| CTRI Number |
CTRI/2025/01/078847 [Registered on: 16/01/2025] Trial Registered Prospectively |
| Last Modified On: |
27/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of 0.2 percent Chlorhexidine Gel and Nanoemulsion Vitamin C Gel for Reducing Swelling After Wisdom Tooth Surgery: A Randomized Clinical Study |
|
Scientific Title of Study
|
Comparative Evaluation of 0.2 percent Chlorhexidine Gel and Nanoemulsion Vitamin C Gel in Post operative Oedema Following 3rd Molar surgery - A Randomized split mouth clinical study |
| 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 Rushil Patel |
| Designation |
Post Graduate Student |
| Affiliation |
Dr. D. Y. Patil Dental College and Hospital, Dr. D. Y. Patil Vidhyapeeth, Pimpri, Pune. |
| Address |
Department of Oral and Maxillofacial Surgery, OPD no. 9, Dr. D. Y. Patil Dental College and Hospital, Dr. D. Y. Patil Vidhyapeeth, Pimpri, Pune.
Pune
MAHARASHTRA
411018
India |
| Phone |
7622930900 |
| Fax |
|
| Email |
Rushilpatel747@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pushkar P Waknis |
| Designation |
Professor |
| Affiliation |
Dr. D. Y. Patil Dental College and Hospital, Dr. D. Y. Patil Vidhyapeeth, Pimpri, Pune. |
| Address |
Department of Oral and Maxillofacial Surgery, OPD no. 9, Dr. D. Y. Patil Dental College and Hospital, Dr. D. Y. Patil Vidhyapeeth, Pimpri, Pune.
Pune
MAHARASHTRA
411018
India |
| Phone |
9823047888 |
| Fax |
|
| Email |
Pushkar.waknis@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pushkar P Waknis |
| Designation |
Professor |
| Affiliation |
Dr. D. Y. Patil Dental College and Hospital, Dr. D. Y. Patil Vidhyapeeth, Pimpri, Pune. |
| Address |
Department of Oral and Maxillofacial Surgery, OPD no. 9, Dr. D. Y. Patil Dental College and Hospital, Dr. D. Y. Patil Vidhyapeeth, Pimpri, Pune.
Pune
MAHARASHTRA
411018
India |
| Phone |
9823047888 |
| Fax |
|
| Email |
Pushkar.waknis@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of Oral and Maxillofacial Surgery, OPD no. 9, Dr. D. Y. Patil Dental College and Hospital, Dr. D. Y. Patil Vidhyapeeth, Pimpri, Pune, Maharashtra, India 411018 |
|
|
Primary Sponsor
|
| Name |
Dr D Y Patil Dental College and Hospital Dr D Y Patil Vidhyapeeth Pimpri Pune |
| Address |
Department of Oral and Maxillofacial Surgery, OPD no. 9, Dr. D. Y. Patil Dental College and Hospital, Dr. D. Y. Patil Vidhyapeeth, Pimpri, Pune, Maharashtra, India 411018 |
| Type of Sponsor |
Private medical college |
|
|
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 Rushil Patel |
Dr. D. Y. Patil Denal College and Hospital, Pimpri, Pune. |
Department of Oral and Maxillofacial Surgery, OPD no. 9, Dr. D. Y. Patil Dental College and Hospital, Dr. D. Y. Patil Vidhyapeeth, Pimpri, Pune.
Pune
MAHARASHTRA |
7622930900
rushilpatel747@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Sub Committee, Dr. D. Y. Patil Dental College and Hospital, Dr. D. Y. Patil vidhyapeeth, Pune. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.2% Chlorhexidine Gel site |
0.2% chlorhexidine gel to be mixed with synthetic bone graft ( ALIVE OSS ) and to be placed in extraction socket (Locally) of left side after lower 3rd molar surgery |
| Intervention |
Nanoemulsion vitamin C Gel Site |
Nanoemulsion Vitamin C Gel - 100mg/ml to be mixed with synthetic bone graft ( ALIVE OSS ) and to be placed in extraction socket ( Locally ) of right side after lower 3rd molar surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Patients indicated for bilateral impacted lower 3rd molar surgery under local anesthesia, pederson difficulty index in between 5 and 6, Patients willing to participate in the study |
|
| ExclusionCriteria |
| Details |
Participants with uncontrolled systemic disease ( diabetes mellitus, asthma, hypertension, etc ), patient allergic to chlorhexidine and vitamin C. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Oedema according to Tape Measuring Method |
Base line, 1st week, 3rd week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Soft tissue healing, mouth opening |
Base line, 1st week, 3rd week |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
24/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
24/02/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
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
|
Dental extractions are common procedures, and postoperative complications such as oedema and delayed healing can impact patients’ well-being. Optimising postoperative care is crucial for reducing the risk of complications and ensuring a smooth recovery process. • Dental practitioners currently face the challenge of selecting the most appropriate local drug application for postoperative care. Evidence- based findings from this study can inform clinicians in making informed decisions, personalising care plans based on patient needs and characteristics. • Thus, we intend to do a comparative study, evaluating the efficacy of two local drug agent following 3rd molar surgery. On right side the extraction socket will be filled with Nanoemulsion vitamin c gel mixed with synthetic bone graft (ALIVE OSS ) and left extraction socket will be filled with 0.2% Chlorhexidine gel mixed with synthetic bone graft ( ALIVE OSS). And will be assessed for post operative oedema on 1st, 7th and 21th day with the help of Tape measuring method. |