Effect of Preoperative Clindamycin on Postoperative Endodontic Pain

Phase 2

• Conditions: Symptomatic Periapical Periodontitis
• Interventions: Drug: 600 mg Clindamycin orally; Drug: Oral Placebo

• Registration Number: NCT03033472
• Lead Sponsor: Cairo University

Brief Summary

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

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

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Status Verified: 2017-01
• Study First Submitted: 2017-01-24
• Study First Submitted QC: 2017-01-24
• Study First Posted: 2017-01-26
• Last Update Submitted: 2017-01-26
• Last Update Posted: 2017-01-27
• Primary Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

1. Patients with symptomatic apical periodontitis and do not have evidence of spreading infection or systemic involvement.
2. Mandibular posterior teeth.
3. Patients in good health.
4. Patients who can understand pain scales (NRS).
5. Patients able to sign informed consent.

Read More

Exclusion Criteria

1. Patients who have draining sinus tract.
2. Retreatment cases
3. Patients with weeping canals.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clindamycin	600 mg Clindamycin orally	600 mg of Clindamycin orally 30 minutes before root canal treatment
Placebo	Oral Placebo	placebo 30 minutes Orally before treatment

Primary Outcome Measures

Name	Time	Method
Post-operative pain	Up to 7 days after endodontic treatment	Post-operative pain will be measured by a numerical rating scale (NRS)

Secondary Outcome Measures

Name	Time	Method
Swelling	7 days	The occurrence of Swelling will be measured by a questionnaire