Effect of Preoperative Clindamycin on Postoperative Endodontic Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Effect of Preoperative Single-dose Clindamycin on Postoperative Endodontic Pain in Patients With Symptomatic Apical Periodontitis: A Randomized Controlled Trial

Conditions
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Symptomatic Periapical Periodontitis

Intervention / Treatment
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* Drug: 600 mg Clindamycin orally
* Drug: Oral Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with symptomatic apical periodontitis and do not have evidence of spreading infection or systemic involvement. Mandibular posterior teeth. Patients in good health. Patients who can understand pain scales (NRS). Patients able to sign informed consent. Exclusion Criteria: Patients who have draining sinus tract. Retreatment cases Patients with weeping canals.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clindamycin<br>600 mg of Clindamycin orally 30 minutes before root canal treatment | Drug: 600 mg Clindamycin orally<br>* 600 mg Clindamycin orally 30 minutes before treatment<br>|
| Placebo Comparator: Placebo<br>placebo 30 minutes Orally before treatment | Drug: Oral Placebo<br>* Oral Placebo 30 minutes before treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Swelling | The occurrence of Swelling will be measured by a questionnaire | 7 days |