Effect of Preoperative Clindamycin on Postoperative Endodontic Pain

January 26, 2017 updated by: Nermeen Saeed Abdel Ghany El Sedawy, Cairo University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

72

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative pain
Time Frame: Up to 7 days after endodontic treatment
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
Time Frame: 7 days
The occurrence of Swelling will be measured by a questionnaire
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Nermeen SA El Sedawy, Post Graduate, Cairo University
  • Study Chair: Suzan AW Wanees, PhD, Cairo Univertsity

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

January 24, 2017

First Submitted That Met QC Criteria

January 24, 2017

First Posted (Estimate)

January 26, 2017

Study Record Updates

Last Update Posted (Estimate)

January 27, 2017

Last Update Submitted That Met QC Criteria

January 26, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEBC-CU-2017-01-09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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