Clinical trial NCT03007342: Effect of Amoxicillin/Clavulanic Acid Combination on Postoperative Endodontic Pain
Official title: Effect of Amoxicillin/Clavulanic Acid Combination on Postoperative Endodontic Pain in Patients With Symptomatic Apical Periodontitis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Symptomatic Periapical Periodontitis
Keywords: Amoxicillin
clavulanic acid
Periapical periodontitis
Post-operative pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-01-02
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Post-operative pain.
timeFrame: Up to 7 days after endodontic treatment
Secondary outcomes:
measure: Swelling
timeFrame: 7 days
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Ahmed Gomaa, Postgraduate
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: khaled Ezzat, Professor
role: STUDY_CHAIR
affiliation: Cairo University
name: Suzan AW Amin, PhD
role: STUDY_DIRECTOR
References:
citation: Henry M, Reader A, Beck M. Effect of penicillin on postoperative endodontic pain and swelling in symptomatic necrotic teeth. J Endod. 2001 Feb;27(2):117-23. doi: 10.1097/00004770-200102000-00016.
citation: Fouad AF, Rivera EM, Walton RE. Penicillin as a supplement in resolving the localized acute apical abscess. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1996 May;81(5):590-5. doi: 10.1016/s1079-2104(96)80054-0.
citation: Cope A, Francis N, Wood F, Mann MK, Chestnutt IG. Systemic antibiotics for symptomatic apical periodontitis and acute apical abscess in adults. Cochrane Database Syst Rev. 2014 Jun 26;(6):CD010136. doi: 10.1002/14651858.CD010136.pub2.
citation: Arteagoitia MI, Barbier L, Santamaria J, Santamaria G, Ramos E. Efficacy of amoxicillin and amoxicillin/clavulanic acid in the prevention of infection and dry socket after third molar extraction. A systematic review and meta-analysis. Med Oral Patol Oral Cir Bucal. 2016 Jul 1;21(4):e494-504. doi: 10.4317/medoral.21139.