NCT03398395

Brief Summary

Use chairside Computer-Aided Design \& Computer-Aided Manufacturing(CAD/CAM) system (computer aided design / manufacture), using glass ceramic zirconia enhanced lithium silicate glass ceramics (VITA, SUPRINITY, VS) material, compare the difference of firmness, comfort and durability between two kinds of root canal restoration methods:endocrown and 90° shoulder endocrown. Objective to establish the optimal method and material for the restoration of the teeth with root canal therapy.

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 Mar 2017

Longer than P75 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

March 1, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 12, 2018

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

April 19, 2022

Status Verified

April 1, 2022

Enrollment Period

6 years

First QC Date

December 28, 2017

Last Update Submit

April 18, 2022

Conditions

Endocrown Restoration

Outcome Measures

Primary Outcomes (1)

  • USPHS criteria for dental restorations assessment

    This criteria is composed of three dimensions (biological, functional and esthetic), each consisting of several items that are assessed by clinical and radiographic examination. Some items are evaluated quantitatively, others visually.The score of all items is retained as the overall score of the restoration.

    2 Years

Secondary Outcomes (3)

  • Marginal Adaptation

    2 Years

  • Marginal discoloration

    2 Years

  • Integrity of restoration

    2 Years

Study Arms (2)

endocrown restoration

ACTIVE COMPARATOR

a cervical margin in the form of a butt joint and a preparation of the pulp chamber that does not extend into the root canals.

Procedure: endocrown restoration

90° shoulder endocrown restoration

ACTIVE COMPARATOR

a 90°cervical margin in the form of a butt joint and a preparation of the pulp chamber that does not extend into the root canals.

Procedure: 90° shoulder endocrown restoration

Interventions

endocrown restorationPROCEDURE

a cervical margin in the form of a butt joint and a preparation of the pulp chamber that does not extend into the root canals.

endocrown restoration
90° shoulder endocrown restorationPROCEDURE

a 90°cervical margin in the form of a butt joint and a preparation of the pulp chamber that does not extend into the root canals.

90° shoulder endocrown restoration

Eligibility Criteria

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

You may qualify if:

  • year old patients with healthy body, the tooth is molar, root tip no obvious damage, no root fracture by X-ray;
  • after complete root canal therapy, the remaining 4 wall intact tooth tissue;
  • after complete root canal therapy, the remaining 3 wall intact tooth tissue;
  • have good oral hygiene habits;
  • agreed to participate in the trial and signed the informed consent form;
  • patients who are not participating in other clinical trials;
  • after completion of the repair, compliance with the USPHS evaluation criteria of marginal density class A cases

You may not qualify if:

  • obvious destruction of the apical tissue and large cysts;
  • severe periodontitis patients;
  • oral malignant tumor patients;
  • radiotherapy patients;
  • pregnant women;
  • patients with mental illness or systemic diseases;
  • people who can not take care of themselves;
  • the researchers believe that is not suitable for the test.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NanFang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

Related Publications (1)

  • Sun J, Ruan W, He J, Lin X, Ci B, Yin S, Yan W. Clinical efficacy of different marginal forms of endocrowns: study protocol for a randomized controlled trial. Trials. 2019 Jul 24;20(1):454. doi: 10.1186/s13063-019-3530-1.

    PMID: 31340845DERIVED

Study Officials

  • BuLing Wu, PHD

    Nanfang Hospital, Southern Medical University

    STUDY DIRECTOR

Central Study Contacts

WenJuan Yan, PHD

CONTACT

15802018770645613053@qq.com

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

December 28, 2017

First Posted

January 12, 2018

Study Start

March 1, 2017

Primary Completion

March 1, 2023

Study Completion

June 1, 2023

Last Updated

April 19, 2022

Record last verified: 2022-04

Locations

CN(1)