Endocrown and 90° Shoulder Endocrown

NCT ID: NCT03398395

Last Updated: 2022-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2023-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Endocrown Restoration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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endocrown restoration

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.

Group Type ACTIVE_COMPARATOR

endocrown restoration

Intervention Type PROCEDURE

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.

90° shoulder endocrown restoration

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.

Group Type ACTIVE_COMPARATOR

90° shoulder endocrown restoration

Intervention Type PROCEDURE

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.

Interventions

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endocrown restoration

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.

Intervention Type PROCEDURE

90° shoulder endocrown restoration

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. 18-60 year old patients with healthy body, the tooth is molar, root tip no obvious damage, no root fracture by X-ray;
2. after complete root canal therapy, the remaining 4 wall intact tooth tissue;
3. after complete root canal therapy, the remaining 3 wall intact tooth tissue;
4. have good oral hygiene habits;
5. agreed to participate in the trial and signed the informed consent form;
6. patients who are not participating in other clinical trials;
7. after completion of the repair, compliance with the USPHS evaluation criteria of marginal density class A cases

Exclusion Criteria

1. obvious destruction of the apical tissue and large cysts;
2. severe periodontitis patients;
3. oral malignant tumor patients;
4. radiotherapy patients;
5. pregnant women;
6. patients with mental illness or systemic diseases;
7. people who can not take care of themselves;
8. the researchers believe that is not suitable for the test.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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BuLing Wu, PHD

Role: STUDY_DIRECTOR

Nanfang Hospital, Southern Medical University

Locations

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NanFang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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WenJuan Yan, PHD

Role: CONTACT

15802018770

Facility Contacts

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WenJuan Yan, PHD

Role: primary

15802018770

References

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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.

Reference Type DERIVED
PMID: 31340845 (View on PubMed)

Other Identifiers

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NFEC-2017-141

Identifier Type: -

Identifier Source: org_study_id

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