Effect of Amoxicillin/Clavulanic Acid Combination on Postoperative Endodontic Pain

Effect of Amoxicillin/Clavulanic Acid Combination on Postoperative Endodontic Pain in Patients With Symptomatic Apical Periodontitis: A Randomized Controlled Trial

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03007342

Enrollment

Registered

2017-01-02

Start date

2017-01-31

Completion date

Unknown

Last updated

2017-01-02

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

Conditions

Symptomatic Periapical Periodontitis

Keywords

Amoxicillin, clavulanic acid, Periapical periodontitis, Post-operative pain

Brief summary

The aim of this prospective, randomized, placebo controlled study is to evaluate the effect of amoxicillin/clavulanic acid combination 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. After single-visit root canal treatment, eligible participants will be randomly assigned to one of the following groups: experimental group (taking oral tablet 1000 mg of Amoxicillin/ clavulanic acid combination) or control group (taking placebo tablet). 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

DRUGAmoxicillin/Clavulanate Potassium 875 mg-125 mg oral tablet

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

1. Patients with symptomatic apical periodontitis who do not have evidence of spreading infection or systemic involvement. 2. Mandibular posterior teeth with positive response to percussion. 3. Patients with non-contributory systemic condition. 4. Patients who can understand pain scales and able to sign informed consent.

Exclusion criteria

1. Patients allergic to penicillin. 2. Patients who have a draining sinus tract. 3. Retreatment cases.

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 ContactAhmed Gomaa, Postgraduate

ahmed.eltoukhy@dentistry.cu.edu.eg01006610083

Outcome results

None listed

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