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CTRI Number  CTRI/2022/11/047783 [Registered on: 30/11/2022] Trial Registered Prospectively
Last Modified On: 30/11/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Treatment of receding gums using two different material. 
Scientific Title of Study   clinical outcomes of modified coronally advanced tunnel technique using sub-epithelial connective tissue graft , xenogenic collagen matrix (XCM) and XCM with injectable platelet rich fibrin in the treatment of RT1 gingival recession : A three arm randomized 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  Dr Supriya Mishra 
Designation  consultant 
Affiliation  Government Dental College , Raipur 
Address  Department of periodontics, GDC Raipur

Raipur
CHHATTISGARH
492001
India 
Phone    
Fax    
Email  dr.supriya4@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Supriya Mishra 
Designation  consultant 
Affiliation  Government Dental College , Raipur 
Address  Department of periodontics, GDC Raipur

Raipur
CHHATTISGARH
492001
India 
Phone    
Fax    
Email  dr.supriya4@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Supriya Mishra 
Designation  Post Graduate Student 
Affiliation  Government Dental College , Raipur 
Address  Department of Periodontics, GDC raipur

Raipur
CHHATTISGARH
492001
India 
Phone    
Fax    
Email  dr.supriya4@gmail.com  
 
Source of Monetary or Material Support  
Bhilai dental clinic and Hospital 
 
Primary Sponsor  
Name  other 
Address  bhilai dental clinic, sector 4 bhilai  
Type of Sponsor  Other [clinician] 
 
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 Supriya Mishra  bhilai dental clinic  sector 4, bhilai
Durg
CHHATTISGARH 
8889651606

dr.supriya4@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethics committee, maitri college of dentistry and research center, anjora, durg  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  gingival recession  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  modified coronally advanced tunnel technique with i-prf and xenogenic collagen matrix  modified coronally advanced tunnel technique with i-prf and xenogenic collagen matrix in the treatment of gingival recession 
Comparator Agent  modified coronally advanced tunnel technique with xenogenic collagen matrix alone and SCTG  modified coronally advanced tunnel technique with xenogenic collagen matrix alone and Sub epithelial connective tissue graft  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  Patient with age of ≥18 years.
Presence of bilateral Miller’s class I (Marginal tissue recession, which does not extend to the mucogingival junction (MGJ)) / class II (Marginal tissue recession extending to or beyond mucogingival junction(MGJ)) gingival recession of same depth on buccal aspect of anterior teeth and premolars with no radiographic sign of bone loss and requiring surgical intervention for root coverage,
Probing pocket depth <3mm,
No prior history of any surgical procedures on the site to be treated,
Presence of detectable CEJ,
Not using tobacco in any form,
Systemically healthy subjects with no contraindication to periodontal surgery,
Able to achieve good oral hygiene and control gingivitis in the whole of the dentition (FMPS<10% and FMBS<10%)
Patient willing to undergo surgical procedure and giving written informed consent
 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
modified Coronally advanced tunnel flap with xenogeneic collagen matrix (XCM) and i-prfto be similarly effective as coronally advanced flap with sub-epithelial connective tissue graft (SCTG) in root coverage procedures in terms of recession depth (RD) and percentage root coverage (RC) at baseline, 1 week, 6 months  modified Coronally advanced tunnel flap with xenogeneic collagen matrix (XCM) and i-prfto be similarly effective as coronally advanced flap with sub-epithelial connective tissue graft (SCTG) in root coverage procedures in terms of recession depth (RD) and percentage root coverage (RC) at baseline, 1 week, 6 months. 
 
Secondary Outcome  
Outcome  TimePoints 
relative attachment level, keratinized tissue height, keratinized tissue thickness , recession width and root coverage esthetic score in patients treated with XCM and iprf when compared to patients treated with SCTG and XCM only  at 6 months 
 
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   N/A 
Date of First Enrollment (India)   30/11/2022 
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="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

         There are various surgical techniques and their modifications for the treatment of gingival recession. These include pedicle grafts (lateral sliding or double papillae) with or without connective tissue grafts, epithelised autogenous grafts (free gingival), sub-epithelial connective tissue grafts (SCTG), coronally advanced flaps (CAF) alone, CAF preceded by a free gingival graft, and CAF with a simultaneous SCTG.

         SCTG helps in improved long-term stability of complete root coverage (CRC) and it is accepted as the gold standard in the treatment of gingival recessions. However, the requirement of a second surgical site, limited amount of graft, rather low patient tolerance and high complication rates in donor area are the major disadvantages of SCTG.

         To reduce these disadvantages, barrier membrane, platelet-rich plasma, platelet-rich fibrin, enamel matrix derivatives and graft substitute materials have been used as an alternative to SCTG. But studies have shown that only SCTG in conjunction with CAF was able to enhance the ability to achieve complete root coverage and to improve recession reduction.

         Human acellular dermal matrix (ADM) was introduced as SCTG substitute with various surgical techniques aiming root coverage but no additional benefit over CAF+SCTG was found. Additionally, there is a possible risk for disease transmission as it is derived from cadavers which limited the use of this material.

         Recently, a new bi-layer xenogeneic collagen matrix (XCM) has been used in periodontal regenerative procedures. XCM is composed of a cell occlusive layer with compact collagen fibre and a spongious layer with porous collagen structure. This porous layer provides stabilization of blood clot and necessary space that helps in cell migration and might increase the formation of keratinized tissue. Hence, XCM seems to be a promising soft tissue graft substitute when used with CAF. It is not only less invasive and time consuming but also provides unlimited off-the-shelf supply of graft material and has been cleared by U S Food and Drug Administration (FDA).

Injectable platelet-rich fibrin (i-PRF) has been produced by changing the type of the tube, centrifugation time and speed; specifically, the blood is centrifuged in plastic tubes at 700 rpm for 3 min (Miron & Choukroun, 2017). I-PRF prepared according to low-speed centrifugation concept can provide a significant advantage for the regeneration process, as it is rich in platelets, leucocytes and growth factors (Choukroun & Ghanaati,2018).

 
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