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Effect of Preoperative Amoxicillin/Clavulanic Acid Combination on Postoperative Endodontic Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03033147
Recruitment Status : Unknown
Verified January 2017 by Nermeen Naser Taleb Moushtaha, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : January 26, 2017
Last Update Posted : January 26, 2017
Sponsor:
Information provided by (Responsible Party):
Nermeen Naser Taleb Moushtaha, Cairo University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Symptomatic Periapical Periodontitis Drug: Amoxicillin/Clavulanate Potassium 875 mg-125 mg oral tablet Drug: Oral placebo Phase 2 Phase 3

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Preoperative, Single-dose Amoxicillin/Clavulanic Acid Combination on Postoperative Endodontic Pain in Patients With Symptomatic Apical Periodontitis: A Double-Blind Randomized Controlled Trial.
Estimated Primary Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium

Arm Intervention/treatment
Experimental: Amoxicillin/Clavulanate Potassium
Amoxicillin/Clavulanate Potassium 875 mg-125 mg orally 30 minutes before root canal treatment
Drug: Amoxicillin/Clavulanate Potassium 875 mg-125 mg oral tablet
2 gm of amoxicillin/ clavulanic acid combination orally 30 minutes before root canal treatment

Placebo Comparator: Placebo
placebo 30 minutes before root canal treatment
Drug: Oral placebo
placebo 30 minutes before root canal treatment




Primary Outcome Measures :
  1. Postoperative pain [ Time Frame: Up to 7 days after endodontic treatment ]
    Postoperative pain will be measured by a numerical rating scale (NRS).


Secondary Outcome Measures :
  1. Swelling [ Time Frame: Up to 7 days after endodontic treatment ]
    The occurrence of Swelling will be measured by a questionnaire.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with symptomatic apical periodontitis who do not have evidence of spreading infection or systemic involvement.
  • Mandibular posterior teeth.
  • Patients with non-contributory systemic condition.
  • Patients who can understand pain scales and able to sign informed consent.

Exclusion Criteria:

  • Patients allergic to penicillin.
  • Patients who have a draining sinus tract.
  • Retreatment cases.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03033147


Contacts
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Contact: Nermeen NT Moushtaha, Postgraduate +201005487011 nermennaser@hotmail.com

Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Nermeen NT Moushtaha, Postgraduate Cairo University
Study Chair: Suzan AW Amin, PhD Cairo University
Study Director: Shaimaa Gawdat, PhD Cairo University
Publications:
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Responsible Party: Nermeen Naser Taleb Moushtaha, Principal Investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03033147    
Other Study ID Numbers: CEBC-CU-2016-12-163
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: January 26, 2017
Last Verified: January 2017

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Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Periodontitis
Periapical Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Periapical Diseases
Jaw Diseases
Amoxicillin
Clavulanic Acid
Clavulanic Acids
Amoxicillin-Potassium Clavulanate Combination
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action