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Preoperative Dose of Co-amoxiclav for Prevention of Postoperative Complications in Dentoalveolar Surgery

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03844776
Recruitment Status : Recruiting
First Posted : February 18, 2019
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Giath Gazal, Taibah University

Brief Summary:
There was no evidence to judge the effects of preventative antibiotics for extractions of severely decayed teeth, teeth in diseased gums, or extractions in patients who are sick or have low immunity to infection. Undertaking research in these groups of people may not be possible or ethical. However, it is likely that in situations where patients are at a higher risk of infection that preventative antibiotics may be beneficial, because infections in this group are likely to be more frequent and more difficult to treat To the best of knowledge, no adult study has compared the effects of single dose of Co-Amoxiclave and full oral course before or after dentoalveolar surgery. The current study has formally considered this comparison as a potential valuable trail for reducing the postoperative complications in adult patients who have had surgical removal of teeth under LA.

Condition or disease Intervention/treatment Phase
Infection Drug: Co-Amoxiclav Drug: Paracetamol Drug: Chlorhexidine mouthwash Drug: Normal saline Drug: Amoxicillin 500 Mg Drug: Metronidazole Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:
  • Treatment 1: 0.9% normal saline irrigation immediately after the surgery with course of Amoxicillin 500 mg following the surgery for 5 days (control group)
  • Treatment 2: 625 mg Co-Amoxiclav and 1g paracetamol preoperatively and 0.2% chlorhexidine mouthwash immediately before the surgery but there is no additional course of antibiotic following the surgery.
  • Treatment 3: 0.9% normal saline irrigation immediately after the surgery with course of antibiotic Co-Amoxiclav for five days postoperatively
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Comparison of Single Preoperative Dose of Co-amoxiclav Versus Postoperative Full Course of Amoxicillin/ Co-amoxiclav in Prevention of Postoperative Complications in Dentoalveolar Surgery: a Randomized Controlled Trial
Actual Study Start Date : October 2, 2019
Estimated Primary Completion Date : March 2, 2020
Estimated Study Completion Date : June 2, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery
Drug Information available for: Amoxicillin

Arm Intervention/treatment
Active Comparator: Co-Amoxiclav postoperatively alone
• Treatment 1: 0.9% normal saline irrigation immediately after the surgery with course of Co-Amoxiclav 625 mg 0.2% chlorhexidine mouthwash following the surgery for 5 days (control group)
Drug: Co-Amoxiclav
amoxicillin + clavulanic acid orally

Drug: Chlorhexidine mouthwash
0.2% chlorhexidine mouthwash

Drug: Normal saline
0.9% normal saline irrigation

Active Comparator: Co-Amoxiclav preoperatively with Metronidazole postoperatively
• Treatment 2: 625 mg Co-Amoxiclav and 1g Paracetamol preoperatively and 0.2% chlorhexidine mouthwash immediately before the surgery with course of Metronidazole 500 mg and 0.2% chlorhexidine mouthwash following the surgery for 5 days
Drug: Co-Amoxiclav
amoxicillin + clavulanic acid orally

Drug: Paracetamol
paracetamol orally

Drug: Chlorhexidine mouthwash
0.2% chlorhexidine mouthwash

Drug: Normal saline
0.9% normal saline irrigation

Drug: Metronidazole
metronidazole 500 mg orally

Active Comparator: Co-Amoxiclav preoperatively with amoxicillin postoperatively
• Treatment 3: 625 mg Co-Amoxiclav and 1g Paracetamol preoperatively and 0.2% chlorhexidine mouthwash immediately before the surgery with course of amoxicillin 500 mg and 0.2% chlorhexidine mouthwash following the surgery for 5 days
Drug: Co-Amoxiclav
amoxicillin + clavulanic acid orally

Drug: Paracetamol
paracetamol orally

Drug: Chlorhexidine mouthwash
0.2% chlorhexidine mouthwash

Drug: Normal saline
0.9% normal saline irrigation

Drug: Amoxicillin 500 Mg
Amoxicillin 500 orally




Primary Outcome Measures :
  1. infection rate [ Time Frame: 5 days after extraction assessment ]
    dry socket after surgical extraction



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patient age from 16 to 70 yrs old
  • Patient needs surgical teeth extraction (subject tooth will be removed using osteotomy by motorised drill).

Exclusion Criteria:

  • Patients refusing the preoperative dose of oral co-amoxiclav, and unwilling to take part .
  • Patients who are allergic to co-amoxiclve, amoxicillin or metronidazole
  • Patient are on warfarin medication

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): NCT03844776


Contacts
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Contact: Giath Gazal 00966532158597 gazal73@yahoo.co.uk

Locations
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Saudi Arabia
Taibah University Recruiting
Medina, Saudi Arabia, 41311
Contact: Giath Gazal, PhD         
Sponsors and Collaborators
Taibah University

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Responsible Party: Giath Gazal, Associate Professor, Taibah University
ClinicalTrials.gov Identifier: NCT03844776    
Other Study ID Numbers: IORG0008371
First Posted: February 18, 2019    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Giath Gazal, Taibah University:
dry socket
bleeding
swelling
Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes
Acetaminophen
Amoxicillin
Metronidazole
Amoxicillin-Potassium Clavulanate Combination
Chlorhexidine
Chlorhexidine gluconate
Anti-Bacterial Agents
Anti-Infective Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Infective Agents, Local
Disinfectants
Dermatologic Agents
Antiprotozoal Agents
Antiparasitic Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action