Aesthetic and Functional Evaluation of a Universal One-Shade Composite in Primary Maxillary Incisors | NCT07716033

NCT07716033

Overview

NCT ID: NCT07716033
Lead Sponsor: Goa Dental CollegeOTHER_GOV
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
Brief 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.

Status and Timeline

Status: Completed
Last Update Posted: Jul 21, 2026Actual
Start Date: Mar 1, 2025Actual
Primary Completion Date: Feb 28, 2026Actual
Completion Date

Participation Criteria

Ages Eligible for Study: Child (0-17)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: Inclusion Criteria:

Age group of 3-5 years

Carious lesions in both primary maxillary central incisors involving enamel or enamel and dentin only

Similar extent of carious lesion in both primary maxillary central incisors

Willing to give informed consent

Willing to return for evaluations and follow up

Exclusion Criteria:

Presence of pre shedding mobility

Deep carious lesions

Signs or symptoms of pulpal involvement

Presence of abscess, sinus tract, root resorption

Highly uncooperative patients

Medically compromised patients

Children with special health care needs

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 30Actual
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Contacts and Locations

Central Contacts: No data available
Locations: Goa Dental College and Hospital

Overview

Status and Timeline

Participation Criteria

Study Plan

Contacts and Locations

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