Effect of Amoxicillin/Clavulanic Acid Combination on Postoperative Endodontic Pain
NCT ID: NCT03007342
Last Updated: 2017-01-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
78 participants
INTERVENTIONAL
2017-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Experimental group
Oral tablet 1000 mg of Amoxicillin/ clavulanic acid combination every 12 hours for five days.
Amoxicillin/Clavulanate Potassium 875 mg-125 mg oral tablet
control group
Oral tablet placebo every 12 hours for five days.
Placebo
Interventions
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Amoxicillin/Clavulanate Potassium 875 mg-125 mg oral tablet
Placebo
Eligibility Criteria
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Inclusion Criteria
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
2. Patients who have a draining sinus tract.
3. Retreatment cases.
18 Years
60 Years
ALL
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Ahmed Gomaa
Post-graduate candidate
Principal Investigators
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Ahmed Gomaa, Postgraduate
Role: PRINCIPAL_INVESTIGATOR
Cairo University
khaled Ezzat, Professor
Role: STUDY_CHAIR
Cairo University
Suzan AW Amin, PhD
Role: STUDY_DIRECTOR
Cairo University
Central Contacts
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References
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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.
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.
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.
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.
Other Identifiers
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CEBC-CU-2016-11-168
Identifier Type: -
Identifier Source: org_study_id
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