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

NCT07716033 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-07-21

No results posted yet for this study

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.

Conditions

  • Early Childhood Caries (ECC)

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.

Sponsors & Collaborators

  • Goa Dental College

    lead OTHER_GOV

Principal Investigators

  • Ruhi Sanvordekar, MDS · Goa Dental College and Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2026-02-28
Completion
2026-02-28

Countries

  • India

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07716033 on ClinicalTrials.gov