Effect of Preoperative Clindamycin on Postoperative Endodontic Pain

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

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03033472

Enrollment

Registered

2017-01-26

Start date

Unknown

Completion date

Unknown

Last updated

2017-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Symptomatic Periapical Periodontitis

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

Interventions

DRUG600 mg Clindamycin orally

600 mg Clindamycin orally 30 minutes before treatment

DRUGOral Placebo

Oral Placebo 30 minutes before treatment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Swelling	7 days	The occurrence of Swelling will be measured by a questionnaire

Contacts

Primary ContactNermeen SA El Sedawy, Post Graduate

nermeen.elsedaway@hotmail.com01002463414

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026