Evaluation of Antibiotic Administration Following Tooth Extraction
ConditionTooth Extraction
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorChittagong Medical College
About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patient indicated extraction of teeth
Provide informed written consent
Patients aged between 18 to 50 years
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
625 mg of amoxicillin with combined clavulanic acid tablet
DrugThe intervention group must take 625 mg of amoxicillin with combined clavulanic acid tablets three times a day after meals for 7 days following extraction.
Treatment groups
152 Participants
are divided into 2 treatment groupsGroup A: Intervention Group-A: Administration of a specific antibiotic regimen post-extraction.Experimental treatment 1 intervention
Group B: Control Group-B: Administration of no antibiotic.No intervention 0 interventions
Trial outcomes
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.
Time frame
3rd, 7th, and 14th post-extraction daySecondary outcomes
1
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
Time frame
3rd, 7th, and 14th post-extraction day2
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
Time frame
3rd, 7th, and 14th post-extraction day3
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
Time frame
3rd, 7th, and 14th post-extraction daySponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: