Evaluation of Antibiotic Administration Following Tooth Extraction

NCT06502288 | Not Yet Recruiting DMC

• 1 other identifier: 59.27.0000.013.19.PG.2024/324
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

The trial aims to evaluate the effects of prescribing antibiotics after tooth extraction. 152 dental patients aged 18 to 50 will be randomly assigned. The study will assess infection rates, healing times, pain, and adverse effects in patients who receive antibiotics versus those who do not. The trial will be conducted at the Oral and Maxillofacial Surgery Department, Dental Unit, Chittagong Medical College. Data analysis will involve the use of the χ²-test, t-tests, and logistic regression, with a significance level of 5%. Ethical considerations include obtaining informed consent from all participants, and safety will be monitored by an independent expert team.

Conditions

Tooth Extraction

Keywords

Antibiotic, tooth extraction, RCT

Outcome Measures

Primary Outcomes (1)

• Incidence of post-extraction infections

  Surgical site infection will be diagnosed if the patient presents at least one of the following: A: Purulent drainage from the surgical wound or abscess. B: Isolation of pathogenic microorganisms in liquid or tissue cultures from the surgical site. C: Spontaneous opening of the incision site in patients with at least one of the following signs or symptoms: 1) fever (\>38°C), 2) pain from palpation or spontaneous, 3) localized swelling, facial erythema or local heat. D: Severe pain after a week, together with moderate or severe inflammation or redness in the mouth and/or moderate or severe intraoral redness with no other apparent cause, that improves with antibiotic treatment.

  3rd, 7th, and 14th post-extraction day

Secondary Outcomes (3)

• Healing time

  3rd, 7th, and 14th post-extraction day

• Pain perception

  3rd, 7th, and 14th post-extraction day

• Adverse reaction

  3rd, 7th, and 14th post-extraction day

Study Arms (2)

Intervention Group-A: Administration of a specific antibiotic regimen post-extraction.

EXPERIMENTAL

Patients will be prescribed 625 mg of amoxicillin with combined clavulanic acid tablets three times a day after meals for 7 days following extraction and also a non-steroidal anti-inflammatory drug, 400 mg ibuprofen, and an H2 receptor blocker, 20 mg omeprazole, twice daily before meals.

Drug: 625 mg of amoxicillin with combined clavulanic acid tablet

Control Group-B: Administration of no antibiotic.

NO INTERVENTION

No post-operative antibiotics will be administered, patients will be prescribed a non-steroidal anti-inflammatory drug, 400 mg ibuprofen, and an H2 receptor blocker, 20 mg omeprazole, twice daily before meals.

Interventions

625 mg of amoxicillin with combined clavulanic acid tablet DRUG

The intervention group must take 625 mg of amoxicillin with combined clavulanic acid tablets three times a day after meals for 7 days following extraction.

Also known as: Tablet. Bioclavid 625 mg

Intervention Group-A: Administration of a specific antibiotic regimen post-extraction.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patient indicated extraction of teeth
• Provide informed written consent
• Patients aged between 18 to 50 years

You may not qualify if:

• The tooth with abscess, infected cyst and tumors that require extensive surgery including impacted teeth
• Patients who have taken antibiotics before 5 days for any reason will be excluded
• Patients who are medically compromised such as DM, Congenital cyanotic heart disease, chronic kidney disease (CKD), Patients with chemotherapy or radiotherapy, Chronic Liver Disease (CLD), etc.
• Female patients who are pregnant or lactating
• Those women during the menstruation period (disturbed fibrinolytic activity),
• Participants who are known hypersensitive to the given drugs used in this study
• Participants who have known resistance to intervention drugs

Sponsors & Collaborators

• Chittagong Medical College: lead

Study Sites (1)

Chittagong Medical College

Chittagong, Bangladesh

Location

MeSH Terms

Interventions

Amoxicillin

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Md Salim Uddin, BDS, MPhil

  Chittagong Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Md Salim Uddin, BDS, MPhil

CONTACT

+8801817754980; salim.bdscmc@gmail.com

Manjur-E -Mahmud, BDS,FCPS

CONTACT

+8801716-409228; manjuddc36@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The surgeon, patients and the outcome assessor will be blind for the duration of the study. Participants: After teeth extraction, participants receive either the antibiotic or not without knowing which one they take. Surgeon: The clinicians who prescribe and administer the medication will not know whether they are giving the antibiotic or not. This can be achieved by having a third-party individual prescribe and distribute the medications according to the randomization schedule. Outcome Assessor: The individual assessing the outcomes (e.g., infection rates, healing times) will also be blinded to which treatment the participant received. This prevents bias in the evaluation of the treatment effects.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, Children Dentistry

Model Details: Intervention Group-A: Administration of a specific antibiotic regimen post-extraction. Control Group-B: Administration of no antibiotic. For group A, patients will be prescribed 625 mg of amoxicillin with combined clavulanic acid tablets three times a day after meals for 7 days following extraction. For group B, no post-operative antibiotics will be administered. Both groups will be given a non-steroidal anti-inflammatory drug, 400 mg ibuprofen, and an H2 receptor blocker, 20 mg omeprazole, twice daily before meals.

Study Record Dates

• First Submitted: July 7, 2024
• First Posted: July 16, 2024
• Study Start: January 1, 2025
• Primary Completion: August 30, 2025
• Study Completion: October 15, 2025
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: August 15, 2025 to August 30, 2025
• Access Criteria: Researchers interested

Locations

BA (1)