| CTRI Number |
CTRI/2025/02/080057 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
07/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Pin hole versus Modified coronally advanced tunnel with GTR membrane in gingival recession. |
|
Scientific Title of Study
|
To Compare And Evaluate Pin Hole Technique And Modified Coronally Advanced Tunnel Technique With Perio-Col -GTR Membrane In Treating Maxillary Gingival Recession Defects- A Randomized 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)
|
| Name |
Dr Nancy Saxena |
| Designation |
post graduate student |
| Affiliation |
Subharti Dental College and Hospital meerut |
| Address |
Department of periodontology subharti dental college and hospital
Swami Vivekanand Subharti University Subharti Puram NH58 Delhi Haridwar NH58 Meerut Uttar Pradesh 250005
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9870661889 |
| Fax |
|
| Email |
drnancysaxena15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mehvish Saleem |
| Designation |
Associate Professor |
| Affiliation |
subharti dental college and hospital meerut |
| Address |
room no 2 department of periodonotology and implantology subbharti dental college and hospital
Swami Vivekanand Subharti University Subharti Puram NH58 Delhi Haridwar NH5 Meerut Uttar Pradesh 250005
Meerut
UTTAR PRADESH
250005
India |
| Phone |
8267011559 |
| Fax |
|
| Email |
mehvishkhan1087@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mehvish Saleem |
| Designation |
Associate Professor |
| Affiliation |
subharti dental college and hospital meerut |
| Address |
Room no 2 department of periodontology and implantology subharti dental college and hospital
Swami Vivekanand Subharti University Subharti Puram NH58 Delhi Haridwar NH58 Meerut Uttar Pradesh 250005
Meerut
UTTAR PRADESH
250005
India |
| Phone |
8267011559 |
| Fax |
|
| Email |
mehvishkhan1087@gmail.com |
|
|
Source of Monetary or Material Support
|
| Swami Vivekanand Subharti University, Subharti dental college and hospital,Subhartipuram, Department of periodontology and implantology, Ground floor, Room no. 2, NH-58, Delhi Haridwar, NH58, Meerut, Uttar Pradesh 250005 |
|
|
Primary Sponsor
|
| Name |
Dr Nancy Saxena |
| Address |
Swami Vivekanand Subharti University Subharti Puram NH58 Delhi Haridwar NH58 Meerut Uttar Pradesh 250005 India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Nancy Saxena |
Subharti Dental College and Hospital Meerut, Uttar Pradesh 250005, India |
room no 2 department of periodontology and implantology subharti dental college Swami Vivekanand Subharti University Subharti Puram NH58 Delhi Haridwar NH58 Meerut Uttar Pradesh 250005 India
Meerut
UTTAR PRADESH |
9870661889
drnancysaxena15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| UNIVERSITY ETHICS COMITTEE |
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 |
Modified Coronally Advanced Tunnel Technique with GTR |
Ten patients with gingival recession defects in maxillary anterior tooth region will be surgically treated with Modified Coronally Advanced Tunnel Technique plus GTR Periocol membrane for six months |
| Intervention |
Pin hole with GTR
|
Ten patients with gingival recession defects in maxillary anterior tooth region will be surgically treated with Pin hole technique plus GTR Periocol membrane for six months |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1 Age group ranging from 20-55 years
2 Presence of Millers Class I and II gingival recession defects in maxillary arch
3 Subjects who are systemically healthy with no contraindication to Periodontal surgery
4 No previous history of periodontal therapy at the affected teeth
5 Patient with 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
6 Subjects having undergone any periodontal therapy in the past three months
7 Subjects prescribed with steroidal chemotherapy Radiotherapy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Recession length and recession width measured by using UNC15 Periodontal probe and Digital Vernier caliper |
Baseline
3 months
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Gingival Index Loe and Silness 1963
Plaque Index Silness and Loe 1964
Width of keratinized gingiva measured by using UNC15 Periodontal probe
Clinical attachment level measured by using UNC15 Periodontal probe |
Baseline
3 months
6 months |
|
|
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)
|
20/02/2025 |
| 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="0"
Months="6"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
20 patients with either class I II gingival recession will be divided into two test groups and will be treated with minimally invasive approach using pin hole and modified coronally advanced tunnel technique with periocol membrane clinical parameters ie recession length recession width clinical attachment level will be assessed at baseline 3 months and 6 months efficacy and predictability of both the procedures will be assessed based on statistical analysis and whether any significant difference achieved or not |