Clinical trial NCT03033147: Effect of Preoperative Amoxicillin/Clavulanic Acid Combination on Postoperative Endodontic Pain
Official title: Effect of Preoperative, Single-dose Amoxicillin/Clavulanic Acid Combination on Postoperative Endodontic Pain in Patients With Symptomatic Apical Periodontitis: A Double-Blind Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Symptomatic Periapical Periodontitis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-01-26
Enrollment: 72
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 a single preoperative dose 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative pain
timeFrame: Up to 7 days after endodontic treatment
Secondary outcomes:
measure: Swelling
timeFrame: Up to 7 days after endodontic treatment
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University Faculty of Dentistry
Study officials:
affiliation: Cairo University
name: Nermeen NT Moushtaha, Postgraduate
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Suzan AW Amin, PhD
role: STUDY_CHAIR
affiliation: Cairo University
name: Shaimaa Gawdat, PhD
role: STUDY_DIRECTOR
References:
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: Akbar I. Efficacy of Prophylactic use of Antibiotics to Avoid Flare up During Root Canal Treatment of Nonvital Teeth: A Randomized Clinical Trial. J Clin Diagn Res. 2015 Mar;9(3):ZC08-11. doi: 10.7860/JCDR/2015/12046.5620. Epub 2015 Mar 1.
citation: Contardo L, Meneguzzi E, Cadenaro M, Di Lenarda R. Clinical evaluation of antibiotic prophylaxis before endodontic treatment of necrotic teeth. Minerva Stomatol. 2005 Mar;54(3):153-60. English, Italian.
citation: Pickenpaugh L, Reader A, Beck M, Meyers WJ, Peterson LJ. Effect of prophylactic amoxicillin on endodontic flare-up in asymptomatic, necrotic teeth. J Endod. 2001 Jan;27(1):53-6. doi: 10.1097/00004770-200101000-00019.