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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sodium Hypochlorite | Active Comparator | 5.25% sodium hypochlorite is the gold standard endodontic irrigant. Other Name: NaOCl |
|
| Propolis | Experimental | Hydroalcoholic 20% propolis will be used as an endodontic irrigant. Other Name: Bee glue |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | within first 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dow International Dental College | Karachi | Sindh | 75500 | Pakistan |
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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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D011429 | Propolis |
| ID | Term |
|---|---|
| D012116 | Resins, Plant |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
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2 interventional groups assigned. 1 will be receiving routine intervention and other is the experimental group.
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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.
|
|
| Propolis 20% | Drug | In group B, a 20% hydroalcoholic propolis solution of 3 milliliters will be used to irrigate each canal, between each instrument. |
|
|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D053147 |
| Plant Exudates |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |