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

NCT03844776 | Unknown

• 1 other identifier: IORG0008371
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

Infection

Keywords

dry socket; bleeding; swelling

Outcome Measures

Primary Outcomes (1)

• infection rate

  dry socket after surgical extraction

  5 days after extraction assessment

Study Arms (3)

Co-Amoxiclav postoperatively alone

ACTIVE COMPARATOR

• 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; Drug: Chlorhexidine mouthwash; Drug: Normal saline

Co-Amoxiclav preoperatively with Metronidazole postoperatively

ACTIVE COMPARATOR

• 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; Drug: Paracetamol; Drug: Chlorhexidine mouthwash; Drug: Normal saline; Drug: Metronidazole

Co-Amoxiclav preoperatively with amoxicillin postoperatively

ACTIVE COMPARATOR

• 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; Drug: Paracetamol; Drug: Chlorhexidine mouthwash; Drug: Normal saline; Drug: Amoxicillin 500 Mg

Interventions

Co-Amoxiclav DRUG

amoxicillin + clavulanic acid orally

Co-Amoxiclav postoperatively alone; Co-Amoxiclav preoperatively with Metronidazole postoperatively; Co-Amoxiclav preoperatively with amoxicillin postoperatively

Paracetamol DRUG

paracetamol orally

Co-Amoxiclav preoperatively with Metronidazole postoperatively; Co-Amoxiclav preoperatively with amoxicillin postoperatively

Chlorhexidine mouthwash DRUG

0.2% chlorhexidine mouthwash

Co-Amoxiclav postoperatively alone; Co-Amoxiclav preoperatively with Metronidazole postoperatively; Co-Amoxiclav preoperatively with amoxicillin postoperatively

Normal saline DRUG

0.9% normal saline irrigation

Co-Amoxiclav postoperatively alone; Co-Amoxiclav preoperatively with Metronidazole postoperatively; Co-Amoxiclav preoperatively with amoxicillin postoperatively

Amoxicillin 500 Mg DRUG

Amoxicillin 500 orally

Co-Amoxiclav preoperatively with amoxicillin postoperatively

Metronidazole DRUG

metronidazole 500 mg orally

Co-Amoxiclav preoperatively with Metronidazole postoperatively

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taibah University: lead

Study Sites (1)

Taibah University

Madinah, 41311, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Infections; Dry Socket; Hemorrhage

Interventions

Amoxicillin-Potassium Clavulanate Combination; Acetaminophen; Saline Solution; Amoxicillin; Metronidazole

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clavulanic Acid; Clavulanic Acids; beta-Lactams; Lactams; Amides; Organic Chemicals; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Acetanilides; Anilides; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Giath Gazal

CONTACT

00966532158597; gazal73@yahoo.co.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: * 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

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: February 18, 2019
• Study Start: October 2, 2019
• Primary Completion: December 2, 2020
• Study Completion: January 20, 2021
• Last Updated: October 6, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share

Locations

SA (1)