* 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
Tokuyama Palfique Omnichroma is a universal one-shade resin composite used for direct restoration of primary maxillary incisors.
3M Filtek Z350 XT is a nanofilled resin composite used as the active comparator for direct restoration of primary maxillary incisors.
Goa Dental College and Hospital
Bambolim, Goa, India
Surface Luster and Surface texture
Assessed using Revised FDI criteria 2023 Scores from 1-5 Higher scores indicate inferior outcome
Time frame: Baseline, 3 months, 6 months, and 12 months
Marginal adaptation
Assessed using Revised FDI criteria 2023 Scores from 1-5 Higher scores indicate inferior outcome
Time frame: Baseline, 3 months, 6 months, 12 months
Marginal staining
Assessed using Revised FDI criteria 2023 Scores from 1-5 Higher scores indicate inferior outcome
Time frame: Baseline, 3 months, 6 months, 12 months
Fracture of material and retention
Assessed using Revised FDI criteria 2023 Scores from 1-5 Higher scores indicate inferior outcome
Time frame: Baseline, 3 months, 6 months, 12 months
Colour match
Assessed using Revised FDI criteria 2023 Scores from 1-5 Higher scores indicate inferior outcome
Time frame: Baseline, 3 months, 6 months, 12 months
Photographic/Digital Colour match
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.
Time frame: Baseline, 3 months, 6 months, 12 months
Photographic/ Digital Colour stability
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.
Time frame: Baseline, 3 months, 6 months, 12 months
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