Evaluation of Antibiotic Administration Following Tooth Extraction
NCT Number: NCT06502288
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Tooth Extraction
Interventions: DRUG: 625 mg of amoxicillin with combined clavulanic acid tablet
Sponsor: Chittagong Medical College
Sex: ALL
Age: ADULT
Enrollment: 152
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2025-01-01
Completion Date: 2025-10-15
Locations: Chittagong Medical College, Chittagong, Bangladesh

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.

Primary Outcome Measures: 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: 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