NCT05346744

Brief Summary

The aim of this clinic self-control study was to evaluate the trueness of occlusal contact affected by six ceramic materials during chairside fabricating process and offer recommendations for occlusal offset according to different ceramic materials in CEREC CAD/CAM design process.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2019

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 26, 2022

Completed
Last Updated

April 26, 2022

Status Verified

April 1, 2022

Enrollment Period

1.7 years

First QC Date

April 15, 2022

Last Update Submit

April 21, 2022

Conditions

Tooth Defect

Keywords

chairside CAD/CAMceramic materialstruenessocclusal contact

Outcome Measures

Primary Outcomes (3)

  • milling trueness(μm)

    the absolute 3D deviation of occlusal contact points before and after milling

    1 week

  • postprocessing trueness(μm)

    the absolute 3D deviation of occlusal contact points before and after postprocessing

    1 week

  • clinical trueness(μm)

    the absolute 3D deviation of occlusal contact points before and after occlusal adjustment

    1 week

Study Arms (6)

Zirconia

EXPERIMENTAL

10 crowns made of zirconia from 10 individual were milled, post-processed and occlusal adjusted in patients' mouth.

Other: Chairside CAD/CAM ceramic materials for dental restoration

Celtra Duo

EXPERIMENTAL

10 crowns made of Celtra Duo from 10 individual were milled, post-processed and occlusal adjusted in patients' mouth.

Other: Chairside CAD/CAM ceramic materials for dental restoration

e.max CAD

EXPERIMENTAL

10 crowns made of e.max CAD from 10 individual were milled, post-processed and occlusal adjusted in patients' mouth.

Other: Chairside CAD/CAM ceramic materials for dental restoration

Lici UPCERA

EXPERIMENTAL

10 crowns made of Lici from 10 individual were milled, post-processed and occlusal adjusted in patients' mouth.

Other: Chairside CAD/CAM ceramic materials for dental restoration

Enamic

EXPERIMENTAL

10 crowns made of Enamic from 10 individual were milled, post-processed and occlusal adjusted in patients' mouth.

Other: Chairside CAD/CAM ceramic materials for dental restoration

Runci UPCERA

EXPERIMENTAL

10 crowns made of Runci from 10 individual were milled, post-processed and occlusal adjusted in patients' mouth.

Other: Chairside CAD/CAM ceramic materials for dental restoration

Interventions

Chairside CAD/CAM ceramic materials for dental restorationOTHER

6 crowns made from 6 chairside ceramic materials were milled by CEREC MCXL-EF mode for mandibular first molar of each participant. The six materials are as follows: ZIR: InCoris TZI (Dentsply Sirona, York, PA)， CD: Celtra Duo (Dentsply Sirona, York, PA), EMA: e.max CAD (ivoclar, Vivadent AG), LC: LiCi (UPCERA, China), ENA: Vita Enamic (Vita Zahnfabrik, Bad Sackingen, Germany) RC: RunCi (UPCERA, China)

Celtra DuoEnamicLici UPCERARunci UPCERAZirconiae.max CAD

Eligibility Criteria

Age20 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • with one mandibular first molar requiring crown restoration that have undergone root canal treatment;
  • with complete permanent dentition;

You may not qualify if:

  • with carious lesions, abrasions, attrition, erosions or any kind of tooth defects;
  • with any kind of restorations in occlusal surfaces;
  • with any sign of temporomandibular dysfunction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fujian Medical University

Fuzhou, Fujian, 350004, China

Location

Study Officials

  • Hao Yu

    Fujian Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Care providers and outcomes assessors wouldn't know the materials of the specimen.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Ten individuals with tooth defect of mandibular first molar were selected to participate in the study. 6 crowns made from 6 chairside materials were milled by CEREC MCXL-EF mode for each mandibular first molar.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
vice dean of school and hospital of stomatology

Study Record Dates

First Submitted

April 15, 2022

First Posted

April 26, 2022

Study Start

November 1, 2019

Primary Completion

July 1, 2021

Study Completion

August 1, 2021

Last Updated

April 26, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)