Clinical Efficacy of Ceramic vs Resin Block Endocrown

Clinical Efficacy of Ceramic vs Resin Bloc Endocrowns: Study Protocol for the Randomized Clinical Trial

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.

Study Overview

• Status: Unknown
• Conditions: Tooth Diseases
• Intervention / Treatment: Device: Resin blocs (Grandio Blocs, VOCO); Device: Ceramic (Suprinity, VITA)

Detailed Description

Pulpal and periapical diseases are the main causes of tooth loss. Root canal treatment (RCT) is the only effective way to treat these diseases. However, failure of RCT is commonly seen without coronal restoration.Endocrown is a new type of onlay with a retainer in the pulp cavity which consists of a cervical margin in the form of a butt joint and a preparation of the pulp chamber.This restoration method is not only good at the preservation of residual tooth tissue, but also suitable for severely damaged molars or premolars after dental pulp treatment.More and more endondontist tend to use this ways because they are a minimally invasive solution in such cases.Endocrown is mainly made of glass-ceramics, which has the advantages of beautiful appearance, high hardness and good biocompatibility. However, ceramic materials are brittle and fracturable, and need to be sintered twice in the manufacturing process, which is relatively complex and time-consuming. Composite resin block material is a new type of composite material developed in recent years. It is used for chairside CAD/CAM restoration,It has beautiful and natural color, and its elastic modulus is close to dentin. Therefore, it is more compatible with natural teeth in performance.Moreover, In the process of making, the steps of secondary sintering and glazing are omitted and shortened. But, there was no sufficient data to verify which material was more effective. The main aim of this trial is to compare the clinical efficacy of ceramic vs resin-based bloc endocrown. Other objectives include looking for the prognostic and influence factors of the related effects.

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

Contacts and Locations

• Study Contact: Name: Buling Wu, PHD; Phone Number: 02062787149

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 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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.
2. The patient has three or four walls of intact tooth tissue after root canal treatment
3. The patient has good oral hygiene.
4. The patient has signed an informed consent form.
5. The patient is not participating in any other clinical trial.
6. The patient has received a class A assessment according to FDI criteria for marginal adaptation after restoration.

Exclusion Criteria:

1. Obvious destruction of the apical tissue or presence of large cysts or both
2. Severe periodontitis
3. Oral malignant tumor(s)
4. Undergoing radiotherapy
5. Pregnancy
6. Mental illness or systemic diseases
7. Incapable of self-care
8. Unsuitable for the trial as deemed by the researchers

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Resin bloc endocrown; composite-based blocs (Grandio Blocs, VOCO)	Device: Resin blocs (Grandio Blocs, VOCO); composite-base bloc (Grandio Blocs, VOCO)
ACTIVE_COMPARATOR: Ceramic endocrown; glass ceramic zirconia enhanced lithium silicate glass ceramics (Suprinity, VITA)	Device: Ceramic (Suprinity, VITA); glass ceramic zirconia enhanced lithium silicate glass ceramics (Suprinity, VITA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fracture of material and retention：	Clinical evaluations were performed at baseline and 24 months according to FDI criteria by 2 independent evaluators. A: Intact; B: Crack apparent on transillumination; C: Fracture observable; D: Endocrown lost (state at which interface debond occurred).	2 years
wear	Clinical evaluations were performed at baseline and 24 months according to FDI criteria by 2 independent evaluators.	2 years
Recurrence of caries	Clinical evaluations were performed at baseline and 24 months according to FDI criteria by 2 independent evaluators.	2 years

Collaborators and Investigators

• Sponsor: Nanfang Hospital of Southern Medical University
• Investigators: Study Chair: Wenjuan Yan, PHD, Nanfang Hospital of Southern Medical University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 2, 2019
• Primary Completion (ANTICIPATED): May 30, 2021
• Study Completion (ANTICIPATED): October 31, 2021

Study Registration Dates

• First Submitted: July 24, 2019
• First Submitted That Met QC Criteria: July 24, 2019
• First Posted (ACTUAL): July 26, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 26, 2019
• Last Update Submitted That Met QC Criteria: July 24, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Ceramic, Resin Bloc, Endocrown , Root Canal Treatment, Molar
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases
• Other Study ID Numbers: NanFangH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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