Effect of Preoperative Amoxicillin/Clavulanic Acid Combination on Postoperative Endodontic Pain

Cairo University (CU)

Status: Completed

Conditions: Symptomatic Periapical Periodontitis

Treatments: Drug: Oral placebo; Drug: Amoxicillin/Clavulanate Potassium 875 mg-125 mg oral tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03033147

CEBC-CU-2016-12-163

Details and patient eligibility

About

The aim of this prospective, randomized, placebo controlled study is to evaluate the effect of a single preoperative dose of amoxicillin/clavulanic acid combination 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.

Prior to initiation of root canal treatment, eligible participants will be randomly assigned to one of the following groups: experimental group (receiving 2 gm of amoxicillin/ clavulanic acid orally 30 minutes before the treatment) or control group (receiving a placebo 30 minutes before treatment).

Root canal treatment will then be carried out in a single visit.

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 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with symptomatic apical periodontitis who do not have evidence of spreading infection or systemic involvement.
• Mandibular posterior teeth.
• Patients with non-contributory systemic condition.
• Patients who can understand pain scales and able to sign informed consent.

Exclusion criteria

• Patients allergic to penicillin.
• Patients who have a draining sinus tract.
• Retreatment cases.

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

Amoxicillin/Clavulanate Potassium

Experimental group

Description:

Amoxicillin/Clavulanate Potassium 875 mg-125 mg orally 30 minutes before root canal treatment

Treatment:

Drug: Amoxicillin/Clavulanate Potassium 875 mg-125 mg oral tablet

Placebo

Placebo Comparator group

Description:

placebo 30 minutes before root canal treatment

Treatment:

Drug: Oral placebo