personal data.

Ownership of the data will remain with the principal investigator and Department of Operative Dentistry, Dow International Dental College(DIDC) , Dow University of Health Sciences

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tayyaba Tahira, Dow University of Health Sciences:
Propolis
Endodontic Irrigant
Additional relevant MeSH terms:
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Pulpitis
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Dental Pulp Diseases
 Tooth Diseases
Stomatognathic Diseases
Propolis
Sodium Hypochlorite
Eusol
Anti-Infective Agents
Disinfectants