| CTRI Number |
CTRI/2025/11/097023 [Registered on: 07/11/2025] Trial Registered Prospectively |
| Last Modified On: |
07/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARISON OF DE-EPITHELIALIZED GINGIVAL GRAFT OR DE-EPITHELIALIZED GINGIVAL UNIT GRAFT WITH TUNNELED CORONALLY ADVANCED FLAP FOR THE MANAGEMENT OF RT2 GINGIVAL RECESSION – A RANDOMIZED CLINICAL TRIAL |
|
Scientific Title of Study
|
COMPARISON OF DE-EPITHELIALIZED GINGIVAL GRAFT OR DE-EPITHELIALIZED GINGIVAL UNIT GRAFT WITH TUNNELED CORONALLY ADVANCED FLAP FOR THE MANAGEMENT OF RT2 GINGIVAL RECESSION – A RANDOMIZED CLINICAL TRIAL |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hiral Karwa |
| Designation |
Postgraudate student |
| Affiliation |
bapuji dental college and hospital |
| Address |
bapuji dental college and hospital,mcc b block ,577004 davnagere
Davanagere
KARNATAKA
577004
India |
| Phone |
7996605103 |
| Fax |
|
| Email |
hiralkarwa18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rucha Shah |
| Designation |
Professor |
| Affiliation |
bapuji dental college and hospital |
| Address |
bapuji dental college and hospital,mcc b block ,577004 davnagere
Davanagere
KARNATAKA
577004
India |
| Phone |
7676279879 |
| Fax |
|
| Email |
srucha2k@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Hiral Karwa |
| Designation |
postgraduate student |
| Affiliation |
bapuji dental college and hospital |
| Address |
bapuji dental college and hospital,mcc b block ,577004 davnagere
Davanagere
KARNATAKA
577004
India |
| Phone |
7996605103 |
| Fax |
|
| Email |
hiralkarwa18@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bapuji dental college and hospital,davangere,577004,india. |
|
|
Primary Sponsor
|
| Name |
SELF HIRAL |
| Address |
Bapuji dental college and hospital,mcc b block ,577004 davanagere,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 |
| Hiral Karwa |
Bapuji dental college and hospital |
Room no.5,Department of Periodontics,Bapuji dental college and hospital,mcc B block ,577004 ,Davangere,INDIA.
Davanagere
KARNATAKA |
7996605103
hiralkarwa18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional review board |
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 |
| Comparator Agent |
free gingival graft |
free gingival graft (FGG) will be harvested, the upper layer will be externally de-epithelialized. Two horizontal and two vertical incisions will define the graft area, with the blade placed along the horizontal incision almost perpendicular to the bone plate. In order to maintain equal thickness, the blade will be adjusted parallel to the surface after the necessary soft tissue thickness (about 1.5mm) is achieved. The graft will be held parallel to the external surface and de-epithelialized using a 15c blade. |
| Intervention |
ginigval unit graft |
Gingival unit graft (GUG) is a modified FGG which includes the marginal and papillary gingiva.The maxillary premolars palatal side will be used to harvest the gingival unit graft (GUG). A gingivectomy knife will be used to remove the palatal tissue, which includes the gingival edge and interpapillary area. A No.15c BP blade will be used to thin the tissue to about 1.5 mm. First, papillae will be removed by partial thickness connected by a sulcular incision. The No.15c blade will be used to remove the remaining graft to get rid of any loose tissue tags from bottom portion of the graft. The graft will be held parallel to the external surface and de-epithelialized using a 15c blade.Follow up period is set for 4 months for both the groups. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1) Recession type 2 (RT2)including incisors and premolars.
2)Individuals between the age group of 18-45, both male and female
3)Individuals who are systemically healthy.
4)Subjects whose Plaque index (PI) score is less than 1.9
|
|
| ExclusionCriteria |
| Details |
1.Patients who are smokers ( more than 10 cigarettes/day).
2.Patients who are not available for follow up.
3.Pregnant and Lactating mothers.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to asses Recession Width, Recession Depth,Volumetric change assessment,probing depth. |
baseline and after 4 months of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to asses probing depth,clinical attachment loss,complete root coverage in percentage,root coverage esthetic score. |
both at baseline and after 4 months of surgery. |
|
|
Target Sample Size
|
Total Sample Size="18"
Sample Size from India="18"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
16/11/2026 |
| 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="9"
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 unit graft (GUG) is a modified FGG which includes the marginal
and papillary gingiva. Findings consistently indicate that GUG offers superior
outcomes in terms of recession coverage, keratinized tissue gain, and aesthetic
outcomes compared to FGG. This is attributed to the rich vascular plexus and
anastomoses which perfuse marginal and papillary gingiva. The severed blood
vessels of recipient site anastomose rapidly with the rich plexus leading to superior
clinical results [3]. Based on these findings it was hypothesized
that de-epithelialized GUG could provide comparable results along with TCAF
(Tunneled coronally advanced flap) for RT2 recession. However, no studies have
specifically investigated the application of de-epithelialized GUG with TCAF in
treating RT2 defects.
Therefore, the
purpose of the research is to compare clinically, the effectiveness of
de-epithelialized Free gingival graft (FGG) to de-epithelialized gingival unit
grafts (GUG) in combination with TCAF for management of RT2 gingival recession.
|