Phase 3
N=80
Role of Propolis Paste in Preventing Pain After Root Canal Treatment.
Pain, Postoperative
Bottom Line
View on ClinicalTrials.gov: NCT03723980 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Pain Intensity Measure: Visual Analogue Pain Scale — 11.8; 8.8; 9.4; 10.3 score on a scale — p=0.329
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Propolis (Drug); Calcium Hydroxide (Drug)
- Age
- Adult · 20+ yrs
- Sex
- All
- Sponsor
- Juzer Shabbir Saifee
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Intensity Measure: Visual Analogue Pain Scale |
11.8; 8.8; 9.4; 10.3; 3.5; 5.1 | 0.329 |
| SECONDARY Acute Increase in Pain Score (Acute Exacerbation of Pain) |
4; 1; 29; 34; 0; 4 | — |
| SECONDARY Difference of Pain Score Between Different Time Intervals |
2.97; 11.80; 2.33; -1.54; 5.88; 5.23 | 0.334 |
Summary
This study evaluates the role of propolis paste as compared to calcium hydroxide (when used as intracanal medication) in prevention and treatment of pain after root canal treatment in necrotic (infected) teeth. Half of the participants will receive calcium hydroxide, while the other half will receive propolis.
Eligibility Criteria
Inclusion Criteria
- Single rooted Necrotic teeth with symptomatic or asymptomatic periapical periodontitis having periapical widening or radiolucency without bone expansion (PAI index 2, 3 and 4).
- Teeth with favorable root morphology.
- Teeth with closed apex.
Exclusion Criteria
- Teeth with PAI index 1 and 5.
- Patients who are on antibiotics.
- Patient with recent trauma to the jaw.
- Teeth with open apex
- Multi-rooted teeth.
- Vital teeth.
- Non-restorable teeth.
- Unfavorable root morphology (severely curved, dilacerated, severely sclerosed or obliterated).
- Teeth associated with soft tissue abscess or swelling.
- Teeth with external or internal root resorption
- Re-treatment cases.
- Periodontally compromised teeth (like mobile teeth and teeth with excessive bone loss).
- Teeth requiring endodontic surgery.
- Teeth requiring non-surgical endodontic treatment of multiple teeth in the same or opposing quadrant.
- Medically compromised patients (ASA-III and above), patients with special communication needs or who doesn't understand Urdu or English language.
- Patients allergic to bee pollen or honey products.
Data sourced from ClinicalTrials.gov (NCT03723980). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.