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The aim of this prospective, randomized, placebo controlled study is to evaluate the effect of clindamycin on post-operative pain and swelling in adult patient with symptomatic apical periodontitis.
Medical and dental history will be obtained from all patients participating in this trial. Clinical and radiographic evaluation for each tooth included in this study will be recorded.
Clinical diagnosis of symptomatic apical periodontitis is to be confirmed.
Before root canal treatment, eligible participants will be randomly assigned to one of the following groups: experimental group (taking 600 mg of clindamycin orally) or control group (taking placebo ) 30 minutes before the start of the treatment. Single-visit root canal treatment will be performed.
Each patient will receive a 7-day diary to record postoperative pain and swelling.In case of pain, the participant will be instructed to take an analgesic. Post-operative pain will be measured as a primary outcome on 11-point scale (NRS) at the following time points: 6, 12, 24, 48, 72 hours and 7 days. The occurrence of swelling will be reported by participant as a secondary outcome
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clindamycin | Experimental | 600 mg of Clindamycin orally 30 minutes before root canal treatment |
|
| Placebo | Placebo Comparator | placebo 30 minutes Orally before treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 600 mg Clindamycin orally | Drug | 600 mg Clindamycin orally 30 minutes before treatment |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative pain | Post-operative pain will be measured by a numerical rating scale (NRS) | Up to 7 days after endodontic treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Swelling | The occurrence of Swelling will be measured by a questionnaire | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nermeen SA El Sedawy, Post Graduate | Contact | 01002463414 | nermeen.elsedaway@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Nermeen SA El Sedawy, Post Graduate | Cairo University | Principal Investigator |
| Suzan AW Wanees, PhD | Cairo Univertsity | Study Chair |
| Shaimaa Gawdat, PhD |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24967571 | Result | Cope A, Francis N, Wood F, Mann MK, Chestnutt IG. Systemic antibiotics for symptomatic apical periodontitis and acute apical abscess in adults. Cochrane Database Syst Rev. 2014 Jun 26;(6):CD010136. doi: 10.1002/14651858.CD010136.pub2. | |
| 16343114 | Result | Lindeboom JA, Frenken JW, Valkenburg P, van den Akker HP. The role of preoperative prophylactic antibiotic administration in periapical endodontic surgery: a randomized, prospective double-blind placebo-controlled study. Int Endod J. 2005 Dec;38(12):877-81. doi: 10.1111/j.1365-2591.2005.01030.x. |
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Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
| Oral Placebo |
| Drug |
Oral Placebo 30 minutes before treatment |
|
| Cairo University |
| Study Director |