| CTRI Number |
CTRI/2024/07/070746 [Registered on: 16/07/2024] Trial Registered Prospectively |
| Last Modified On: |
09/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Comparing Two Methods for Gum Recession Treatment: A Study on Root Coverage Using Different Grafts.one is sub-epithelial connective tissue and other one is operculum from erupting third molar. |
|
Scientific Title of Study
|
Comparative evaluation of root coverage using subepithelial connective tissue and de-epithelized pericoronal flap autograft-a randomized control 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 Aishwarya |
| Designation |
PG student |
| Affiliation |
KVG Dental College and Hospital |
| Address |
Room no 11 Department of Periodontology KVG Dental College and Hospital Kuranjibhag Sullia Dakshina Kannada Karnataka India
Pincode 574327
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
9353852262 |
| Fax |
|
| Email |
bruhanmathaishwarya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M M Dayakar |
| Designation |
Professor and HOD |
| Affiliation |
KVG Dental College and Hospital |
| Address |
Room no 11 Department of Periodontology KVG Dental College and Hospital Kuranjibhag Sullia Dakshina Kannada Karnataka India
Pincode 574327
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
9448167427 |
| Fax |
|
| Email |
mmdayakar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M M Dayakar |
| Designation |
Professor and HOD |
| Affiliation |
KVG Dental College and Hospital |
| Address |
Room no 11 Department of Periodontology KVG Dental College and Hospital Kuranjibhag Sullia Dakshina Kannada Karnataka India
Pincode 574327
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
9448167427 |
| Fax |
|
| Email |
mmdayakar@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Room no 11, Department of Periodontology, KVG Dental College and Hospital. Kuranjibhag, Sullia. |
|
|
Primary Sponsor
|
| Name |
Dr Aishwarya |
| Address |
Room no 11 Department of Periodontology KVG Dental College and Hospital Kuranjibhag Sullia Dakshina Kannada Karnataka India
Pincode 574327 |
| 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 |
| Dr Aishwarya |
KVG Dental College and Hospital |
Room no 11 Department of Periodontology KVG Dental College and Hospital Kuranjibhag Sullia Dakshina Kannada Karnataka India
Pincode 574327
Dakshina Kannada
KARNATAKA |
9353852262
bruhanmathaishwarya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KVG dental college and hospital, Sullia. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K060||Gingival recession, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
De-epithelized pericoronal flap from erupting third molar |
Pericoronal flap from erupting third molar is excised and de-epithelized and used as a graft in root coverage with RT1 recession. Duration of the procedure will be 30 minutes. |
| Comparator Agent |
Sub epithelial connective tissue graft |
Sub epithelial connective tissue graft used as a graft in root coverage with RT1 recession. The duration of procedure will be 30 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
(1) Patients with good general health,
(2) Patients who were nonsmokers,
(3) Patients having no history of any medication affecting periodontal healing.
(4) Patients with single tooth RT1 gingival recession
(5) Patients with erupting third molar having adequate operculum for single
tooth RT1recession
|
|
| ExclusionCriteria |
| Details |
1) History of systemic diseases,
(2) Pregnant or lactating patients,
(3) Inadequate oral hygiene after Phase I therapy,
(4) Allergic to any medication, and
(5) Patients with thin palatal connective tissue.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the treatment outcome following sub epithelial connective tissue and de-epithelized pericoronal flap.
|
1st month
2nd month
3rd month
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the gingival recession depth, width of keratinized gingiva, clinical attachment level, attached gingiva & percentage of root coverage following root coverage using sub epithelial connective tissue graft.
To evaluate the gingival recession depth, width of keratinized gingiva, clinical attachment level, attached gingiva & percentage of root coverage following root coverage using de-epithelized pericoronal flap.
|
1st month
2nd month
3rd month |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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)
|
06/01/2025 |
| 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="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
End point of periodontal therapy is to regenerate
tooth supporting structures that have been lost. In this study main aim is to
regenerate soft tissue using subepithelial connective tissue graft and
operculum as autografts in root coverage.
Gingival recession refers to the apical displacement
of the marginal gingiva from its usual location on the tooth crown to a
position along the root surface, extending beyond the cementoenamel junction.
Causes for gingival attachment loss are poor oral
hygiene subgingival calculus, improper brushing technique, high frenal
attachment, improperly designed partial dentures, improper restoration,
chemicals, some pathological conditions
Auto graft is a tissue taken from the same person.it
is more reliable And chances of infection and rejection are less. Both
subepithelial connective tissue and de-epithelized pericoronal flap have good
outcomes in root coverage, double blood supply is created, greater marginal
thickness can be obtained.
This study evaluates and compare the clinical outcomes
of root coverage and gingival marginal thickness. which will be evidence based
guidance for clinicians to select suitable technique. |