| CTRI Number |
CTRI/2021/01/030846 [Registered on: 29/01/2021] Trial Registered Prospectively |
| Last Modified On: |
28/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To Compare and evaluate pinhole surgical technique with and without Advanced platelet rich fibrin in the treatment of multiple adjacent recession defects in maxillary anterior region |
|
Scientific Title of Study
|
Comparative evaluation of pinhole surgical technique with and without A-PRF in the treatment of multiple adjacent recession defects in maxillary anterior region – A Randomized Controlled Trial
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Divya Suresh Trivedi |
| Designation |
Post Graduate Student |
| Affiliation |
VSPM Dental College and Research Centre Nagpur |
| Address |
Dept. of Periodontics & Implant Dentistry
VSPM Dental College & Research Centre
Digdoh Hills Hingna Road
Nagpur -440019
Maharashtra India
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9766076180 |
| Fax |
9011071467 |
| Email |
dtdiva3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhay Kolte Sir |
| Designation |
professor and HOD |
| Affiliation |
VSPM Dental College and Research Centre Nagpur |
| Address |
Dept of Periodontics & Implant Dentistry
VSPM Dental College & Research Centre
Digdoh Hills Hingna Road
Nagpur 440019
Maharashtra India
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9011071467 |
| Fax |
9011071467 |
| Email |
drabhaypkolte@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhay Kolte Sir |
| Designation |
professor and HOD |
| Affiliation |
VSPM Dental College and Research Centre Nagpur |
| Address |
Dept of Periodontics & Implant Dentistry
VSPM Dental College & Research Centre
Digdoh Hills Hingna Road
Nagpur 440019
Maharashtra India
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9011071467 |
| Fax |
9011071467 |
| Email |
drabhaypkolte@gmail.com |
|
|
Source of Monetary or Material Support
|
| 104 Department of Periodontics and Implant dentistry, VSPM Dental college and Research centre Hingna Nagpur |
|
|
Primary Sponsor
|
| Name |
Divya Suresh Trivedi |
| Address |
Dept of Periodontics & Implant Dentistry
VSPM Dental College & Research Centre
Digdoh Hills Hingna Road
Nagpur 440019
Maharashtra 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 |
| Divya Suresh Trivedi |
1)VSPM Dental college and Research Centre 2)Truescan diagnostics |
Dept of Periodontics & Implant Dentistry
VSPM Dental College & Research Centre
Digdoh Hills Hingna Road
Nagpur 440019
Maharashtra India
Nagpur
MAHARASHTRA |
9766076180
dtdiva3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VSPM Dental College and Research Centre Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K051||Chronic gingivitis, (2) ICD-10 Condition:V00-Y99||External causes of morbidity. Ayurveda Condition: Periodontal disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Surgical Root coverage technique |
This is an interventional study in which efficacy of Advanced Platelet rich fibrin(A-PRF) along with Pinhole Surgical Technique will be evaluated over Pinhole surgical technique alone in the treatment of bilateral multiple adjacent gingival recession defects clinically and radiographically |
| Intervention |
surgical root coverage technique |
This is an interventional study in which efficacy of Advanced Platelet rich fibrin(A-PRF) along with Pinhole Surgical Technique will be evaluated over Pinhole surgical technique alone in the treatment of bilateral multiple adjacent gingival recession defects clinically and radiographically |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Systemically healthy patients
2 Patient with healthy and stable soft tissue architecture
3 Co-operative, motivated and hygiene conscious patients
4 Patients exhibiting bilateral Millers Class I or II multiple adjacent gingival recession defects
5 Patients with ≥1mm of attached gingiva at gingival recession sites
|
|
| ExclusionCriteria |
| Details |
1 Pregnant or lactating females
2 Tobacco smokers
3 Uncontrolled medical conditions precluding elective surgery
4 Untreated periodontal conditions
5 Patients treated with any medication known to cause gingival hyperplasia
6 Drug and alcohol abuse
7 In addition, non-vital teeth, carious teeth warranting restorations and mobility > grade II will also be excluded
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Centralized |
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Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in Mean Root coverage at baseline 3 months and 6 months in both groups
|
baseline 3 months 6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Width of keratinized gingiva (WKG), Probing Pocket depth (PPD) Clinical attachment level (CAL) Recession depth (RD) in gingival recession defects treated with Pinhole surgical technique alone and in combination with A-PRF at baseline 3 and 6 months postoperatively |
baseline 3 month 6 month |
|
|
Target Sample Size
|
Total Sample Size="23"
Sample Size from India="23"
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)
|
01/02/2021 |
| 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
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Study will be conducted to evaluate efficacy of pinhole surgical technique along with A-PRF over pinhole surgical technique alone in treatment of bilateral multiple adjacent gingival recession defects (millers class I/ II gingival recession defects) patients, clinically A total of 23 participants affected with bilateral multiple adjacent gingival recession defects including both male and female visiting the Department of Periodontics at VSPM Dental College and research centre Nagpur will be recruited for this study In each patient two sites will be randomly assigned as Group I ( 23 patients- Control sites) – Class I/ II gingival recession defects treated with Pinhole Surgical Technique alone Group II (23 patients- Test sites) – Class I/ II gingival recession defects treated with Pinhole Surgical Technique with A-PRF The primary outcome will be improvement in Mean root coverage at baseline 3 months and 6 months in both groups The secondary outcome will be the Improvement in Width of keratinized gingiva (WKG) Probing Pocket depth (PPD) Clinical attachment level (CAL) Recession depth (RD) in gingival recession defects treated with Pinhole surgical technique alone and in combination with A-PRF at baseline 3 and 6 months clinically and radiographically with the help of CBCT postoperatively A brief description of entire procedure will be given to every patient before starting procedure. Written informed consent will be taken from the patients who wish to enrol in the study For all participants following periodontal parameters will be recorded 1 Full mouth plaque score (FMPS) 2 Full mouth bleeding score (FMBS) 3 Probing pocket depth (PPD) |