Early Childhood Caries (ECC)
Conditions
Keywords
Omnichroma, Universal one-shade composite, Colour match, Colour stability, Aesthetic, Functional
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.
Interventions
OTHERTokuyama Palfique Omnichroma composite restoration
Tokuyama Palfique Omnichroma is a universal one-shade resin composite used for direct restoration of primary maxillary incisors.
OTHER3M 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
Goa Dental College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Split-mouth Randomised controlled trial
Eligibility
Sex/Gender
ALL
Age
3 Years to 5 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surface Luster and Surface texture | Baseline, 3 months, 6 months, and 12 months | Assessed using Revised FDI criteria 2023 Scores from 1-5 Higher scores indicate inferior outcome |
| Marginal adaptation | Baseline, 3 months, 6 months, 12 months | Assessed using Revised FDI criteria 2023 Scores from 1-5 Higher scores indicate inferior outcome |
| Marginal staining | Baseline, 3 months, 6 months, 12 months | Assessed using Revised FDI criteria 2023 Scores from 1-5 Higher scores indicate inferior outcome |
| Fracture of material and retention | Baseline, 3 months, 6 months, 12 months | Assessed using Revised FDI criteria 2023 Scores from 1-5 Higher scores indicate inferior outcome |
| Colour match | Baseline, 3 months, 6 months, 12 months | Assessed using Revised FDI criteria 2023 Scores from 1-5 Higher scores indicate inferior outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Photographic/Digital Colour match | 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. |
| Photographic/ Digital Colour stability | 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. |
Countries
India
Contacts
PRINCIPAL_INVESTIGATORRuhi Sanvordekar, MDS
Goa Dental College and Hospital
Outcome results
None listed