| CTRI Number |
CTRI/2024/07/070588 [Registered on: 15/07/2024] Trial Registered Prospectively |
| Last Modified On: |
05/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation A-PRF impregnated with DFDBA in the treatment of recession defects in maxillary anterior region. |
|
Scientific Title of Study
|
Comparative evaluation of vestibular incision subperiosteal tunnel access (VISTA) technique with and without A-PRF impregnated with DFDBA in the treatment of recession defects in maxillary anterior region – A randomized 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 Siddhi Sonare |
| Designation |
Post Graduate |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre |
| Address |
104, Department of Periodontics and Implantology
Ranjeet Deshmukh Dental College and Research Centre,
Digdoh Hills, Hingna road
Nagpur 440019
Maharashtra India
Nagpur
MAHARASHTRA
440019
India |
| Phone |
7058944106 |
| Fax |
|
| Email |
siddhi18.sonare@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhay Kolte |
| Designation |
Dean and HOD |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre |
| Address |
104, Department of Periodontics and Implantology
Ranjeet Deshmukh Dental College and Research Centre,
Digdoh Hills, Hingna road
Nagpur 440019
Maharashtra India
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9011071467 |
| Fax |
|
| Email |
drabhaypkolte@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhay Kolte |
| Designation |
Dean and HOD |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre |
| Address |
104, Department of Periodontics and Implantology
Ranjeet Deshmukh Dental College and Research Centre,
Digdoh Hills, Hingna road
Nagpur 440019
Maharashtra India
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9011071467 |
| Fax |
|
| Email |
drabhaypkolte@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Siddhi Sonare |
| Address |
104, Department of Periodontics and Implantology Ranjeet Deshmukh Dental College and Research Centre Digdoh Hills, Hingna road, Nagpur 440019 |
| Type of Sponsor |
Other [Self sponsered PG thesis] |
|
|
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 Siddhi Sonare |
Ranjeet Deshmukh Dental College and Research Centre |
104, Department of Periodontics and Implantology Ranjeet Deshmukh Dental College and Research Centre
Digdoh Hills, Hingna road
Nagpur 440019
Maharashtra India
Nagpur
MAHARASHTRA |
7058944106
siddhi18.sonare@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ranjeet Deshmukh Dental College and Research Centre Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K055||Other periodontal diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
VISTA technique with A-PRF impregnated with DFDBA |
Vestibular incision subperiosteal tunnel access (VISTA) technique with A-PRF impregnated with DFDBA in the treatment of recession defects in maxillary anterior region |
| Comparator Agent |
VISTA technique without A-PRF impregnated with DFDBA |
Vestibular incision subperiosteal tunnel access (VISTA) technique without A-PRF impregnated with DFDBA in treatment of recession defects in maxillary anterior region |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Systemically healthy patients.
Patient with healthy and stable soft tissue architecture.
Co-operative, motivated and hygiene conscious patients.
Patients exhibiting bilateral Miller’s Class I or II maxillary anterior gingival recession defects.
Patients with ≥1mm of attached gingiva at gingival recession sites.
|
|
| ExclusionCriteria |
| Details |
1. Pregnant or lactating females
2. Tobacco smokers
3. Patients treated with any medication known to cause gingival enlargement
4. Drug and alcohol abuse
5. In addition, non vital teeth, carious teeth warranting restorations and mobility greater than grade II will also be excluded
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare root coverage and labial plate thickness in maxillary anterior recession defects clinically and radiographically. |
Baseline and 9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare probing depth (PD), clinical attachment level (CAL), width of keratinized gingiva (WKG), recession depth (RD), gingival thickness (GT) and complete root coverage (CRC) in maxillary anterior gingival recession defects when treated with VISTA technique with and without A- PRF impregnated with DFDBA at baseline, 3 and 6 months postoperatively. |
Baseline, 3 and 6 months |
| 2. To evaluate and compare labial plate thickness at 1mm, 3mm and 5mm apical to the CEJ in maxillary anterior gingival recession defects when treated with VISTA technique with and without A- PRF impregnated with DFDBA at baseline and 9 months postoperatively through CBCT. |
Baseline and 9 months |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
25/07/2024 |
| 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="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
|
This cross-sectional study will be conducted to evaluate and compare VISTA technique with and without A-PRF impregnated with DFDBA in the treatment of maxillary anterior recession defects clinically and radiographically Total of 30 subjects exhibiting bilateral Miller’s class I or II maxillary anterior gingival recession defect visiting the Department of Periodontics at Ranjeet Deshmukh Dental College and Research Centre, Nagpur will be recruited as per the inclusion criteria will participate in the study. The participants will be divided Patients will be divided as: Group I – Class I/ II maxillary anterior recession defects treated with VISTA technique alone. Group II – Class I/ II maxillary anterior recession defects treated with VISTA technique with A-PRF impregnated with DFDBA. Written informed consent will be taken from the patients who wish to enroll in the study. VISTA technique with and without A-PRF impregnated with DFDBA in the treatment of maxillary anterior recession defects is evaluated clinically and radiographically using Cone Beam Computed Tomography. |