NCT06510400

Brief Summary

Assess color stability of direct veneers over an 18-month recall periods

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 19, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 19, 2024

Completed
Last Updated

July 24, 2024

Status Verified

July 1, 2024

Enrollment Period

1.6 years

First QC Date

July 14, 2024

Last Update Submit

July 22, 2024

Conditions

Tooth Discoloration

Outcome Measures

Primary Outcomes (1)

  • Color stability evaluation

    Two calibrated evaluators who were not engaged in the insertion of veneer restorations used VITA Easyshade V to measure the color (ΔE). The device was calibrated before reading.

    18 months

Study Arms (2)

OMNICHROMA

EXPERIMENTAL

single shade composite was placed to prepared tooth enamel via U veneer template technique

Other: OMNICHROMAOther: Ceram. x spectra

Ceram. x spectra

EXPERIMENTAL

multi shade composite was placed to prepared tooth enamel via U veneer template technique

Other: OMNICHROMAOther: Ceram. x spectra

Interventions

OMNICHROMAOTHER

supra nano filled composite

Ceram. x spectraOMNICHROMA
Ceram. x spectraOTHER

nano hybrid composite resin

Ceram. x spectraOMNICHROMA

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • have good hygiene.
  • No medical diseases
  • discolored vital anterior teeth

You may not qualify if:

  • para functional activities.
  • non vital teeth.
  • severe intrinsic discoloration.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Restorative Department, Faculty of Dentistry, Tanta University

Tanta, 31527, Egypt

Location

Related Publications (10)

  • Hirata R, Hilgert LA, Sampaio CS, de Andrade OS, Melo G, Ritter AV. Quo vadis, esthetic dentistry? Part II: Composite resin overtreatment and social media appeal. J Esthet Restor Dent. 2024 Jan;36(1):32-36. doi: 10.1111/jerd.13162. Epub 2023 Dec 23.

    PMID: 38142060BACKGROUND

  • 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: 32989879BACKGROUND

  • Fahl N Jr,, Ritter AV. Composite veneers: The direct-indirect technique revisited. J Esthet Restor Dent. 2021 Jan;33(1):7-19. doi: 10.1111/jerd.12696. Epub 2020 Dec 18.

    PMID: 33336852BACKGROUND

  • Kam Hepdeniz O, Temel UB. Clinical survival of No-prep indirect composite laminate veneers: a 7-year prospective case series study. BMC Oral Health. 2023 May 3;23(1):257. doi: 10.1186/s12903-023-02949-5.

    PMID: 37138297BACKGROUND

  • Zhao X, Zanetti F, Wang L, Pan J, Majeed S, Malmstrom H, Peitsch MC, Hoeng J, Ren Y. Effects of different discoloration challenges and whitening treatments on dental hard tissues and composite resin restorations. J Dent. 2019 Oct;89:103182. doi: 10.1016/j.jdent.2019.103182. Epub 2019 Aug 17.

    PMID: 31430508BACKGROUND

  • Miranda AO, Favoreto MW, Matos TP, Castro AS, Kunz P, Souza JL, Carvalho P, Reis A, Loguercio AD. Color Match of a Universal-shade Composite Resin for Restoration of Non-carious Cervical Lesions: An Equivalence Randomized Clinical Trial. Oper Dent. 2024 Jan 1;49(1):20-33. doi: 10.2341/23-021-C.

    PMID: 38057996BACKGROUND

  • Huang M, Wang Y, Sun Y, Zhou Y, Liu Y, Ye H. The accuracies of three intraoral scanners with regard to shade determination: An in vitro study. J Prosthodont. 2023 Jun;32(5):111-117. doi: 10.1111/jopr.13571. Epub 2022 Aug 10.

    PMID: 35848886BACKGROUND

  • Sabatini C. Color Stability Behavior of Methacrylate-based Resin Composites Polymerized with Light-emitting Diodes and Quartz-Tungsten-Halogen. Oper Dent. 2015 May-Jun;40(3):271-81. doi: 10.2341/14-080-L. Epub 2014 Oct 2.

    PMID: 25275958BACKGROUND

  • El-Rashidy AA, Abdelraouf RM, Habib NA. Effect of two artificial aging protocols on color and gloss of single-shade versus multi-shade resin composites. BMC Oral Health. 2022 Aug 1;22(1):321. doi: 10.1186/s12903-022-02351-7.

    PMID: 35915423BACKGROUND

  • Mahrous AI, Salama AA, Shabaan AA, Abdou A, Radwan MM. Color stability of two different resin matrix ceramics: randomized clinical trial. BMC Oral Health. 2023 Sep 14;23(1):665. doi: 10.1186/s12903-023-03364-6.

    PMID: 37710194BACKGROUND

MeSH Terms

Conditions

Tooth Discoloration

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
double blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

July 14, 2024

First Posted

July 19, 2024

Study Start

July 19, 2022

Primary Completion

February 5, 2024

Study Completion

April 9, 2024

Last Updated

July 24, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)