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Completed
NCT07716033
Aesthetic and Functional Evaluation of a Universal One-Shade Composite in Primary Maxillary Incisors
Conditions: Early Childhood Caries (ECC)
Sex: All
Ages: 3 Years – 5 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 30
Sponsor: Goa Dental College
Location: Goa Dental College and Hospital Bambolim Goa
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07716033). StuddyBuddy aggregates publicly available trial information.