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

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.

Study Overview

• Status: Recruiting
• Conditions: Endocrown Restoration
• Intervention / Treatment: Procedure: endocrown restoration; Procedure: 90° shoulder endocrown restoration

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Recruiting
      • Nanfang Hospital, Southern Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: 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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Marginal Adaptation	Clinical 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.	2 Years
Marginal discoloration	Clinical 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.	2 Years
Integrity of restoration	Clinical 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).	2 Years

Collaborators and Investigators

• Sponsor: Nanfang Hospital of Southern Medical University
• Investigators: Study Director: BuLing Wu, PHD, Nanfang Hospital of Southern Medical University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: December 28, 2017
• First Submitted That Met QC Criteria: January 7, 2018
• First Posted (Actual): January 12, 2018

Study Record Updates

• Last Update Posted (Actual): April 19, 2022
• Last Update Submitted That Met QC Criteria: April 18, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: NFEC-2017-141

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No