| CTRI Number |
CTRI/2019/02/017482 [Registered on: 05/02/2019] Trial Registered Prospectively |
| Last Modified On: |
31/01/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing two fillings for teeth with soft enamel |
|
Scientific Title of Study
|
Comparative evaluation of a bioactive restorative material with resin modified glass ionomer cement for the restoration of molars affected by molar-incisor hypomineralisation- a split mouth 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 Kunal Bhatia |
| Designation |
Post Graduate |
| Affiliation |
Manipal College of Dental Sciences, Manipal |
| Address |
Room 6
Department of Pedodontics and Preventive Dentistry
Manipal College of Dental Sciences, Manipal
Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
9740604048 |
| Fax |
|
| Email |
kunalb.9993@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kunal Bhatia |
| Designation |
Post Graduate |
| Affiliation |
Manipal College of Dental Sciences, Manipal |
| Address |
Room 6
Department of Pedodontics and Preventive Dentistry
Manipal College of Dental Sciences, Manipal
Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
9740604048 |
| Fax |
|
| Email |
kunalb.9993@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rashmi Nayak |
| Designation |
Professor and Head of Department |
| Affiliation |
Manipal College of Dental Sciences |
| Address |
Room 6
Department of Pedodontics and Preventive Dentistry
Manipal College of Dental Sciences, Manipal
Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
9845364987 |
| Fax |
|
| Email |
rashmi.nayak@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Dental Sciences, Manipal |
|
|
Primary Sponsor
|
| Name |
Manipal College of Dental Sciences |
| Address |
Madhav Nagar, Eshwar Nagar
Manipal, Karnataka
576104 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kunal Bhatia |
Department of Pedodontics and Preventive Dentistry |
Manipal College of Dental Sciences
Madhav Nagar, Eshwar Nagar
Manipal
Udupi
KARNATAKA |
6362619166
kunalb.9993@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Molar-Incisor Hypomineralisation |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ACTIVAâ„¢ BioACTIVE-RESTORATIVEâ„¢ |
Manufactured by Pulpdent |
| Comparator Agent |
Resin Modified Glass Ionomer Cement (GC Light-Cured Universal Restorative) |
Manufactured by GC |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Bilateral permanent first molars, diagnosed with Severe Molar Incisor Hypomineralisation, as per Alaluusua’s criteria, in patients between ages 6 to 10, that are partially or completely erupted will be included in the study, after obtaining informed consent from the patient’s parents/guardians. |
|
| ExclusionCriteria |
| Details |
Permanent first molars with enamel hypoplasia associated with syndromes, dental fluorosis, those with destroyed crowns, carious lesions, and those which are hypomineralised on only one side of the dental arch will be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Colour match, anatomic contour, marginal integrity, cavosurface marginal discolouration, surface texture, secondary caries and gross fracture of the restoration |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Remineralisation in the tooth after placement of the bioactive restoration |
6 months |
|
|
Target Sample Size
|
Total Sample Size="43"
Sample Size from India="43"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
02/04/2019 |
| 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="2"
Months="0"
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)?
|
|
Brief Summary
|
The study involves restoration of permanent first molars in children with molar-incisor hypomineralisation, with a bioactive restorative materia (ACTIVA BioActive) and comparing its longevity and clinical performance with resin modified glass ionomer cement. Children aged 6-10 years, will be screened for MIH throughout the schools in Udupi, India. The ones diagnosed with severe MIH will be recruited in the study. Informed consent will be obtained from the parents prior to recruitment. Both the restorations will be assessed using United States Public Health Modified Ryge’s Criteria and will be followed up after 6 months. |