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Effect of Preoperative Clindamycin on Postoperative Endodontic Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Nermeen Saeed Abdel Ghany El Sedawy, 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.

Condition or disease Intervention/treatment Phase
Symptomatic Periapical Periodontitis Drug: 600 mg Clindamycin orally Drug: Oral Placebo Phase 2 Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: Clindamycin
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

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Swelling [ Time Frame: 7 days ]
    The occurrence of Swelling will be measured by a questionnaire

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03033472

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Contact: Nermeen SA El Sedawy, Post Graduate 01002463414

Sponsors and Collaborators
Cairo University
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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
Publications of Results:
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Responsible Party: Nermeen Saeed Abdel Ghany El Sedawy, principal Investigator, Cairo University Identifier: NCT03033472    
Other Study ID Numbers: CEBC-CU-2017-01-09
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: January 27, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Periapical Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Periapical Diseases
Jaw Diseases
Clindamycin palmitate
Clindamycin phosphate
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action