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COMPLETED
NCT07716033
NA

Aesthetic and Functional Evaluation of a Universal One-Shade Composite in Primary Maxillary Incisors

Sponsor: Goa Dental College

View on ClinicalTrials.gov

Summary

* Use of tooth-coloured fillings is an essential part of Pediatric dentistry as most patients desire fillings which look like natural teeth. * Lately, there is a vast variety of shade-choices in filling materials which complicates colour matching procedure, increases cost and increases treatment time. * Universal One shade composite filling materials have been developed to overcome these disadvantages. Omnichroma (Tokuyama Dental, USA) is one such material, introduced in 2019. * Manufacturer claims that it can match colour of surrounding tooth, irrespective of its shade, which may be an advantage for patients as well as pediatric dentists. * In child patients where chairside time, child's cooperation are important, this new one shade filling material Omnichroma, may prove to be better than multi shade composite filling materials, regarding color matching, color stability and other functional properties. * There are very few studies on this new material, that have assessed its actual performance in patients, and more studies would be useful to generate scientific evidence for dentists to use. * In this study we will fill one of your child's decayed front tooth with the new One shade filling material Omnichroma, and the other decayed front tooth with the usual conventional multi shade filling material 3M Filtek Z350 after colour matching followed by evaluation and taking of intraoral photographs. * You would be required to report for follow ups at 3, 6 and 12 months interval for a repeat evaluation and intraoral pictures.

Official title: Evaluation of the Aesthetic and Functional Properties of A Universal One-Shade Composite Material With Chameleon-like Properties: A Longitudinal Split-Mouth Randomised Controlled Trial

Key Details

Gender

All

Age Range

3 Years - 5 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-03-01

Completion Date

2026-02-28

Last Updated

2026-07-21

Healthy Volunteers

Yes

Interventions

OTHER

Tokuyama Palfique Omnichroma composite restoration

Tokuyama Palfique Omnichroma is a universal one-shade resin composite used for direct restoration of primary maxillary incisors.

OTHER

3M Filtek Z350 composite restoration

3M Filtek Z350 XT is a nanofilled resin composite used as the active comparator for direct restoration of primary maxillary incisors.

Locations (1)

Goa Dental College and Hospital

Bambolim, Goa, India