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Comparing two fillings for teeth with soft enamel

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/02/017482
Enrollment
43
Registered
2019-02-05
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: ACTIVAâ?¢ BioACTIVE-RESTORATIVEâ?¢: Manufactured by Pulpdent Control Intervention1: Resin Modified Glass Ionomer Cement (GC Light-Cured Universal Restorative): Manufactured by GC

Sponsors

Manipal College of Dental Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Bilateral permanent first molars, diagnosed with Severe Molar Incisor Hypomineralisation, as per Alaluusuaâ??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 patientâ??s parents/guardians.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Colour match, anatomic contour, marginal integrity, cavosurface marginal discolouration, surface texture, secondary caries and gross fracture of the restorationTimepoint: 6 months

Secondary

MeasureTime frame
Remineralisation in the tooth after placement of the bioactive restorationTimepoint: 6 months

Countries

India

Contacts

Public ContactDr Rashmi Nayak

Manipal College of Dental Sciences, Manipal

kunalb.9993@gmail.com9740604048

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026