Evaluation of Antibiotic Administration Following Tooth Extraction

Evaluation of Necessity of Antibiotic Administration Following Tooth Extraction: A Randomized Control Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Tooth Extraction
• Intervention / Treatment: Drug: 625 mg of amoxicillin with combined clavulanic acid tablet

Detailed Description

Antibiotics are commonly prescribed in dentistry as a prophylactic measure, particularly following tooth extraction which are overused and misused in dental practice, leading to a rise in antimicrobial resistance. By randomly assigning 152 dental patients aged between 18 to 50 years, this trial aims to evaluate the outcomes such as infection rates, healing times, pain and adverse effects of patients receiving antibiotics after tooth extraction versus those who do not. The study will be conducted at the Oral and Maxillofacial Surgery Department, Dental Unit, Chittagong Medical College.

Tooth extractions will be performed under aseptic conditions, followed by standard post-operative care. The intervention group will receive 625 mg amoxicillin with clavulanic acid three times daily for 7 days post-extraction, while the control group will not receive any antibiotic. Both groups will receive 400 mg ibuprofen and 20 mg omeprazole twice daily. Surgeons, patients and assessors will be blinded to group assignments, with a third party managing medication distribution. Clinical evaluations will occur on the 3rd, 7th, and 14th days post-extraction. The Landry wound healing index will be used to assess tissue healing and pain will be recorded using a visual analogue scale. Surgical Site Infection will be diagnosed based on specific clinical criteria. Any Adverse reactions will be monitored. Rescue Additional analgesia and antibiotics will be provided as needed.

Data analysis will be done using the χ²-test, t-tests and logistic regression, with a significance level of 5%. Ethical considerations include obtaining informed consent from all participants. An independent expert team will conduct safety monitoring to manage any adverse events. The results of this study could provide valuable insights for future clinical protocols in dental surgery and contribute to the broader public health goal of reducing unnecessary antibiotic use.

• Study Type: Interventional
• Enrollment (Estimated): 152
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Md Salim Uddin, BDS, MPhil; Phone Number: +8801817754980; Email: salim.bdscmc@gmail.com
• Study Contact Backup: Name: Manjur-E -Mahmud, BDS,FCPS; Phone Number: +8801716-409228; Email: manjuddc36@gmail.com

Study Locations

• Bangladesh
  • Chittagong, Bangladesh
    • Chittagong Medical College
    • Contact: Md Salim Uddin, BDS, MPhil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Patient indicated extraction of teeth
2. Provide informed written consent
3. Patients aged between 18 to 50 years

Exclusion Criteria:

1. The tooth with abscess, infected cyst and tumors that require extensive surgery including impacted teeth
2. Patients who have taken antibiotics before 5 days for any reason will be excluded
3. 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.
4. Female patients who are pregnant or lactating
5. Those women during the menstruation period (disturbed fibrinolytic activity),
6. Participants who are known hypersensitive to the given drugs used in this study
7. Participants who have known resistance to intervention drugs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group-A: Administration of a specific antibiotic regimen post-extraction.; 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; 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.; Other Names: Tablet. Bioclavid 625 mg
No Intervention: Control Group-B: Administration of no antibiotic.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healing time	The Landry wound healing index will be used to assess the tissue healing process at the surgical sites. The assessment will involve evaluating specific parameters such as tissue color, bleeding response to palpation, the presence of granulation tissue, the characteristics of the incision margins, and the presence of suppuration on the 3rd, 7th, and 14th days after the operation. The index classifies the healing pattern based on the color of the soft tissue (pink or red), the presence or absence of suppuration, the amount of bleeding, the presence of granulation tissue, and the exposure of connective tissue into five different categories: (1) very poor, (2) poor, (3) good, (4) very good, and (5) excellent	3rd, 7th, and 14th post-extraction day
Pain perception	Pain perception of the patients will be measured using a visual analogue scale (VAS) ranging from 0 (no pain) to 10 (excessive pain) on the follow-up days	3rd, 7th, and 14th post-extraction day
Adverse reaction	We also evaluate adverse reactions related to the use of antibiotics, defined as follows: 1) Allergic reaction: urticaria and/or angioedema, 2) Anaphylaxis: throat or tongue swelling and/or respiratory symptoms. 3) Gastrointestinal reactions: nausea, vomiting, abdominal pain and diarrhea	3rd, 7th, and 14th post-extraction day

Collaborators and Investigators

• Sponsor: Chittagong Medical College
• Investigators: Principal Investigator: Md Salim Uddin, BDS, MPhil, Chittagong Medical College

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): August 30, 2025
• Study Completion (Estimated): October 15, 2025

Study Registration Dates

• First Submitted: July 7, 2024
• First Submitted That Met QC Criteria: July 13, 2024
• First Posted (Actual): July 16, 2024

Study Record Updates

• Last Update Posted (Actual): July 16, 2024
• Last Update Submitted That Met QC Criteria: July 13, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Antibiotic, tooth extraction, RCT
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; beta-Lactamase Inhibitors; Amoxicillin; Clavulanic Acid; Clavulanic Acids
• Other Study ID Numbers: 59.27.0000.013.19.PG.2024/324

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study protocol will be available
• IPD Sharing Time Frame: August 15, 2025 to August 30, 2025
• IPD Sharing Access Criteria: Researchers interested
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No