Comparing two fillings for teeth with soft enamel

Not Applicable

Not yet recruiting

• Conditions: Molar-Incisor Hypomineralisation

• Registration Number: CTRI/2019/02/017482
• Lead Sponsor: Manipal College of Dental Sciences

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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2019-01-31
• Study Start: 2019-02-04

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Colour match, anatomic contour, marginal integrity, cavosurface marginal discolouration, surface texture, secondary caries and gross fracture of the restoration	6 months

Secondary Outcome Measures

Name	Time	Method
Remineralisation in the tooth after placement of the bioactive restoration	6 months

Trial Locations

Locations (1)

Department of Pedodontics and Preventive Dentistry; 🇮🇳 Udupi, KARNATAKA, India

Department of Pedodontics and Preventive Dentistry

🇮🇳Udupi, KARNATAKA, India

Dr Kunal Bhatia

Principal investigator

6362619166

kunalb.9993@gmail.com