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OpenTrials
Completed

NCT Number: NCT07716033

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

* 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.

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Key information

Age range

3 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Goa Dental College and Hospital

Bambolim, Goa, 403202, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tokuyama Palfique Omnichroma composite restoration

Other

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

3M Filtek Z350 composite restoration

Other

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Goa Dental College

Other Gov

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 21, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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