Effect of Preoperative Clindamycin on Postoperative Endodontic Pain

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2017

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

Interventions

  • Drug: 600 mg Clindamycin orally
    • 600 mg Clindamycin orally 30 minutes before treatment
  • Drug: Oral Placebo
    • Oral Placebo 30 minutes before treatment

Arms, Groups and Cohorts

  • Experimental: Clindamycin
    • 600 mg of Clindamycin orally 30 minutes before root canal treatment
  • Placebo Comparator: Placebo
    • placebo 30 minutes Orally before treatment

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Swelling
    • Time Frame: 7 days
    • The occurrence of Swelling will be measured by a questionnaire

Participating in This Clinical Trial

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. Exclusion Criteria:

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cairo University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Nermeen Saeed Abdel Ghany El Sedawy, principal Investigator – Cairo University
  • Overall Official(s)
    • Nermeen SA El Sedawy, Post Graduate, Principal Investigator, Cairo University
    • Suzan AW Wanees, PhD, Study Chair, Cairo Univertsity
    • Shaimaa Gawdat, PhD, Study Director, Cairo University
  • Overall Contact(s)
    • Nermeen SA El Sedawy, Post Graduate, 01002463414, nermeen.elsedaway@hotmail.com

Citations Reporting on Results

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.

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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