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CTRI Number  CTRI/2020/05/024978 [Registered on: 01/05/2020] Trial Registered Prospectively
Last Modified On: 14/09/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   Treatment of gingival recession using two different soft tissue graft procedures: a comparative study 
Scientific Title of Study   Comparative clinical evaluation of gingival unit grafts and epithelialized palatal grafts ( free gingival grafts) in the treatment of gingival recession: A randomised controlled clinical trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrNeelima Katti 
Designation  Assistant Professor 
Affiliation  SCB dental college and Hospital 
Address  Department of periodontics, 3rd floor
Manglabag
Cuttack
ORISSA
753007
India 
Phone  09337613446  
Fax    
Email  kattineelima@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrNeelima Katti 
Designation  Assistant Professor 
Affiliation  SCB dental college and Hospital 
Address  Department of periodontics, 3rd floor
Manglabag
Cuttack
ORISSA
753007
India 
Phone  09337613446  
Fax    
Email  kattineelima@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrNeelima Katti 
Designation  Assistant Professor 
Affiliation  SCB dental college and Hospital 
Address  Department of Periodontics, 3rd floor
Manglabag
Cuttack
ORISSA
753007
India 
Phone  09337613446  
Fax    
Email  kattineelima@gmail.com  
 
Source of Monetary or Material Support  
self funding. Dr.Neelima katti,Department of Peridontics, SCB dental College and Hospital , 3rd floor Cuttack,753007 
 
Primary Sponsor  
Name  Dr Neelima Katti 
Address  Department of Peridontics, SCB dental College and Hospital , 3rd floor Cuttack,753007 
Type of Sponsor  Other [self] 
 
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 
DrNeelima Katti  SCB dental college and hospital  Department of Periodontology, 3rd floor manglabag,cuttack
Cuttack
ORISSA 
9337613446

kattineelima@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethics committe (IEC), scb dental college and hospital, cuttack, odisha  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  gingival recession in mandibular teeth, belonging to Millers classification, class 1 and class 2 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  free gingival graft  palatal graft harvested 2mm away from adjacent gingival margin, followed up for a period of 12 months. 
Intervention  gingival unit graft  palatal graft involving adjacent marginal and free , followed up for a period of 12 months 
 
Inclusion Criteria  
Age From  18.00 Day(s)
Age To  60.00 Day(s)
Gender  Both 
Details  Miller’s class 1 and class 2 bilateral recessions, ≥ 3mm on buccal aspects of premolars, canines and lateral incisors, in systemically healthy patients. 
 
ExclusionCriteria 
Details  Poor oral hygiene (plaque score >20%
Smokers
Pregnancy
Root surface restorations, caries, endodontic treatment
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
percentage of root coverage achieved at the end of 12 months  At the end of 12 months 
 
Secondary Outcome  
Outcome  TimePoints 
width of keratinised gingiva
esthetic score
healing of donor site 
12 months 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="22" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/05/2020 
Date of Study Completion (India) 10/03/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Comparative clinical evaluation of gingival unit grafts and epithelialized palatal grafts in the treatment of gingival recession: A randomised controlled clinical trial 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [kattineelima@gmail.com].

  6. For how long will this data be available start date provided 30-10-2021 and end date provided 30-10-2024?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  

 

 

 

 

 

Comparative clinical evaluation of gingival unit grafts and epithelialized palatal grafts ( free gingival grafts)  in the treatment of gingival recession: A randomised controlled  clinical trial

 

 

 

 

 

 

 

 

 

 

 

Introduction:

Gingival recession is one of the most common manifestations of periodontal diseases. The treatment modalities commonly employed to treat gingival recession sites range from free soft tissue autografts , sub epithelial connective tissue grafts, pedicle grafts, soft tissue replacement materials like collagen, alloderm, amniotic membrane etc. Epithelialized palatal grafts (EPG) more popularly known as free gingival grafts are harvested from the palate, at a distance of 2mm from the adjacent gingival margin. EPG though relies on the advantage of tissue transplant from a functionally similar site , has low predictability in its use for root coverage procedure and does not sufficiently replace the esthetics at the recipient area. Gingival unit transfer is an autogenous procedure, used in coverage of denuded roots wherein the graft harvested includes gingival margin along with the keratinised epithelium from the palate, so that the graft morphology and histology resembles the missing structures at the recipient site. The unique and complex vasculature of marginal tissue with its rich anastomosis  improves the chances for graft survival on avascular root surface and increases its predictability for use in root coverage procedures.

Review of literature:

1. Gingival Unit Graft Versus Free Gingival Graft for Treatment of Gingival Recession: A Randomized Controlled Clinical Trial Jenabian et al 2016

In this randomized controlled clinical trial with split mouth design, the authors concluded that gingival unit graft might be an acceptable modality in Miller Class I/II recession defects with advantages over free gingival graft such as significantly superior clinical and esthetic results.

2. Treatment of Localized Gingival Recessions Using Gingival Unit Grafts: A Randomized Controlled Clinical Trial. Kuru B, Yıldırım S 2013

The authors concluded that gingival unit grafts can be used  as an alternative technique for treating buccal gingival recessions with better defect coverage, clinical, and esthetic improvements compared with palatal grafts.

 

3. Gingival unit transfer using in the Miller III recession defect treatment. Selin Yıldırım and Bahar Kuru 2015

In this case report the clinical effectiveness of gingival unit transfer (GUT) technique performed on Miller III recession was presented and a similar recession case treated with free gingival graft (FGG) technique for comparison. The GUT revealed better defect coverage and creeping attachment results than the FGG in the treatment of Miller III defects.

 

4. Use of the gingival unit transfer in soft tissue grafting: report of three cases. Allen AL 2004

The gingival unit transfer is introduced through three case reports that describe its use for root coverage and replacement of intact but pathologically involved or esthetically compromised papillae. Supracrestal gingiva, used as a free graft for the above purposes, may have an uncommon capacity for perfusion and survival.

 

Aims and objectives:

1.     To compare the use of Gingival unit transfer with epithelialized palatal graft as a surgical modality for the treatment of localised Miller’s class I and class II gingival recession defects over a six month period.

2.     

 

Justification for study

Gingiva with its unique vasculature is naturally created to survive and function interproximally and facially over avascular root surfaces. Gingival unit graft, used as a free graft for recession coverage may have an uncommon capacity for perfusion and survival. More investigation is necessary to confirm the validity of this concept.

Methodology:

Bilateral sites in 22 patients with miller’s class 1 and class 2 recession, will be randomly assigned to recieve epithelialized palatal graft or gingival unit grafts. Plaque and gingival index will be scored at baseline after scaling, at 4 weeks and subsequently at every post surgical visit of the patient. Post surgery ,the patients will be recalled every two weeks for the first two months and once every month thereafter for six months. Recession depth, recession width, probing depth, keratinised gingiva width, clinical attachment level both at donor and recipient site will be recorded at baseline 1 month, 3 months and six months.Supra gingival polishing at each of these visits may be done as required. 

Potential risks & benefits:

Gingival unit graft technique is relatively safer when compared to the free gingival graft as it is at a more safer distance from greater palatine artery.

 


 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
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