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
|
|
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
|
|
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
|
|
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
|