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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amoxicillin/Clavulanate Potassium | Experimental | Amoxicillin/Clavulanate Potassium 875 mg-125 mg orally 30 minutes before root canal treatment |
|
| Placebo | Placebo Comparator | placebo 30 minutes before root canal treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amoxicillin/Clavulanate Potassium 875 mg-125 mg oral tablet | Drug | 2 gm of amoxicillin/ clavulanic acid combination orally 30 minutes before root canal treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain | Postoperative pain will be measured by a numerical rating scale (NRS). | Up to 7 days after endodontic treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Swelling | The occurrence of Swelling will be measured by a questionnaire. | Up to 7 days after endodontic treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nermeen NT Moushtaha, Postgraduate | Cairo University | Principal Investigator |
| Suzan AW Amin, PhD | Cairo University | Study Chair |
| Shaimaa Gawdat, PhD | Cairo University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University Faculty of Dentistry | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24967571 | Background | 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. | |
| 25954695 | Background | 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. |
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| ID | Term |
|---|---|
| D000658 | Amoxicillin |
| D019818 | Clavulanic Acid |
| D019980 | Amoxicillin-Potassium Clavulanate Combination |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 |
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|
| Oral placebo | Drug | placebo 30 minutes before root canal treatment |
|
| 15920447 | Background | 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. |
| 11487166 | Background | 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. |
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002969 | Clavulanic Acids |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |