| CTRI Number |
CTRI/2020/04/024506 [Registered on: 07/04/2020] Trial Registered Prospectively |
| Last Modified On: |
28/03/2020 |
| 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 the VISTA technique alone and with concentrated growth factor in the management of bilateral multiple adjacent gingival recession defects. |
|
Scientific Title of Study
|
Comparative evaluation of VISTA technique alone and with concentrated growth factors (CGF) in the management of bilateral multiple adjacent gingival recession defects: A clinical study
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gajanan Shantilal Chandode |
| Designation |
Post Graduate Student |
| Affiliation |
Department of Periodontics and Implantology VSPM Dental College and Research Centre, Nagpur |
| Address |
Dept. of Periodontics & Implantology,
VSPM Dental College & Research Centre,
Digdoh Hills, Hingna Road
Nagpur -440019
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9594224505 |
| Fax |
|
| Email |
gajananchandode24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhay P Kolte |
| Designation |
Prof. & Guide, HOD |
| Affiliation |
Department of Periodontics & Implantology, V.S.P.M Dental College & Research Centre, Nagpur |
| Address |
Dept. of Periodontics & Implantology,
V.S.P.M Dental College & Research Centre,
Digdoh Hills, Hingna Road,
Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9011071467 |
| Fax |
|
| Email |
drabhaypkolte@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhay P Kolte |
| Designation |
Prof. & Guide, HOD |
| Affiliation |
Department of Periodontics & Implantology, V.S.P.M Dental College & Research Centre, Nagpur |
| Address |
Dept. of Periodontics & Implantology,
V.S.P.M Dental College & Research Centre,
Digdoh Hills, Hingna Road,
Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9011071467 |
| Fax |
|
| Email |
drabhaypkolte@gmail.com |
|
|
Source of Monetary or Material Support
|
| V.S.P.M. DENTAL COLLEGE AND RESEARCH CENTRE, DIGDOH HILLS, HINGNA, NAGPUR |
|
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Primary Sponsor
|
| Name |
DR GAJANAN SHANTILAL CHANDODE |
| Address |
Department of Periodontics and Implantology
VSPM Dental College & Research Centre
Digdoh Hills, Hingna Road
Nagpur: 440019
Maharashtra, India
|
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gajanan Shantilal Chandode |
VSPM Dental College and Research CentreDigdoh Hills, Hingna road Nagpur: 440019 |
Department of Periodontics and Implantology,Digdoh Hills, Hingna road Nagpur: 440019 Maharashtra India
Nagpur
MAHARASHTRA |
9594224505
gajananchandode24@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 |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K05||Gingivitis and periodontal diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
VISTA Technique |
In this study we will evaluate the efficacy of concentrated growth factor membrane placed once along with VISTA over VISTA alone in the treatment of bilateral multiple adjacent gingival recession defects, clinically. |
| Intervention |
VISTA Technique with Concentrated Growth Factor(CGF) |
In this study we will evaluate the VISTA technique with concentrated growth factor membrane placed once, at the time of surgery in the management of multiple adjacent gingival recession defects. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients exhibiting bilateral multiple gingival recession defects (Miller Class I or II recession) with no interproximal hard and soft tissue destruction will be selected.
2)Patients with more than or equal to 1mm of attached gingiva at gingival recession sites.
|
|
| ExclusionCriteria |
| Details |
1)Patients with history of any known systemic disease, bone metabolism that would alter the healing response of the oral tissues will be excluded.
2)Smoker patients.
3)Patients who are pregnant and lactating mothers will be excluded from study.
4)Patients who have undergone periodontal therapy in the past 6 months 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, Outcome Assessor and Date-entry Operator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in periodontal status i.e. Root coverage at baseline, 3 months and 6 months in both groups. |
baseline, 3 months and 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Gingival index (GI), Width of keratinized gingiva (WKG), Probing depth (PD), Clinical attachment level (CAL), Gingival thickness (GT), Recession depth (RD) in gingival recession defects treated with VISTA technique alone and in combination with concentrated growth factor at baseline, 3 and 6 months postoperatively |
Baseline, 3 months, 6 months |
|
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Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
09/04/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Study will be conducted to evaluate efficacy of VISTA along
with concentrated growth factor over VISTA alone in treatment of bilateral
multiple adjacent gingival recession
defects (millers class I/ II gingival recession defects)
patients, clinically. A total of 20 participants (90 defects) 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 (45 defects–Control site): Patients
exhibiting multiple gingival recession defects (millers class I/ II gingival
recession defects) undergoing VISTA alone.
Group II (45 defects–Test site): Patients
exhibiting multiple gingival recession defects (millers class I/ II gingival
recession defects) undergoing VISTA followed by placement of
CGF.
The primary outcome will be improvement in periodontal
status i.e. Root coverage at baseline, 3 months and 6 months in both groups.
The secondary outcome will be improvement in Gingival index
(GI), Width of keratinized gingiva (WKG), Probing depth (PD), Clinical
attachment level (CAL), Gingival thickness
(GT), Recession depth (RD) in gingival recession defects
treated with VISTA technique alone and with Concentrated Growth Factor(CGF)
i.e. In both the groups at baseline, 3 and
6 months 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. Gingival index (GI-Loe and Silness).
2. Width of keratinized gingiva (WKG).
3. Probing depth (PD).
4. Clinical attachment level (CAL).
5. Gingival thickness (GT).
6. Recession depth (RD).
Evaluation of Root coverage percentage
Post-operatively root coverage percentage of each group
will be evaluated using the following formula
(Preoperative recession depth - Postoperative recession
depth)
------------------------------------------------------------------------------
× 100
Preoperative recession depth
The above parameters will be recorded with the UNC-15
periodontal probe.
Initial therapy will consist of detailed oral hygiene
instructions and Scaling Root Planing (SRP). A re-evaluation examination will
be performed at 6 weeks following the completion of
initial therapy to confirm the need for surgery. Clinical
parameters will be evaluated at baseline. Under local anaesthesia, vertical
incision of 3mm in length will be given from
attached gingiva to alveolar mucosa followed by
sub-periosteal tunnel preparation with the help of special set of periosteal
elevators (VISTA 1,2,3,4) through vestibular access. This
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