Estimation of the need of antibiotic coverage after routine tooth extraction

Not yet recruiting

Conditions: Healthy Human Volunteers who are in need of regular non-surgical dental extractions

Registration Number: CTRI/2025/04/084047

Lead Sponsor: Saraswati Dental College and Hospital

Brief Summary: **Research Design** A randomized double-blind controlled trial (RCT) for determining the adequacyof prescribing prophylactic antibiotics in routine dental extractions ofhealthy patients.

**2. Research Setting** Department of Oral & Maxillofacial Surgery, Saraswati Dental College andHospital, Lucknow.

**3. Target Population** Patients aged between 18 years to 60 years, who are inhabitant of the cityLucknow, will be selected randomly as per the inclusion and exclusion criteriamentioned below irrespective of their gender, caste, creed, religion andsocioeconomic status.

**4. Inclusion and Exclusion Criteria** **Inclusion Criteria:**

- Age 18-60 years

- ASA Classification I & II

- No active oral infections

- No recent antibiotic use (within two weeks)

**Exclusion Criteria:**

- Allergies to trial antibiotics

- Pregnant/lactating women

- History of recent infections or medication affecting wound healing

- Patients having contradictions for routine dental extractions.

**Procedure for Data Collection**

- Screening and informed consent

- Random allocation into non-antibiotic, pre extraction-antibiotic and post extraction-antibiotic groups

- Standardized extraction procedure by trained oral surgeons

- Post-operative monitoring at Day 3, 7, and 15

- Assessment of infection rates, pain levels, and healing outcomes

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 600

Inclusion Criteria

ASA Classification I & II No active oral infections No recent antibiotic use (within two weeks).

Exclusion Criteria

Allergies to trial antibiotics Pregnant/lactating women History of recent infections or medication affecting wound healing Patients having contradictions for routine dental extractions.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare post-operative infection rates between antibiotic and non-antibiotic groups.	Follow-up will be done on post operative day 3, 7 and 15.
To assess post extraction wound healing, pain, and swelling in both groups.	Follow-up will be done on post operative day 3, 7 and 15.

Secondary Outcome Measures

Name	Time	Method
To determine the economic impact of antibiotic use in routine dental extractions.	To provide evidence-based recommendations on antibiotic prophylaxis in healthy patients.

Trial Locations

Locations (1): Saraswati Dental College and Hospital
🇮🇳
Lucknow, UTTAR PRADESH, India
Saraswati Dental College and Hospital
🇮🇳Lucknow, UTTAR PRADESH, India
DR Himanshu Chauhan
Principal investigator
07905879163
drhimanshu7988@gmail.com