Clinical Efficacy of Ceramic vs Resin Block Endocrown

NCT ID: NCT04033380

Last Updated: 2019-07-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-02
• Study Completion Date: 2021-10-31

Brief Summary

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.

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.

Conditions

Tooth Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Resin bloc endocrown

composite-based blocs (Grandio Blocs, VOCO)

Group Type: ACTIVE_COMPARATOR

Resin blocs (Grandio Blocs, VOCO)

Intervention Type: DEVICE

composite-base bloc (Grandio Blocs, VOCO)

Ceramic endocrown

glass ceramic zirconia enhanced lithium silicate glass ceramics (Suprinity, VITA)

Group Type: ACTIVE_COMPARATOR

Ceramic (Suprinity, VITA)

Intervention Type: DEVICE

glass ceramic zirconia enhanced lithium silicate glass ceramics (Suprinity, VITA)

Interventions

Resin blocs (Grandio Blocs, VOCO)

composite-base bloc (Grandio Blocs, VOCO)

Intervention Type: DEVICE

Ceramic (Suprinity, VITA)

glass ceramic zirconia enhanced lithium silicate glass ceramics (Suprinity, VITA)

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wenjuan Yan, PHD

Role: STUDY_CHAIR

Nanfang Hospital, Southern Medical University

Locations

NanFang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wenjuan Yan, PHD

Role: CONTACT

645613053@qq.com

15802018770

Buling Wu, PHD

Role: CONTACT

02062787149

Facility Contacts

WenJuan Yan, PHD

Role: primary

645613053@qq.com

15802018770

References

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.

Reference Type: BACKGROUND

PMID: 20847997 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29055692 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32571397 (View on PubMed)

Other Identifiers

NanFangH

Identifier Type: -

Identifier Source: org_study_id