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CTRI Number  CTRI/2021/08/035461 [Registered on: 05/08/2021] Trial Registered Prospectively
Last Modified On: 03/08/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to compare two tooth coloured filling materials. 
Scientific Title of Study   Comparative evaluation of periodontal health and clinical performance of Resin modified glass ionomer with a bioactive restorative material in non-carious cervical lesions.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  GAURI MALIK 
Designation  PROFESSOR 
Affiliation  CHRISTIAN DENTAL COLLEGE 
Address  DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS, CHRISTIAN DENTAL COLLEGE, BROWN ROAD, LUDHIANA, PUNJAB.

Ludhiana
PUNJAB
141008
India 
Phone  9217133366  
Fax    
Email  gaurimlk@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  GAURI MALIK 
Designation  PROFESSOR 
Affiliation  CHRISTIAN DENTAL COLLEGE 
Address  DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS, CHRISTIAN DENTAL COLLEGE, BROWN ROAD, LUDHIANA, PUNJAB.


PUNJAB
141008
India 
Phone  9217133366  
Fax    
Email  gaurimlk@gmail.com  
 
Details of Contact Person
Public Query  
Name  GAURI MALIK 
Designation  PROFESSOR 
Affiliation  CHRISTIAN DENTAL COLLEGE 
Address  DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS, CHRISTIAN DENTAL COLLEGE, BROWN ROAD, LUDHIANA, PUNJAB.


PUNJAB
141008
India 
Phone  9217133366  
Fax    
Email  gaurimlk@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  CHRISTIAN DENTAL COLLEGE 
Address  CHRISTIAN DENTAL COLLEGE, BROWN ROAD, LUDHIANA, PUNJAB 
Type of Sponsor  Private hospital/clinic 
 
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 
GAURI MALIK  CHRISTIAN DENTAL COLLEGE  DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS, CHRISTIAN DENTAL COLLEGE, LUDHIANA, PUNJAB.
Ludhiana
PUNJAB 		 9217133366

gaurimlk@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
THE INSTITUTIONAL ETHICS COMMITTEE OF CHRISTIAN MEDICAL COLLEGE AND HOSPITAL, LUDHIANA, PUNJAB  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  non-carious cervical lesions in maxillary teeth 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Activa Bioactive, Pulpdent, USA  Activa Bioactive restorative (Pulpdent,USA) is a restorative material which comprises of a patented bioactive shock-absorbing rubberized ionic-resin (Embrace resin) matrix that contains a small amount of water. It contains no Bisphenol A, Bis-GMA or BPA 3 derivatives. In this study Activa will be used in non-carious cervical lesions(NCCL) of maxillary teeth, followed by evaluation of periodontal health of restored teeth for 18 months. 
Comparator Agent  Resin modified Glass Ionomer (GC)   Resin modified Glass ionomer (RMGIC) incorporate a resin matrix (hydrophilic monomers, such as hydroxyethylmethacrylate (​HEMA) and polymerization initiators) into GICs. In this study, it is used in non-carious cervical lesions (NCCL) of maxillary teeth, followed by evaluation of periodontal health of restored teeth for 18 months. 
 
Inclusion Criteria  
Age From  29.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  •Bilateral non carious cervical lesions in
Maxillary arch
•Age group- 29-65 years
•Etiology: Abrasive toothpaste and faulty brushing
technique
•Periodontally healthy teeth
 
 
ExclusionCriteria 
Details  •Patient with systemic disorder or under
antibiotic or anti-inflammatory therapy
•Traumatic occlusion
•Parafunctional habits or anomalies like high
frenal attachment

 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Periodontal health of non–carious cervical lesions in teeth restored with RMGI(Light cured GIC) and a bioactive restorative material(Activa Bioactive) upto 18 months.
2.Marginal adaptation of the restorations upto 18 months 		 3months
6months
12months
18months 
 
Secondary Outcome  
Outcome  TimePoints 
Post operative sensitivity, surface texture, contour, marginal discolouration, recurrent caries in restored teeth.  3months
6months
12months
18months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 
Date of First Enrollment (India)   10/08/2021 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   It is a randomized interventional clinical study conducted on 30 periodontally healthy patients with split-mouth approach comparing the periodontal health and clinical performance of Resin modified glass ionomer with Activa bioactive restorative material in non-carious cervical lesions and the patients will be followed up for 18 months. 
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