Evaluation of Antibiotic Administration Following Tooth Extraction
NCT ID: NCT06502288
Last Updated: 2024-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
152 participants
INTERVENTIONAL
2025-01-01
2025-10-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
TREATMENT
TRIPLE
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.
Study Groups
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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.
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.
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.
No interventions assigned to this group
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Provide informed written consent
3. Patients aged between 18 to 50 years
Exclusion Criteria
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
18 Years
50 Years
ALL
Yes
Sponsors
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Chittagong Medical College
OTHER
Responsible Party
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Salim Uddin
Lecturer, Children Dentistry
Principal Investigators
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Md Salim Uddin, BDS, MPhil
Role: PRINCIPAL_INVESTIGATOR
Chittagong Medical College
Locations
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Chittagong Medical College
Chittagong, , Bangladesh
Countries
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Central Contacts
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Facility Contacts
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Md Salim Uddin, BDS, MPhil
Role: primary
Other Identifiers
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59.27.0000.013.19.PG.2024/324
Identifier Type: -
Identifier Source: org_study_id
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