| CTRI Number |
CTRI/2025/06/089046 [Registered on: 18/06/2025] Trial Registered Prospectively |
| Last Modified On: |
17/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Gum Shrinkage Therapy Using Nature-Inspired Techniques and 3D Analysis |
|
Scientific Title of Study
|
Evaluation Of Tunneling Technique With Amniotic Membrane Titanium-Platlet Rich Fibrin For Recession Coverage A Soft Tissue Cone Beam Computed Tomography Analysis |
| 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 Mansi Varshney |
| Designation |
Junior Resident |
| Affiliation |
Institute Of Dental Sciences Bareilly |
| Address |
Room Number 228 Department Of Periodontics Institute Of Dental Sciences Bareilly
Room Number 223 Department Of Periodontics Institute Of Dental Sciences Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
7290859807 |
| Fax |
|
| Email |
mansivarshney786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rika Singh |
| Designation |
Professor And Head |
| Affiliation |
Institute Of Dental Sciences Bareilly |
| Address |
Room Number 228 Department Of Periodontics Institute Of Dental Sciences Bareilly
Room Number 223 Department Of Periodontics Institute Of Dental Sciences Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9458411133 |
| Fax |
|
| Email |
rikasingh22@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rika Singh |
| Designation |
Professor And Head |
| Affiliation |
Institute Of Dental Sciences Bareilly |
| Address |
Room Number 228 Department Of Periodontics Institute Of Dental Sciences Bareilly
Room Number 223 Department Of Periodontics Institute Of Dental Sciences Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9458411133 |
| Fax |
|
| Email |
rikasingh22@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Institute Of Dental Sciences Bareilly |
| Address |
Room Number 228 Department Of Periodontics Institute Of Dental Sciences Bareilly |
| Type of Sponsor |
Other [Institute of dental sciences Bareilly] |
|
|
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 Mansi Varshney |
Institute Of Dental Sciences Bareilly |
Department of Periodontics Room No 228
Bareilly
UTTAR PRADESH |
7290859807
mansivarshney786@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee IDS Bareilly |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Amniotic Membrane |
In group 1 a surgical template will be employed to measure the defect size and the amniotic membrane Tissue Bank Tata memorial hospital Mumbai Maharashtra will be trimmed accordingly to fit the surgical area The membrane will be inserted into the subperiosteal tunnel, and along with the membrane and the mucogingival complex will be sutured after appropriate coronal placement |
| Intervention |
Titanium Platelet Rich Fibrin |
In Group 2 9 ml of blood will be drawn from the patient and centrifuged at 2800 rpm for 12 minutes to prepare the T PRF The freshly prepared T PRF membrane will then trimmed and placed within the subperiosteal tunnel. Gentle pressure will be applied for 3 minutes to stabilize the membrane, which will be then followed by suturing. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients above the age of 18yrs with one or more adjacent Type I recession site Miller Class I
Individuals who will be systemically healthy with good oral hygiene practices.
A visible cementoenamel junction CEJ and having a probing depth PD less than or equal to 4mm |
|
| ExclusionCriteria |
| Details |
They will have nonvital teeth at or adjacent to the recession site.
Presence of cervical defects
Pregnant or lactating women
Those who had received any periodontal surgery or regenerative treatments in the last 6 months
Restorations in adjacent teeth that could interfere with surgical success.
Patients who are current smokers or with smoking history
Patients with active periodontal disease
Individuals on any medications that might disrupt periodontal tissue condition or healing process
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate clinical efficiency of amniotic membrane for recession coverage using tunnel technique.
To evaluate clinical efficiency of T-PRF for recession coverage using tunnel technique.
To compare the clinical results of using amniotic membrane versus T-PRF along with tunnel technique in the treatment of gingival recession defects.
To evaluate and compare the gingival tissue thickness before and after recession coverage using soft tissue CBCT technique.
|
To evaluate clinical efficiency of amniotic membrane for recession coverage using tunnel technique.
To evaluate clinical efficiency of T-PRF for recession coverage using tunnel technique.
To compare the clinical results of using amniotic membrane versus T-PRF along with tunnel technique in the treatment of gingival recession defects.
To evaluate and compare the gingival tissue thickness before and after recession coverage using soft tissue CBCT technique.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • To evaluate clinical efficiency of amniotic membrane for recession coverage using tunnel technique. |
baseline(preoperatively) and at 6 months after the procedure. |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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 |
|
Date of First Enrollment (India)
|
18/07/2025 |
| 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="1"
Months="0"
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
|
Gingival recession GR is the apical displacement of the gingival margin exposing the tooth root and potentially causing sensitivity aesthetic issues and root caries. While traditional treatments like connective tissue grafts CTG are effective they involve donor site morbidity. The Vestibular Incision Subperiosteal Tunnel Access VISTA technique a minimally invasive method allows for efficient root coverage with fewer complications. This study aims to compare the clinical effectiveness of two biomaterials Amniotic Membrane AM and Titanium Platelet Rich Fibrin T PRF used in conjunction with the VISTA technique in treating Millers Class I gingival recession. The comparison focuses on parameters like gingival thickness keratinized tissue width recession height and mean root coverage. A total of 24 sites will be randomly assigned to two groups 12 AM 12 T PRF. Pre and post operative measurements, including soft tissue CBCT for gingival thickness will be recorded and analyzed statistically. The study is designed to determine which biomaterial offers better clinical outcomes and tissue regeneration potential, contributing to more effective, minimally invasive treatment strategies for gingival recession.
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