| CTRI Number |
CTRI/2024/12/078827 [Registered on: 31/12/2024] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Vestibular incision subperiosteal tunnel access technique with and without PRF for gingival recession |
|
Scientific Title of Study
|
COMPARATIVE EVALUATION OF TREATMENT OF GINGIVAL RECESSION DEFECTS USING VESTIBULAR INCISION SUBPERIOSTEAL TUNNEL ACCESS (VISTA) TECHNIQUE WITH AND WITHOUT PLATELET RICH FIBRIN: A 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)
Modification(s)
|
| Name |
Riya Agarwal |
| Designation |
Post Graduate |
| Affiliation |
|
| Address |
subharti dental college
swami vivekanand subharti university NH-58 Delhi Hardiwar bypass road meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
7017748651 |
| Fax |
|
| Email |
drriyagarwal57@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sameer Ahmed |
| Designation |
Reader |
| Affiliation |
subharti dental college |
| Address |
Swami vivekanand subharti university NH-58 Delhi Hardiwar bypass road meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9928634117 |
| Fax |
|
| Email |
sameer82ahmed@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sameer Ahmed |
| Designation |
Reader |
| Affiliation |
subharti dental college |
| Address |
Swami vivekanand subharti university NH-58 Delhi Hardiwar bypass road meerut
UTTAR PRADESH
250005
India |
| Phone |
9928634117 |
| Fax |
|
| Email |
sameer82ahmed@gmail.com |
|
|
Source of Monetary or Material Support
|
|
Primary Sponsor
Modification(s)
|
| Name |
Dr Riya Agarwal |
| Address |
swami vivekanand subharti university subharti dental college NH-58 delhi hardiwar bypass road meerut |
| 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 riya agarwal |
subharti dental college and hospital |
swami vivekanand subharti university NH-58 delhi hardiwar bypass road meerut
Meerut
UTTAR PRADESH |
7017748651
drriyaagarwal57@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| university ethics commitee (medical) swami vivekanand subharti university |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z66||Do not resuscitate, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GROUP A VISTA with PRF |
ten patients with miller class I and class II gingival recession defect
follow up for 3months will be done |
| Comparator Agent |
GROUP B VISTA WITHOUT PRF |
TEN patients with Miller class I and class II gingival recession defect
follow up for 3 months will be done |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
66.00 Year(s) |
| Gender |
Both |
| Details |
Age group ranging from 20-60 years.
2. Presence of Miller’s Class I and II gingival recession defects in maxillary and mandibular arch.
3. Subjects who are systemically healthy with no contraindication to Periodontal surgery
4. No previous history of periodontal therapy at the affected teeth
Evidence of patient’s ability to perform good plaque control
|
|
| ExclusionCriteria |
| Details |
1. Subjects having any deleterious habits, such as smoking or tobacco chewing.
2. Subjects with history of any systemic disease.
3. Recession defects associated with demineralization/caries,radiographic evidence of bone loss, deep abrasion or restorations as well as teeth with evidence of pulpal pathology.
4. Subjects showing unacceptable oral hygiene compliance during / after Phase-I therapy.
5. Pregnant or lactating females
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| recession length and recession width using UNC-15 and vernier calliper |
baseline , 1 month ,3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
15/01/2025 |
| 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="6"
Days="21" |
|
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
|
VISTA is a minimally invasive procedure for root coverage. The technique entails performing a vertical vestibular incision in the mucosa subsequently, the elevation of the subperiosteal tunnel is continued through the vertical incision thus allowing coronal repositioning of gingival margins. The remote incision reduces the possibility of traumatizing the gingiva of the teeth being treated. Subperiosteal incision reduces the tension of the gingival margin during coronal advancement while at the same time maintaining the anatomical integrity of the interdental papillae by avoiding papillary reflection. The placement of the initial incision and a tunnel entrance within the remote area of incision results in little to no visible scaring assisting in attaining the maximum esthetic outcome.Hence an attempt has been made to evaluate and compare the treatment of the gingival recession defect by using VISTA technique with and without leukocytes platelets rich fibrin. |