Effect of Preoperative Amoxicillin/Clavulanic Acid Combination on Postoperative Endodontic Pain
NCT ID: NCT03033147
Last Updated: 2021-06-18
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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COMPLETED
NA
72 participants
INTERVENTIONAL
2019-10-18
2020-03-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Amoxicillin/Clavulanate Potassium
Amoxicillin/Clavulanate Potassium 875 mg-125 mg orally 30 minutes before root canal treatment
Amoxicillin/Clavulanate Potassium 875 mg-125 mg oral tablet
2 gm of amoxicillin/ clavulanic acid combination orally 30 minutes before root canal treatment
Placebo
placebo 30 minutes before root canal treatment
Oral placebo
placebo 30 minutes before root canal treatment
Interventions
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Amoxicillin/Clavulanate Potassium 875 mg-125 mg oral tablet
2 gm of amoxicillin/ clavulanic acid combination orally 30 minutes before root canal treatment
Oral placebo
placebo 30 minutes before root canal treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Mandibular posterior teeth.
* Patients with non-contributory systemic condition.
* Patients who can understand pain scales and able to sign informed consent.
Exclusion Criteria
* Patients who have a draining sinus tract.
* Retreatment cases.
18 Years
60 Years
ALL
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Nermeen Naser Taleb Moushtaha
Principal Investigator
Principal Investigators
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Nermeen NT Moushtaha, Postgraduate
Role: PRINCIPAL_INVESTIGATOR
Cairo University
Suzan AW Amin, PhD
Role: STUDY_CHAIR
Cairo University
Shaimaa Gawdat, PhD
Role: STUDY_DIRECTOR
Cairo University
Locations
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Cairo University Faculty of Dentistry
Cairo, , Egypt
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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CEBC-CU-2016-12-163
Identifier Type: -
Identifier Source: org_study_id
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