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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Oral tablet 1000 mg of Amoxicillin/ clavulanic acid combination every 12 hours for five days. |
|
| control group | Placebo Comparator | Oral tablet placebo every 12 hours for five days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amoxicillin/Clavulanate Potassium 875 mg-125 mg oral tablet | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative pain. | Post-operative 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. | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed Gomaa, Postgraduate | Contact | 01006610083 | ahmed.eltoukhy@dentistry.cu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Ahmed Gomaa, Postgraduate | Cairo University | Principal Investigator |
| khaled Ezzat, Professor | Cairo University | Study Chair |
| Suzan AW Amin, PhD |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11491635 | Background | 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. | |
| 8734709 | Background | 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. |
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| ID | Term |
|---|---|
| D010485 | Periapical Periodontitis |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D010483 | Periapical Diseases |
| D007571 | Jaw Diseases |
| D009057 | Stomatognathic Diseases |
| D010510 | Periodontal Diseases |
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| ID | Term |
|---|---|
| D000658 | Amoxicillin |
| D019818 | Clavulanic Acid |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 |
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| Drug |
|
| Cairo University |
| Study Director |
| 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. |
| 26946211 | Background | 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. |
| D009059 |
| Mouth Diseases |
| D010518 | Periodontitis |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| 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 |