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Endocrown and 90° Shoulder Endocrown

Comparison of Long Term Clinical Efficacy of Different Computer-Aided Design & Computer-Aided Manufacturing(CAD/CAM) Materials for the Restoration of Teeth With Root Canal Therapy With Endocrown or 90° Shoulder Endocrown

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03398395
Enrollment
200
Registered
2018-01-12
Start date
2017-03-01
Completion date
2023-06-30
Last updated
2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endocrown Restoration

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.

Interventions

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.

PROCEDURE90° 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.

Sponsors

Nanfang Hospital, Southern Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
USPHS criteria for dental restorations assessment2 YearsThis 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.

Secondary

MeasureTime frameDescription
Marginal Adaptation2 YearsClinical reevaluations were so far performed at baseline and 24 months after insertion according to modified United States Public Health Service (USPHS) criteria by 2 independent evaluators. A: Crown margin not discernible; probe does not catch; B: Probe catches on crown margin but no gap; gap or chipping on probing, with enamel exposed but polishable; C: Gap or chipping, with dentin or liner exposed ; D: Partial fracture, fracture, luxation.
Marginal discoloration2 YearsClinical reevaluations were so far performed at baseline and 24 months after insertion according to modified United States Public Health Service (USPHS) criteria by 2 independent evaluators. A: No discoloration on the margin between the restoration and the tooth structure; B: Superficial discoloration on the margin between the restoration and the tooth structure; does not penetrate in pulpal direction; C: Discoloration has penetrated along the margin of the restorative material in pulpal direction.
Integrity of restoration2 YearsClinical reevaluations were so far performed at baseline and 24 months after insertion according to modified United States Public Health Service (USPHS) criteria by 2 independent evaluators. A: Intact; B: Crack apparent on transillumination; C: Fracture observable; D: Crown lost(state at which interface debond occurred).

Countries

China

Contacts

Primary ContactWenJuan Yan, PHD
645613053@qq.com15802018770

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026