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

NCT07716033 | Completed

• 1 other identifier: GDCH/IEC/II-2024(18)
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Early Childhood Caries (ECC)

Keywords

Omnichroma; Universal one-shade composite; Colour match; Colour stability; Aesthetic; Functional

Outcome Measures

Primary Outcomes (5)

• Surface Luster and Surface texture

  Assessed using Revised FDI criteria 2023 Scores from 1-5 Higher scores indicate inferior outcome

  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

  Baseline, 3 months, 6 months, 12 months

• Marginal staining

  Assessed using Revised FDI criteria 2023 Scores from 1-5 Higher scores indicate inferior outcome

  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

  Baseline, 3 months, 6 months, 12 months

• Colour match

  Assessed using Revised FDI criteria 2023 Scores from 1-5 Higher scores indicate inferior outcome

  Baseline, 3 months, 6 months, 12 months

Secondary Outcomes (2)

• Photographic/Digital Colour match

  Baseline, 3 months, 6 months, 12 months

• Photographic/ Digital Colour stability

  Baseline, 3 months, 6 months, 12 months

Study Arms (2)

Universal One-shade composite group

EXPERIMENTAL

Other: Tokuyama Palfique Omnichroma composite restoration

Conventional Multi-shade composite

ACTIVE COMPARATOR

Other: 3M Filtek Z350 composite restoration

Interventions

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.

Conventional Multi-shade composite

Tokuyama Palfique Omnichroma composite restoration OTHER

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

Universal One-shade composite group

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Goa Dental College: lead

Study Sites (1)

Goa Dental College and Hospital

Bambolim, Goa, 403202, India

Location

Related Publications (7)

• Bulut S, Sakci Z, Naderi S. Illumination of The Relationship between Ureter and Intervertebral Disc by Computed Tomography. Turk Neurosurg. 2021;31(3):466-471. doi: 10.5137/1019-5149.JTN.32650-20.4.

  PMID: 33624284 BACKGROUND

• Araujo RLS, Correa JR, Galera PD. Ultrastructural morphology of goblet cells of the conjunctiva of dogs. Vet Ophthalmol. 2019 Nov;22(6):891-897. doi: 10.1111/vop.12667. Epub 2019 Apr 1.

  PMID: 30938063 BACKGROUND

• Khanfar M, Al-Remawi M, Al-Akayleh F, Hmouze S. Preparation and Evaluation of Co-amorphous Formulations of Telmisartan-Amino Acids as a Potential Method for Solubility and Dissolution Enhancement. AAPS PharmSciTech. 2021 Mar 21;22(3):112. doi: 10.1208/s12249-021-01952-9.

  PMID: 33748914 BACKGROUND

• Bauer A, Hegen H, Reindl M. Body fluid markers for multiple sclerosis and differential diagnosis from atypical demyelinating disorders. Expert Rev Mol Diagn. 2024 Apr;24(4):283-297. doi: 10.1080/14737159.2024.2334849. Epub 2024 Mar 27.

  PMID: 38533708 BACKGROUND

• Hoeijmakers A, Licitra G, Meijer K, Lam KH, Molenaar P, Strijbis E, Killestein J. Disease severity classification using passively collected smartphone-based keystroke dynamics within multiple sclerosis. Sci Rep. 2023 Feb 1;13(1):1871. doi: 10.1038/s41598-023-28990-6.

  PMID: 36725975 BACKGROUND

• de Abreu JLB, Sampaio CS, Benalcazar Jalkh EB, Hirata R. Analysis of the color matching of universal resin composites in anterior restorations. J Esthet Restor Dent. 2021 Mar;33(2):269-276. doi: 10.1111/jerd.12659. Epub 2020 Sep 29.

  PMID: 32989879 BACKGROUND

• Zulekha, Vinay C, Uloopi KS, RojaRamya KS, Penmatsa C, Ramesh MV. Clinical performance of one shade universal composite resin and nanohybrid composite resin as full coronal esthetic restorations in primary maxillary incisors: A randomized controlled trial. J Indian Soc Pedod Prev Dent. 2022 Apr-Jun;40(2):159-164. doi: 10.4103/jisppd.jisppd_151_22.

  PMID: 35859408 BACKGROUND

Related Links

• Related Info

Study Officials

• Ruhi Sanvordekar, MDS

  Goa Dental College and Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post Graduate student, Department of Pediatric and Preventive Dentistry

Model Details: Split-mouth Randomised controlled trial

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: July 21, 2026
• Study Start: March 1, 2025
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)