Effect of Amoxicillin/Clavulanic Acid Combination on Postoperative Endodontic Pain

Symptomatic Periapical Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03007342
• Other study ID #: CEBC-CU-2016-11-168
• Status: Not yet recruiting
• Phase: N/A
• First received: December 19, 2016
• Last updated: December 29, 2016
• Start date: January 2017

Study information

• Verified date: December 2016
• Source: Cairo University
• Contact: Ahmed Gomaa, Postgraduate
• Phone: 01006610083
• Email: ahmed.eltoukhy[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 78
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Periapical Periodontitis
• Periodontitis
• Symptomatic Periapical Periodontitis

Intervention

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

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (4)

Arteagoitia MI, Barbier L, Santamaría J, Santamaría 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. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative pain.	Post-operative pain will be measured by a numerical rating scale (NRS).	Up to 7 days after endodontic treatment	No
Secondary	Swelling	The occurrence of Swelling will be measured by a questionnaire.	7 days	No