Aesthetic and Functional Evaluation of a Universal One-Shade Composite in Primary Maxillary Incisors
15. juli 2026 oppdatert av: Ruhi Sanvordekar, Goa Dental College
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
- 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
30
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Goa
-
Bambolim, Goa, India, 403202
- Goa Dental College and Hospital
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Ja
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Universal One-shade composite group
|
Tokuyama Palfique Omnichroma is a universal one-shade resin composite used for direct restoration of primary maxillary incisors.
|
|
Aktiv komparator: Conventional Multi-shade composite
|
3M Filtek Z350 XT is a nanofilled resin composite used as the active comparator for direct restoration of primary maxillary incisors.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Surface Luster and Surface texture
Tidsramme: Baseline, 3 months, 6 months, and 12 months
|
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
Tidsramme: Baseline, 3 months, 6 months, 12 months
|
Assessed using Revised FDI criteria 2023 Scores from 1-5 Higher scores indicate inferior outcome
|
Baseline, 3 months, 6 months, 12 months
|
|
Marginal staining
Tidsramme: Baseline, 3 months, 6 months, 12 months
|
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
Tidsramme: Baseline, 3 months, 6 months, 12 months
|
Assessed using Revised FDI criteria 2023 Scores from 1-5 Higher scores indicate inferior outcome
|
Baseline, 3 months, 6 months, 12 months
|
|
Colour match
Tidsramme: Baseline, 3 months, 6 months, 12 months
|
Assessed using Revised FDI criteria 2023 Scores from 1-5 Higher scores indicate inferior outcome
|
Baseline, 3 months, 6 months, 12 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Photographic/Digital Colour match
Tidsramme: 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.
|
Baseline, 3 months, 6 months, 12 months
|
|
Photographic/ Digital Colour stability
Tidsramme: 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.
|
Baseline, 3 months, 6 months, 12 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Ruhi Sanvordekar, MDS, Goa Dental College and Hospital
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. mars 2025
Primær fullføring (Faktiske)
28. februar 2026
Studiet fullført (Faktiske)
28. februar 2026
Datoer for studieregistrering
Først innsendt
9. juli 2026
Først innsendt som oppfylte QC-kriteriene
15. juli 2026
Først lagt ut (Faktiske)
21. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
21. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
15. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- GDCH/IEC/II-2024(18)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
Only summary study results will be made publicly available.
Individual participant data and participant identifiers will not be shared to maintain confidentiality.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .