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

July 15, 2026 updated by: Ruhi Sanvordekar, Goa Dental College

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

  • 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Goa
      • Bambolim, Goa, India, 403202
        • Goa Dental College and Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Universal One-shade composite group
Other: Tokuyama Palfique Omnichroma composite restoration
Tokuyama Palfique Omnichroma is a universal one-shade resin composite used for direct restoration of primary maxillary incisors.
Active Comparator: Conventional Multi-shade composite
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surface Luster and Surface texture
Time Frame: Baseline, 3 months, 6 months, and 12 months
Assessed using Revised FDI criteria 2023 Scores from 1-5 Higher scores indicate inferior outcome
Baseline, 3 months, 6 months, and 12 months
Marginal adaptation
Time Frame: Baseline, 3 months, 6 months, 12 months
Assessed using Revised FDI criteria 2023 Scores from 1-5 Higher scores indicate inferior outcome
Baseline, 3 months, 6 months, 12 months
Marginal staining
Time Frame: Baseline, 3 months, 6 months, 12 months
Assessed using Revised FDI criteria 2023 Scores from 1-5 Higher scores indicate inferior outcome
Baseline, 3 months, 6 months, 12 months
Fracture of material and retention
Time Frame: Baseline, 3 months, 6 months, 12 months
Assessed using Revised FDI criteria 2023 Scores from 1-5 Higher scores indicate inferior outcome
Baseline, 3 months, 6 months, 12 months
Colour match
Time Frame: Baseline, 3 months, 6 months, 12 months
Assessed using Revised FDI criteria 2023 Scores from 1-5 Higher scores indicate inferior outcome
Baseline, 3 months, 6 months, 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Photographic/Digital Colour match
Time Frame: Baseline, 3 months, 6 months, 12 months
A software was used to provide CIE L*, a*, and b* values for one point over the tooth surface (Pt B) and one point over the restoration (Pt A). The colour match/difference (ΔE) between the restoration (Pt A) and the adjacent tooth structure (Pt B) was calculated using the CIEDE2000 colour difference formula through the software algorithm. Lower ΔE values indicate a smaller colour discrepancy between the restoration and the surrounding tooth structure and were interpreted as better colour matching. Higher ΔE values indicate greater perceptible colour differences.
Baseline, 3 months, 6 months, 12 months
Photographic/ Digital Colour stability
Time Frame: Baseline, 3 months, 6 months, 12 months
For the assessment of colour stability, ΔE values obtained at different follow-up intervals were compared over time at baseline (ΔE0), 3 months (ΔE₁), 6 months (ΔE₂) and 12 months (ΔE₃). Small differences in ΔE values across these time points were interpreted as indicating greater colour stability.
Baseline, 3 months, 6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Goa Dental College

Investigators

  • Principal Investigator: Ruhi Sanvordekar, MDS, Goa Dental College and Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2025

Primary Completion (Actual)

February 28, 2026

Study Completion (Actual)

February 28, 2026

Study Registration Dates

First Submitted

July 9, 2026

First Submitted That Met QC Criteria

July 15, 2026

First Posted (Actual)

July 21, 2026

Study Record Updates

Last Update Posted (Actual)

July 21, 2026

Last Update Submitted That Met QC Criteria

July 15, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GDCH/IEC/II-2024(18)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Only summary study results will be made publicly available. Individual participant data and participant identifiers will not be shared to maintain confidentiality.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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