NCT06543654

Brief Summary

The aim of this study was to conduct a clinical trial utilizing a modified split-mouth, double-blinded, randomized strategy to clinically assess template assisted one shade structural colored versus universal multi-shade direct composite veneers

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
4 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 9, 2024

Completed
Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

1.6 years

First QC Date

August 4, 2024

Last Update Submit

August 7, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Clinical evaluation was performed at baseline, six, nine, twelve, and eighteen months by two calibrated examiners using modified United States Public Health Service (USPHS) criteria

    The perfect clinical scenario was represented by a score of 0, clinically acceptable by a score of 1, dubious by a score of 2, and clinically unsatisfactory by a score of 3 and 4.

    eighteen months

Study Arms (2)

Omnichroma

EXPERIMENTAL

Monochromatic structural colored composite

Other: OmnichromaOther: Ceram. X Spectra

Ceram. X Spectra

EXPERIMENTAL

Universal multi shade composite

Other: OmnichromaOther: Ceram. X Spectra

Interventions

Each participants had two kinds of veneers

Ceram. X SpectraOmnichroma

Ceram. X Spectra

Ceram. X SpectraOmnichroma

Eligibility Criteria

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

You may qualify if:

  • better dental hygiene
  • discolored vital anterior teeth

You may not qualify if:

  • Para functional activities
  • Non-vital teeth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry

Tanta, Egypt

Location

Related Publications (6)

  • Kobayashi S, Nakajima M, Furusawa K, Tichy A, Hosaka K, Tagami J. Color adjustment potential of single-shade resin composite to various-shade human teeth: Effect of structural color phenomenon. Dent Mater J. 2021 Jul 31;40(4):1033-1040. doi: 10.4012/dmj.2020-364. Epub 2021 Apr 20.

  • Arai Y, Kurokawa H, Takamizawa T, Tsujimoto A, Saegusa M, Yokoyama M, Miyazaki M. Evaluation of structural coloration of experimental flowable resin composites. J Esthet Restor Dent. 2021 Mar;33(2):284-293. doi: 10.1111/jerd.12674. Epub 2020 Oct 24.

  • Furusawa K, Kobayashi S, Yamashita A, Tichy A, Hosaka K, Shimada Y, Nakajima M. Effect of filler load on structural coloration and color adjustment potential of resin composites. Dent Mater J. 2023 May 30;42(3):343-350. doi: 10.4012/dmj.2022-199. Epub 2023 Jan 28.

  • 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.

  • Castro FLA, Durand LB. Influence of cavity wall thickness on the color adjustment potential of single-shade resin composites. J Am Dent Assoc. 2024 Jul;155(7):605-613. doi: 10.1016/j.adaj.2024.03.006. Epub 2024 May 31.

  • 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.

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, OUTCOMES ASSESSOR
Masking Details
This clinical trial was double-blind since the evaluators who were not included in the restorative procedures and the participants were blinded to tested groups, but the operator wasn't blinded to these groups
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized controlled clinical study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

August 4, 2024

First Posted

August 9, 2024

Study Start

July 19, 2022

Primary Completion

February 5, 2024

Study Completion

April 9, 2024

Last Updated

August 9, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations