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CTRI Number  CTRI/2022/03/041319 [Registered on: 23/03/2022] Trial Registered Prospectively
Last Modified On: 21/03/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to compare new materials for restoration of class- II cavities. 
Scientific Title of Study   Clinical Performance of Reinforced Glass Ionomer Materials in Class-II Restorations - A 12 Month 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 AMIT KUMAR 
Designation  Post graduate student 
Affiliation  ARMY COLLEGE OF DENTAL SCIENCES 
Address  Department of Conservative Dentistry and Endodontics,(Room no 9) Army College of Dental Sciences, Jai Jawahar Nagar, CRPF-Chennapur road, Secunderabad, Hyderabad, TELANGANA Pin-500087 India

Hyderabad
TELANGANA
500087
India 
Phone  7988130624  
Fax    
Email  akmalik2601@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mamta Kaushik 
Designation  Professor and HOD 
Affiliation  ARMY COLLEGE OF DENTAL SCIENCES 
Address  Deparment of Conservative Dentistry and Endodontics (Room no 9) Army College of Dental Sciences, Jai Jawahar Nagar PO, CRPF-Chennapur road, Secunderabad,

Hyderabad
TELANGANA
500087
India 
Phone  9391010325  
Fax    
Email  mamkaushik@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mamta Kaushik 
Designation  Professor and HOD 
Affiliation  ARMY COLLEGE OF DENTAL SCIENCES 
Address  Deparment of Conservative Dentistry and Endodontics (Room no 9) Army College of Dental Sciences, Jai Jawahar Nagar PO, CRPF-Chennapur road, Secunderabad,

Mahbubnagar
TELANGANA
500087
India 
Phone  9391010325  
Fax    
Email  mamkaushik@gmail.com  
 
Source of Monetary or Material Support  
Department of Conservative Dentistry and Endodontics, Army College of Dental Sciences 
 
Primary Sponsor  
Name  Dr Amit Kumar 
Address  Deparment of Conservative Dentistry and Endodontics Room no 9 Army College of Dental Sciences, Jai Jawahar Nagar, CRPF-Chennapur road, Secunderabad, Hyderabad, Telangana 500087 India 
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 Amit Kumar  Army College of Dental Sciences  Department of Conservative Dentistry and Endodontics,(Room number 9) Army College of Dental Sciences, Jai Jawahar Nagar, Chennapur-CRPF Road, Secunderabad Hyderabad TELANGANA-500087
Hyderabad
TELANGANA 		 7988130624

akmalik2601@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Army College of Dental Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Class-II Dental Caries/ Reversible Pulpitis 
Patients  (1) ICD-10 Condition: K026||Dental caries on smooth surface,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Equia Forte HT (GC America)   EQUIA Forte HT is a long-term bulk fill glass hybrid restorative system with enhanced mechanical properties, superior fluoride release, sound marginal seal and excellent handling. This material would be used for restoring deep Class-II cavities. Time duration for each patient restoration would be approximately 45 minutes. 
Comparator Agent  Filtekâ„¢ Z350 XT Universal Restorative  Filtekâ„¢ Z350 XT Universal Restorative is a universal visible light-activated nano-composite designed for use in anterior and posterior restorations. It would be used for restoring deep Class-II cavities. Time duration for each patient restoration would be approximately 45 minutes.  
Intervention  Zirconomer Improved (Shofu Dental)   Zirconomer Improved a zirconia reinforced glass ionomer cement. It is strong, durable and fluoride rich bulk fill restorative for structural cores and bases as well as cases with high caries risk. It would be used for restoring deep Class-II cavities. Time duration for each patient restoration would be approximately 45 minutes. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Inclusion criteria:
1) Patients in the age group of 18-50 years.
2) Presence of adjacent and antagonist teeth.
3) Asymptomatic and vital teeth.
4) One or more proximal carious lesions in the posterior teeth.
5) A healthy periodontal status (absence of tooth mobility and absence of bleeding on probing)
6) Likelihood of recall availability. 
 
ExclusionCriteria 
Details  Exclusion Criteria:
1) Partially erupted teeth
2) Unhealthy periodontal status
3) Absence of adjacent and antagonist teeth.
4) Carious lesion <3mm depth.
5) Carious pulpal exposure
6) Past and fractured restorations
7) Patients suffering from xerostomia
8) Pregnant women  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Equia Forte HT and Zirconomer Improved may prove to be an effective substitute for amalgam in restoring deep Class-II cavities present in stress bearing areas.  Post restoration:
1 week (baseline)
3 months
6 months
12 months 
 
Secondary Outcome  
Outcome  TimePoints 
Clinical performance of each restorative material would be evaluated on the basis of following parameters:
1. Color Match
2. Marginal Discoloration
3. Anatomic Form
4. Contact Point
5. Marginal Adaptation
6. Retention
7. Secondary Caries
8. Surface Texture
9. Post-operative Sensitivity
 		 Post restoration:
1 week (baseline)
3 months
6 months
12 months 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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)   31/03/2022 
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="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   The aim of the study is to evaluate the clinical performance of two modified glass ionomers i.e glass hybrid restorative materials in comparison with a nanocomposite material in deep Class-II cavities using Modified USPHS criteria. . Seventy-five patients diagnosed with reversible pulpits(CLass-II carious lesions) in posterior teeth will be randomly divided into three groups: Group A- EQUIA FORTE HT, Group B- ZIRCONOMER IMPROVED and Group C- FILTEK Z350XT UNIVERSAL. All the patients will be subjected to Class-II cavity preparation followed by restoration. After the treatment, patients from each group would be recalled after one week (baseline), 3 months, 6 months, 12 months from the day of restoration to evaluate the restorations made using given different materialsusing MODIFIED USPHS CRITERIA under which following parameters would be evaluated:1. Color Match 2. Marginal Discoloration 3. Anatomic Form 4. Contact Point 5. Marginal Adaptation 6. Retention 7. Secondary Caries 8. Surface Texture 9. Post-operative Sensitivity. The data obtained, will be subjected to statistical analysis. 
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