Effect of Preoperative Clindamycin on Postoperative Endodontic Pain

Cairo University (CU)

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Symptomatic Periapical Periodontitis

Treatments: Drug: 600 mg Clindamycin orally; Drug: Oral Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03033472

CEBC-CU-2017-01-09

Details and patient eligibility

About

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 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

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 2 patient groups, including a placebo group

Clindamycin

Experimental group

Description:

600 mg of Clindamycin orally 30 minutes before root canal treatment

Treatment:

Drug: 600 mg Clindamycin orally

Placebo

Placebo Comparator group

Description:

placebo 30 minutes Orally before treatment

Treatment:

Drug: Oral Placebo