An interventional study of Amoxicillin/Clavulanate Potassium 875 mg-125 mg oral tablet and Placebo in Symptomatic Periapical Periodontitis, sponsored by Cairo University. Status unknown. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2017-01-02.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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.
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.
1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.
This study's planned enrollment of 78 is above the median of 45 across 1,191 interventional studies indexed under Periodontitis.
Browse Periodontitis studies →Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
Oral tablet 1000 mg of Amoxicillin/ clavulanic acid combination every 12 hours for five days.
Drug: Amoxicillin/Clavulanate Potassium 875 mg-125 mg oral tablet
Oral tablet placebo every 12 hours for five days.
Drug: Placebo
Post-operative pain.
Post-operative pain will be measured by a numerical rating scale (NRS).
Time frame: Up to 7 days after endodontic treatment
Swelling
The occurrence of Swelling will be measured by a questionnaire.
Time frame: 7 days
No study locations are listed for this record.
Plan to share: No
This study is status unknown, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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Cairo University