A Phase 3 interventional study of Sodium hypochlorite 5.25% and Propolis 20% in Post-operative Pain and Symptomatic Irreversible Pulpitis, sponsored by Dow University of Health Sciences. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-07.
Sponsored by Dow University of Health Sciences · Phase 3, Interventional, and Prevention
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:
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.
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.
302 studies on the registry are indexed under Pulpitis; 67 are open to participants now.
This study's enrollment of 44 is below the median of 62 across 275 interventional studies indexed under Pulpitis.
Browse Pulpitis studies →Dow University of Health Sciences is the lead sponsor of 170 studies on the registry; 30 are open to participants now.
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Exclusion Criteria:
5.25% sodium hypochlorite is the gold standard endodontic irrigant. Other Name: NaOCl
Drug: Sodium hypochlorite 5.25%
Hydroalcoholic 20% propolis will be used as an endodontic irrigant. Other Name: Bee glue
Drug: Propolis 20%
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
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
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
Time frame: 24 hours, 48 hours and 72 hours
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
Time frame: within first 24 hours
Plan to share: No — 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
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Dow University of Health Sciences