Clinical trial NCT06502288: Evaluation of Antibiotic Administration Following Tooth Extraction
Official title: Evaluation of Necessity of Antibiotic Administration Following Tooth Extraction: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Tooth Extraction
Keywords: Antibiotic, tooth extraction, RCT
Lead sponsor: Chittagong Medical College
Sponsor class: OTHER
First posted: 2024-07-16
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of post-extraction infections
timeFrame: 3rd, 7th, and 14th post-extraction day
Secondary outcomes:
measure: Healing time
timeFrame: 3rd, 7th, and 14th post-extraction day
measure: Pain perception
timeFrame: 3rd, 7th, and 14th post-extraction day
measure: Adverse reaction
timeFrame: 3rd, 7th, and 14th post-extraction day
Other outcomes:
Locations:
city: Chittagong
country: Bangladesh
facility: Chittagong Medical College
Study officials:
affiliation: Chittagong Medical College
name: Md Salim Uddin, BDS, MPhil
role: PRINCIPAL_INVESTIGATOR
References: