Clinical Efficacy of Ceramic vs Resin Block Endocrown
Primary Purpose
Tooth Diseases
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Resin blocs (Grandio Blocs, VOCO)
Ceramic (Suprinity, VITA)
Sponsored by
About this trial
This is an interventional treatment trial for Tooth Diseases focused on measuring Ceramic, Resin Bloc, Endocrown , Root Canal Treatment, Molar
Eligibility Criteria
Inclusion Criteria:
- 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.
- The patient has three or four walls of intact tooth tissue after root canal treatment
- The patient has good oral hygiene.
- The patient has signed an informed consent form.
- The patient is not participating in any other clinical trial.
- The patient has received a class A assessment according to FDI criteria for marginal adaptation after restoration.
Exclusion Criteria:
- Obvious destruction of the apical tissue or presence of large cysts or both
- Severe periodontitis
- Oral malignant tumor(s)
- Undergoing radiotherapy
- Pregnancy
- Mental illness or systemic diseases
- Incapable of self-care
- Unsuitable for the trial as deemed by the researchers
Sites / Locations
- NanFang Hospital, Southern Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Resin bloc endocrown
Ceramic endocrown
Arm Description
composite-based blocs (Grandio Blocs, VOCO)
glass ceramic zirconia enhanced lithium silicate glass ceramics (Suprinity, VITA)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
wear
Clinical evaluations were performed at baseline and 24 months according to FDI criteria by 2 independent evaluators.
Recurrence of caries
Clinical evaluations were performed at baseline and 24 months according to FDI criteria by 2 independent evaluators.
Full Information
NCT ID
NCT04033380
First Posted
July 24, 2019
Last Updated
July 24, 2019
Sponsor
Nanfang Hospital, Southern Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04033380
Brief Title
Clinical Efficacy of Ceramic vs Resin Block Endocrown
Official Title
Clinical Efficacy of Ceramic vs Resin Bloc Endocrowns: Study Protocol for the Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 2, 2019 (Actual)
Primary Completion Date
May 30, 2021 (Anticipated)
Study Completion Date
October 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanfang Hospital, Southern Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Diseases
Keywords
Ceramic, Resin Bloc, Endocrown , Root Canal Treatment, Molar
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Resin bloc endocrown
Arm Type
Active Comparator
Arm Description
composite-based blocs (Grandio Blocs, VOCO)
Arm Title
Ceramic endocrown
Arm Type
Active Comparator
Arm Description
glass ceramic zirconia enhanced lithium silicate glass ceramics (Suprinity, VITA)
Intervention Type
Device
Intervention Name(s)
Resin blocs (Grandio Blocs, VOCO)
Intervention Description
composite-base bloc (Grandio Blocs, VOCO)
Intervention Type
Device
Intervention Name(s)
Ceramic (Suprinity, VITA)
Intervention Description
glass ceramic zirconia enhanced lithium silicate glass ceramics (Suprinity, VITA)
Primary Outcome Measure Information:
Title
Marginal Adaptation
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Fracture of material and retention:
Description
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).
Time Frame
2 years
Title
wear
Description
Clinical evaluations were performed at baseline and 24 months according to FDI criteria by 2 independent evaluators.
Time Frame
2 years
Title
Recurrence of caries
Description
Clinical evaluations were performed at baseline and 24 months according to FDI criteria by 2 independent evaluators.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
The patient has three or four walls of intact tooth tissue after root canal treatment
The patient has good oral hygiene.
The patient has signed an informed consent form.
The patient is not participating in any other clinical trial.
The patient has received a class A assessment according to FDI criteria for marginal adaptation after restoration.
Exclusion Criteria:
Obvious destruction of the apical tissue or presence of large cysts or both
Severe periodontitis
Oral malignant tumor(s)
Undergoing radiotherapy
Pregnancy
Mental illness or systemic diseases
Incapable of self-care
Unsuitable for the trial as deemed by the researchers
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wenjuan Yan, PHD
Phone
15802018770
Email
645613053@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Buling Wu, PHD
Phone
02062787149
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wenjuan Yan, PHD
Organizational Affiliation
Nanfang Hospital, Southern Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
NanFang Hospital, Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
WenJuan Yan, PHD
Phone
15802018770
Email
645613053@qq.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20847997
Citation
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.
Results Reference
background
PubMed Identifier
29055692
Citation
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.
Results Reference
background
PubMed Identifier
32571397
Citation
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.
Results Reference
derived
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Clinical Efficacy of Ceramic vs Resin Block Endocrown
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