NCT04033380

Brief Summary

Compare the comfort and durability of Ceramic (VITA,Suprinity ,VS) vs Resin Bloc (VOCO, Grandio Bloc,GB) Endocrown by chairside CAD/CAM system (computer aided design / manufacture). Objective:To provide information of material selection for the chair-side restoration of the teeth after root canal treatment.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

May 2, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 26, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
Last Updated

July 26, 2019

Status Verified

July 1, 2019

Enrollment Period

2.1 years

First QC Date

July 24, 2019

Last Update Submit

July 24, 2019

Conditions

Tooth Diseases

Keywords

Ceramic, Resin Bloc, Endocrown , Root Canal Treatment, Molar

Outcome Measures

Primary Outcomes (1)

  • Marginal Adaptation

    FDI criteria for dental restorations assessment（2010） This criteria is composed of three dimensions (biological, functional and esthetic), each consisting of several items that are assessed by clinical and radiographic examination according to Likert scales of 5 terms. Some items are evaluated quantitatively, others visually.The worst score of all items is retained as The overall score of the restoration, thus resulting in a single (ordinal) primary outcome.

    2 years

Secondary Outcomes (3)

  • Fracture of material and retention：

    2 years

  • wear

    2 years

  • Recurrence of caries

    2 years

Study Arms (2)

Resin bloc endocrown

ACTIVE COMPARATOR

composite-based blocs (Grandio Blocs, VOCO)

Device: Resin blocs (Grandio Blocs, VOCO)

Ceramic endocrown

ACTIVE COMPARATOR

glass ceramic zirconia enhanced lithium silicate glass ceramics (Suprinity, VITA)

Device: Ceramic (Suprinity, VITA)

Interventions

Resin blocs (Grandio Blocs, VOCO)DEVICE

composite-base bloc (Grandio Blocs, VOCO)

Resin bloc endocrown
Ceramic (Suprinity, VITA)DEVICE

glass ceramic zirconia enhanced lithium silicate glass ceramics (Suprinity, VITA)

Ceramic endocrown

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient is healthy and is 18-75 years old and has molar teeth and tooth root apex without evident damage and no root fracture, as determined by x-ray.
  • The patient has three or four walls of intact tooth tissue after root canal treatment
  • The patient has good oral hygiene.
  • The patient has signed an informed consent form.
  • The patient is not participating in any other clinical trial.
  • The patient has received a class A assessment according to FDI criteria for marginal adaptation after restoration.

You may not qualify if:

  • Obvious destruction of the apical tissue or presence of large cysts or both
  • Severe periodontitis
  • Oral malignant tumor(s)
  • Undergoing radiotherapy
  • Pregnancy
  • Mental illness or systemic diseases
  • Incapable of self-care
  • Unsuitable for the trial as deemed by the researchers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NanFang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

Related Publications (3)

  • Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation - clinical criteria for the evaluation of direct and indirect restorations. Update and clinical examples. J Adhes Dent. 2010 Aug;12(4):259-72. doi: 10.3290/j.jad.a19262.

    PMID: 20847997BACKGROUND

  • Marquillier T, Domejean S, Le Clerc J, Chemla F, Gritsch K, Maurin JC, Millet P, Perard M, Grosgogeat B, Dursun E. The use of FDI criteria in clinical trials on direct dental restorations: A scoping review. J Dent. 2018 Jan;68:1-9. doi: 10.1016/j.jdent.2017.10.007. Epub 2017 Oct 18.

    PMID: 29055692BACKGROUND

  • Wang J, Ling Z, Zheng Z, Zheng C, Gai Y, Zeng Y, Zhu X, Chen L, Wu B, Yan W. Clinical efficacy of ceramic versus resin-based composite endocrowns in Chinese adults: study protocol for a randomized controlled trial. Trials. 2020 Jun 22;21(1):559. doi: 10.1186/s13063-020-04506-9.

    PMID: 32571397DERIVED

MeSH Terms

Conditions

Tooth Diseases

Condition Hierarchy (Ancestors)

Stomatognathic Diseases

Study Officials

  • Wenjuan Yan, PHD

    Nanfang Hospital, Southern Medical University

    STUDY CHAIR

Central Study Contacts

Wenjuan Yan, PHD

CONTACT

15802018770645613053@qq.com

Buling Wu, PHD

CONTACT

02062787149

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2019

First Posted

July 26, 2019

Study Start

May 2, 2019

Primary Completion

May 30, 2021

Study Completion

October 31, 2021

Last Updated

July 26, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)