| CTRI Number |
CTRI/2024/07/070491 [Registered on: 11/07/2024] Trial Registered Prospectively |
| Last Modified On: |
05/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A study to compare local and systemic antibiotics on wisdom tooth surgery |
|
Scientific Title of Study
|
A randomized controlled split mouth study of postoperative effects of locally delivered amoxicillin using platelet rich fibrin compared with preoperative systemic amoxicillin on impacted mandibular third molar surgery |
| 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 Nimsi |
| Designation |
PG student |
| Affiliation |
Manipal College of Dental Sciences |
| Address |
Department of oral and maxillofacial surgery, MCODS, Hampankatta, Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9866697959 |
| Fax |
|
| Email |
nimsikola@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. premalatha shetty |
| Designation |
professor |
| Affiliation |
Manipal College of Dental Sciences |
| Address |
Department of oral and maxillofacial surgery, MCODS, Hampankatta, Mangalore
KARNATAKA
575001
India |
| Phone |
9866697959 |
| Fax |
|
| Email |
premalatha.shetty@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nimsi |
| Designation |
PG student |
| Affiliation |
Manipal College of Dental Sciences |
| Address |
Department of oral and maxillofacial surgery, MCODS, Hampankatta, Mangalore
KARNATAKA
575001
India |
| Phone |
9866697959 |
| Fax |
|
| Email |
nimsikola@gmail.com |
|
|
Source of Monetary or Material Support
|
|
Manipal Dental College Of Dental Sciences, Managlore- 575001
Dakshina kannada, Karnataka, India. |
|
|
Primary Sponsor
|
| Name |
Dr Nimsi Kola |
| Address |
department of omfs, maniapal college of dental sciences, Hampankatta, Mangalore-575001, karnataka, india |
| Type of Sponsor |
Other [Self] |
|
|
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 Nimsi |
Manipal College Of Dental Sciences |
Department Of OMFS, Room No:2 Ground Floor, Hampankatta, Mangalore-575001
Dakshina Kannada
KARNATAKA |
9866697959
nimsikola@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee, Manipal College of Dental Sciences, Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K006||Disturbances in tooth eruption, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
amoxicillin |
0.5ml of amoxicillin equivalent to 125mg mixed with prf single dose will be placed in extraction socket |
| Comparator Agent |
pre op 1 gram amoxicillin |
1 gram pre-antibiotic and prf |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
subjects requiring surgical extraction of bilateral third molars
subjects who have informed consent |
|
| ExclusionCriteria |
| Details |
subjects with infection around third molars
subjects who are pregnant
subjects with systemic disorders
subjects who have allergy to amoxicillin
subjects who have used antibiotics in past 2 weeks
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Extraction Site Will Be Assessed For Pus Discharge And Mouth Opening. |
At 24 Hour, 72 Hour, 7th Day Post Operative Day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Less side Effects Of Systemic Antibiotics |
24 Hour, 72 hour, 7th Post Operativer Day |
|
|
Target Sample Size
|
Total Sample Size="29"
Sample Size from India="29"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/08/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Dentists frequently recommend systemic antibiotics to patients in order
to avoid complications like alveolitis and secondary infections. But inappropriate
use of antibiotics increases the risk of side effects for patients, including
gastrointestinal disturbances, medication interactions, allergic reactions,
headaches, nausea, weakness, fever, and diarrhoea. It also hastens the
emergence of antibiotic resistance. our study aims to evaluate whether or not PRF mixed with antibiotics
lowers the risk of postoperative infection, and hence, replaces or supplements
systemic antibiotic therapy, while also providing the healing benefits of PRF. |