Effect of Preoperative Clindamycin on Postoperative Endodontic Pain
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|ClinicalTrials.gov Identifier: NCT03033472|
Recruitment Status : Unknown
Verified January 2017 by Nermeen Saeed Abdel Ghany El Sedawy, Cairo University.
Recruitment status was: Not yet recruiting
First Posted : January 26, 2017
Last Update Posted : January 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Symptomatic Periapical Periodontitis||Drug: 600 mg Clindamycin orally Drug: Oral Placebo||Phase 2 Phase 3|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment|
|Official Title:||Effect of Preoperative Single-dose Clindamycin on Postoperative Endodontic Pain in Patients With Symptomatic Apical Periodontitis: A Randomized Controlled Trial|
|Estimated Primary Completion Date :||December 2017|
600 mg of Clindamycin orally 30 minutes before root canal treatment
Drug: 600 mg Clindamycin orally
600 mg Clindamycin orally 30 minutes before treatment
Placebo Comparator: Placebo
placebo 30 minutes Orally before treatment
Drug: Oral Placebo
Oral Placebo 30 minutes before treatment
- Post-operative pain [ Time Frame: Up to 7 days after endodontic treatment ]Post-operative pain will be measured by a numerical rating scale (NRS)
- Swelling [ Time Frame: 7 days ]The occurrence of Swelling will be measured by a questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03033472
|Contact: Nermeen SA El Sedawy, Post Graduateemail@example.com|
|Principal Investigator:||Nermeen SA El Sedawy, Post Graduate||Cairo University|
|Study Chair:||Suzan AW Wanees, PhD||Cairo Univertsity|
|Study Director:||Shaimaa Gawdat, PhD||Cairo University|