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CTRI Number  CTRI/2025/04/084047 [Registered on: 03/04/2025] Trial Registered Prospectively
Last Modified On: 21/03/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Estimation of the need of antibiotic coverage after routine tooth extraction 
Scientific Title of Study   Evaluation of the need for antibiotic prophylaxis after routine intra-alveolar dental extractions in healthy patients: A randomized double blind controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR Himanshu Chauhan 
Designation  Reader  
Affiliation  Department of Oral and Maxillofacial Surgery, Ground Floor, Room number 2,Saraswati Dental College and Hospital 
Address  Tiwari Ganj 233 Faizabad Rd Uattardhona Uttar Pradesh

Lucknow
UTTAR PRADESH
226028
India 
Phone  7905879163  
Fax    
Email  drhimanshu7988@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR Himanshu Chauhan 
Designation  Reader  
Affiliation  Department of Oral and Maxillofacial Surgery, Ground Floor, room Number 2,Saraswati Dental College and Hospital 
Address  Tiwari Ganj 233 Faizabad Rd Uattardhona Uttar Pradesh

Lucknow
UTTAR PRADESH
226028
India 
Phone  7905879163  
Fax    
Email  drhimanshu7988@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR Himanshu Chauhan 
Designation  Reader  
Affiliation  Department of Oral and Maxillofacial Surgery, Ground Floor, Room Number 2,Saraswati Dental College and Hospital 
Address  Tiwari Ganj 233 Faizabad Rd Uattardhona Uttar Pradesh

Lucknow
UTTAR PRADESH
226028
India 
Phone  7905879163  
Fax    
Email  drhimanshu7988@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Saraswati Dental College and Hospital 
Address  Tiwari Ganj 233 Faizabad Rd Uattardhona Uttar Pradesh 226028 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR Himanshu Chauhan  Saraswati Dental College and Hospital  Department of Oral and MAxillofacial Surgery, Ground Floor, Room Number 2, Tiwari Ganj 233 Faizabad Rd Uattardhona Uttar Pradesh 226028
Lucknow
UTTAR PRADESH 
07905879163

drhimanshu7988@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Human Volunteers who are in need of regular non-surgical dental extractions 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group 1 - No Prophylactic Antibiotics will be given pre or post operatively.  No Prophylactic Antibiotics will be given pre or post operatively. Follow-up will be done on post operative Day 3, 7 and 15. 
Intervention  Group 2 - Pre-operative loading dose of antibiotic 20 mins prior to the procedure.  Single dose of 1.2gms of Amoxicillin and Clavulanic acid 20mins prior to the procedure.Follow-up will be done on post operative day 3,7 and 15. 
Comparator Agent  Group 3 - Post-operative prophylactic antibiotic will be provided for 3 days.  Amoxicillin 500mg and Clavulanic acid 125mg B.D. for 3days post operatively will be prescribed.Follow-up will be done on post operative day 3, 7 and 15. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA Classification I & II
No active oral infections
No recent antibiotic use (within two weeks)
 
 
ExclusionCriteria 
Details  Allergies to trial antibiotics
Pregnant/lactating women
History of recent infections or medication affecting wound healing
Patients having contradictions for routine dental extractions.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
To compare post-operative infection rates between antibiotic and non-antibiotic groups.
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  
Outcome  TimePoints 
To determine the economic impact of antibiotic use in routine dental extractions.
To provide evidence-based recommendations on antibiotic prophylaxis in healthy patients. 
Follow-up will be done on day 15. 
 
Target Sample Size   Total Sample Size="600"
Sample Size from India="600" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/04/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Research Design
A randomized double-blind controlled trial (RCT) for determining the adequacy of prescribing prophylactic antibiotics in routine dental extractions of healthy patients.

2. Research Setting
Department of Oral & Maxillofacial Surgery, Saraswati Dental College and Hospital, Lucknow.

3. Target Population
Patients aged between 18 years to 60 years, who are inhabitant of the city Lucknow, will be selected randomly as per the inclusion and exclusion criteria mentioned below irrespective of their gender, caste, creed, religion and socioeconomic 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
 
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