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CTRI Number  CTRI/2023/01/049317 [Registered on: 31/01/2023] Trial Registered Prospectively
Last Modified On: 30/01/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   A clinical trial to compare the efficacy of Porcine collagen matrix and chorion membrane in gums receding defects.  
Scientific Title of Study   A COMPARATIVE EVALUATION OF THE EFFICACY OF PORCINE COLLAGEN MATRIX AND CHORION MEMBRANE USING CORONALLY ADVANCED FLAP TECHNIQUE FOR ROOT COVERAGE IN MULTIPLE ADJACENT MILLER’S CLASS I AND CLASS II GINGIVAL RECESSION- A 24 WEEKS CLINICAL STUDY  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr priya Sharma 
Designation  POST GRADUATE IN PERIODONTOLOGY 
Affiliation  INDERPRASTHA DENTAL COLLEGE AND HOSPITAL 
Address  DEPARTMENT OF PERIODONTOLOGY,ROOM NO 2, SECOND FLOOR, INDERPRASTHA DENTAL COLLEGE AND HOSPITAL, 46/1, SAHIBABAD INDUSTRIAL AREA, SITE 4, GHAZIABAD, UTTAR PRADESH

Ghaziabad
UTTAR PRADESH
201005
India 
Phone  09953321529  
Fax    
Email  drpriya1989@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR VIKRAM BLAGGANA 
Designation  HEAD OF DEPARTMENT AND PROFESSOR 
Affiliation  INDERPRASTHA DENTAL COLLEGE AND HOSPITAL 
Address  DEPARTMENT OF PERIODONTOLOGY,ROOM NO 2, SECOND FLOOR, INDERPRASTHA DENTAL COLLEGE AND HOSPITAL, 46/1, SAHIBABAD INDUSTRIAL AREA, SITE 4, GHAZIABAD, UTTAR PRADESH

Ghaziabad
UTTAR PRADESH
201010
India 
Phone  9811773797  
Fax    
Email  drblaggana@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR PREETI UPADHYAY 
Designation  PROFESSOR 
Affiliation  INDERPRASTHA DENTAL COLLEGE AND HOSPITAL 
Address  DEPARTMENT OF PERIODONTOLOGY,ROOM NO 2, SECOND FLOOR, INDERPRASTHA DENTAL COLLEGE AND HOSPITAL, 46/1, SAHIBABAD INDUSTRIAL AREA, SITE 4, GHAZIABAD, UTTAR PRADESH

Ghaziabad
UTTAR PRADESH
201010
India 
Phone  9910012441  
Fax    
Email  preeti.mynk@gmail.com  
 
Source of Monetary or Material Support  
INDERPRASTHS DENTAL COLLEGE AND HOSPITAL, 46/1, SAHIBABAD INDUSTRIAL AREA, SITE 4 GHAZIABAD, UTTAR PARDESH 
 
Primary Sponsor  
Name  DR PRIYA SHARMA 
Address  DEPARTMENT OF PERIODONTOLOGY,ROOM NO 2, SECOND FLOOR, INDERPRASTHA DENTAL COLLEGE AND HOSPITAL, 46/1, SAHIBABAD INDUSTRIAL AREA, SITE 4, GHAZIABAD, UTTAR PRADESH 
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 
DR PRIYA SHARMA  INDERPRASTHA DENTAL COLLEGE AND HOSPITAL  DEPARTMENT OF PERIODONTOLOGY,ROOM NO 2, SECOND FLOOR
Ghaziabad
UTTAR PRADESH 		 09953321529

drpriya1989@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K060||Gingival recession,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  CHORION MEMBRANE   Chorion membrane is a lyophilised(freeze-dried)gamma irradiated membrane in the size 2 x 2 sq. cm placed over the recession area during surgical procedure only. It is a 24 weeks study.  
Intervention  PORCINE COLLAGEN MEMBRANE   GeistlichMucograftTM is a resorbable porcine collagen matrix manufactured into a bilayered structure designed for periodontal soft tissue augmentation. It is a 24 weeks study. 
 
Inclusion Criteria  
Age From  22.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Patients maintaining good oral hygiene with plaque index (PI) (Score <1.0).
Patients willing to participate in the study and ready to give written consent.
Systemically healthy patients with multiple sites having Miller’s Class I and Class II recession and those who can understand and follow oral hygiene instructions properly.
 
 
ExclusionCriteria 
Details  Debilitating systemic or infectious diseases (HIV or hepatitis) or any other diseases that affect the periodontium.
A known allergy to any of the material used in the study
Poor compliance or failure to maintain good oral hygiene.
Pregnancy or lactation
Use of tobacco product through smoking or a smokeless tobacco habit.
Patients taking immunosuppressive drugs or corticosteroids which may compromise the treatment outcome.
History of previous root coverage procedure, graft or GTR involving the recession site.
Failure to sign the informed consent.
Patient under anticoagulant treatment or having any bleeding disorder.
Patient with recent account of dental or periodontal surgery in a span of 6 months.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
CLINICAL PARAMETERS OF PLAQUE INDEX, GINGIVAL INDEX, PROBING DEPTHS, GINGIVAL THICKNESS, WIDTH OF ATTACHED GINGIVA, CLINICAL ATTACHMENT LEVEL, RECESSION DEPTH  BASELINE,12 WEEKS AND 24 WEEKS 
 
Secondary Outcome     
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)   01/02/2023 
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="1"
Days="30" 
Recruitment Status of Trial (Global)   Not Applicable 
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   Gingival recession (GR) is the term that designates the oral exposure of the root surface due a displacement of the gingival margin apical to the cemento-enamel junction (CEJ). It is the most common and undesirable condition of the gingiva and its prevalence commonly increases with age. GR either localized or generalized, is one of the clinical features of periodontal disease and is frequently associated with clinical problems such as root surface hypersensitivity, root caries, cervical root abrasion, erosion, plaque retention and aesthetic dissatisfaction. The etiology is multifactorial and includes excessive or inadequate tooth brushing, destructive periodontal disease, tooth malposition, alveolar bone dehiscence, aberrent frenal pull, occlusal trauma, iatrogenic factors.
Various root coverage procedures are pedicle grafts, free gingival grafts, connective tissue grafts and membrane barrier guided tissue regeneration technique. In this study we will be comparing chorion membrane with Porcine collagen matrix with coronally advanced technique.
 
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