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CTRI Number  CTRI/2025/04/084878 [Registered on: 16/04/2025] Trial Registered Prospectively
Last Modified On: 11/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Treating Receding Gums: A Comparison of Two Surgical Techniques Using Gum Tissue Grafts 
Scientific Title of Study   Comparative evaluation of de-epithelialized gingival unit graft (d-GUG) using modified bridge flap technique and de-epithelialized gingival unit graft (d-GUG) alone in management of gingival recession - A randomized controlled 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 Talari Satwika  
Designation  Post Graduate Student 
Affiliation  Kamineni Institute of Dental Sciences 
Address  Department of Periodontics first floor room number 6 Sreepuram Narketpally
Department of Periodontics first floor room number 6 Sreepuram Narketpally
Nalgonda
TELANGANA
508254
India 
Phone  7816066143  
Fax  08682272296  
Email  satwikatalari7@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Suryakanth Malgikar 
Designation  Professor 
Affiliation  Kamineni Institute of Dental Sciences 
Address  Department of Periodontics first floor room number 6 Sreepuram Narketpally
Department of Periodontics first floor room number 6 Sreepuram Narketpally
Nalgonda
TELANGANA
508254
India 
Phone  9591212165  
Fax  08682272296  
Email  drmalgikarsuryakanth@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Suryakanth Malgikar 
Designation  Professor 
Affiliation  Kamineni Institute of Dental Sciences 
Address  Department of Periodontics first floor room number 6 Sreepuram Narketpally
Department of Periodontics first floor room number 6 Sreepuram Narketpally
Nalgonda
TELANGANA
508254
India 
Phone  9591212165  
Fax  08682272296  
Email  drmalgikarsuryakanth@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  SELF  
Address  Kamineni Institute of Dental Sciences Department of Periodontics first floor room number 6 Sreepuram Narketpally - 508254 Nalgonda District Telangana India  
Type of Sponsor  Other [NIL] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Talari Satwika  Kamineni Institute of Dental Sciences  Department of Periodontics First Floor Room Number six Sreepuram Narketpally
Nalgonda
TELANGANA 		 7816066143
08682272296
satwikatalari7@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Individuals with gingival recessions will be recruited 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  de epithelized gingival unit graft along with modified bridge flap technique  GROUP I (TEST): 15 sites will be treated by de epithelized gingival unit graft (d-GUG) along with modified bridge flap technique. GROUP II (CONTROL): 15 sites will be treated by de epithelized gingival unit graft (d-GUG) alone. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Individuals from 18 to 50 years
Single/two adjacent teeth with miller’s class I or class II gingival recession defects
Teeth with identifiable Cemento Enamel Junction (CEJ)
Nonsmoker
 
 
ExclusionCriteria 
Details  Prominent root surface
Presence of anatomic factors such as shallow vestibule/inadequate keratinized gingiva or aberrant frenum which might impair passive coronal positioning of the flap
Presence of non-carious cervical lesions or root caries
Pregnant patients
Patients with systemic conditions
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Alternation 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the root coverage by using de-epithelialized gingival unit graft with modified bridge flap technique
To evaluate the root coverage by using de-epithelialized gingival unit graft alone
To compare the outcome of both the techniques
 		 To evaluate the root coverage by using de-epithelialized gingival unit graft with modified bridge flap technique
To evaluate the root coverage by using de-epithelialized gingival unit graft alone
To compare the outcome of both the techniques at baseline 4 weeks and 12 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 2 
Date of First Enrollment (India)   30/07/2025 
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="11"
Days="29" 
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  
Gingival recession is a condition where the denudation of root surfaces occurs due to the relocation of the gingival margin apical to the cement-enamel junction (CEJ), leading to root hypersensitivity and aesthetic problems.
AIM OF THE STUDY The aim of present study is to evaluate and compare soft tissue parameters and root coverage using de epithelized gingival unit graft (d-GUG) along with modified bridge flap technique and de epithelized gingival unit graft (d-GUG) alone in Gingival Recession.
OBJECTIVES OF THE STUDY: To evaluate the root coverage by using de-epithelialized gingival unit graft with modified bridge flap technique. To evaluate the root coverage by using de-epithelialized gingival unit graft alone.
GROUP I (TEST): 15 sites will be treated by de epithelized gingival unit graft (d-GUG) along with modified bridge flap technique. 
GROUP II (CONTROL): 15 sites will be treated by de epithelized gingival unit graft (d-GUG) alone.
Following clinical parameters will be measured using University of North Carolina (UNC) – 15 and assessed at baseline, 1 month and 3 months. Customized acrylic stents for each patient, with grooves corresponding to mid buccal surface of defects will be made to ensure accurate readings. Recession depth (RD) – the distance between cementoenamel junction (CEJ) and most apical portion of the gingival   margin. Recession width (RW) – width of recession defect at the level of CEJ. Probing depth (PD) – distance from the gingival margin to bottom of the gingival sulcus. Thickness of keratinized tissue (KTT) – determined at a distance of 1.5 mm apical to gingival margin using short anesthesia needle and rubber disc stopper.

 
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