| CTRI Number |
CTRI/2019/12/022342 [Registered on: 12/12/2019] Trial Registered Prospectively |
| Last Modified On: |
11/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Necessity of antibiotic administration following dental extraction- A triple blinded randomized controlled trial |
|
Scientific Title of Study
|
Comparative evaluation of necessity of antibiotic administration following dental extraction among population of age group 30- 60 years - Triple blinded randomized control trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1240-8219 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sasidharan sivakumar |
| Designation |
BDS, PGDCR, (MDS) |
| Affiliation |
Best Dental Science College |
| Address |
Department of Public Health Dentistry,
Best dental science college,
Madurai.
Madurai
TAMIL NADU
625104
India |
| Phone |
8667718848 |
| Fax |
|
| Email |
sdmhoralcare@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Umesh K |
| Designation |
MDS |
| Affiliation |
Best Dental Science College |
| Address |
Department of Public Health Dentistry,
Best dental science college, Madurai.
Madurai
TAMIL NADU
625104
India |
| Phone |
9844334657 |
| Fax |
|
| Email |
drumeshk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sasidharan sivakumar |
| Designation |
BDS, PGDCR, (MDS) |
| Affiliation |
Best Dental Science College |
| Address |
Department of Public Health Dentistry,
Best dental science college,
Madurai.
Madurai
TAMIL NADU
625104
India |
| Phone |
08667718848 |
| Fax |
|
| Email |
sdmhoralcare@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Public Health Dentistry,
Best dental science college, Madurai- 625104 |
|
|
Primary Sponsor
|
| Name |
Best Dental Science College |
| Address |
69/1 ULTRA NAGAR Madurai, Chennai Hwy, Madurai. - 625104 |
| 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 |
| Sasidharan S |
Madurai, General population |
Ultra nagar, Madurai- 625104
Madurai
TAMIL NADU |
08667718848
sdmhoralcare@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BEST DENTAL SCIENCE COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Amoxicillin group |
Amoxicillin drug systemically post extraction as a gold standard prescribing style, 500mg, t.d.s |
| Intervention |
clindamycin group |
clindamycin drug as a mouthwash post extraction, 150mg in 100ml of water, t.d.s |
| Comparator Agent |
No antibiotic group |
Antibiotic is not prescribed post extraction |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patients aged 30 to 60years old gender non specific populations who are willing to participate in this study were included for the study. |
|
| ExclusionCriteria |
| Details |
Patients who were medically compromised, female patients who are pregnant or lactating and those women during menstruation period (disturbed fibrinolytic activity), and participants who are known hypersensitive to the test drugs used in this study, and tooth with abscess and cyst and patients taking antibiotics on pre operative 5days for any reason were all excluded |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The need for antibiotic administration during post extraction period will be limited when there is no significant difference between healing pattern for all three comparing groups. |
3rd day, 7th day and 14th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Healing comparison between 3 groups |
3rd day, 7th day, 14th day |
|
|
Target Sample Size
|
Total Sample Size="95"
Sample Size from India="95"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
16/12/2019 |
| 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="0"
Months="2"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The purpose of the study was to combat the antibiotic resistance by dentistry through enhancing the need for the antibiotic in post extraction period by comparatively evaluating the healing parameters for amoxicillin, clindamycin and no antibiotic group. |