NCT05501808

Brief Summary

This is in vivo study aimed to evaluate the color stability of the newly introduced resin ceramic matrix (cerasmart )\& (vita-enamic ) after a one year

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

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

June 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

August 12, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 15, 2022

Completed
Last Updated

March 13, 2025

Status Verified

August 1, 2022

Enrollment Period

1 year

First QC Date

August 12, 2022

Last Update Submit

March 11, 2025

Conditions

Keywords

ceramicscolorstabilityresin Matrix

Outcome Measures

Primary Outcomes (1)

  • color change

    measurement of restoration using digital spectrophotometer

    12 months

Secondary Outcomes (1)

  • patient satisfaction

    12 months

Study Arms (2)

Enamic group

EXPERIMENTAL

patient in this group received a restoration with enamic material

Procedure: enamic

Cerasmart group

ACTIVE COMPARATOR

patient in this group received a restoration with Cerasmart material

Procedure: cerasmart

Interventions

cerasmartPROCEDURE

the patient received a crown made of cerasmart ceramic

Cerasmart group
enamicPROCEDURE

the patient received a crown made of enamic ceramic

Enamic group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • diagnose need for restoration in endo treated posterior teeth
  • good general health and oral health
  • occlusal stability

You may not qualify if:

  • smoking
  • pregnancy
  • use drugs that affect oral health
  • Para functional habits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry- Fayoum University

Al Fayyum, Faiyum Governorate, 63514, Egypt

Location

Related Publications (3)

  • Kanat-Erturk B. Color Stability of CAD/CAM Ceramics Prepared with Different Surface Finishing Procedures. J Prosthodont. 2020 Feb;29(2):166-172. doi: 10.1111/jopr.13019. Epub 2019 Jan 24.

    PMID: 30638286BACKGROUND
  • Jorquera GJ, Atria PJ, Galan M, Feureisen J, Imbarak M, Kernitsky J, Cacciuttolo F, Hirata R, Sampaio CS. A comparison of ceramic crown color difference between different shade selection methods: Visual, digital camera, and smartphone. J Prosthet Dent. 2022 Oct;128(4):784-792. doi: 10.1016/j.prosdent.2020.07.029. Epub 2021 Mar 17.

    PMID: 33741142BACKGROUND
  • 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.

MeSH Terms

Interventions

ENAMIC

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: patient with endo treated first molar
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor in oral & maxillofacial Surgery Department

Study Record Dates

First Submitted

August 12, 2022

First Posted

August 15, 2022

Study Start

June 1, 2021

Primary Completion

June 1, 2022

Study Completion

August 1, 2022

Last Updated

March 13, 2025

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations