Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 98 of 119 for:    ZIRCONIUM

Clinical Efficacy of Ceramic vs Resin Block Endocrown

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04033380
Recruitment Status : Recruiting
First Posted : July 26, 2019
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
Nanfang Hospital of Southern Medical University

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.


Condition or disease Intervention/treatment Phase
Tooth Diseases Device: Resin blocs (Grandio Blocs, VOCO) Device: Ceramic (Suprinity, VITA) Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Efficacy of Ceramic vs Resin Bloc Endocrowns: Study Protocol for the Randomized Clinical Trial
Actual Study Start Date : May 2, 2019
Estimated Primary Completion Date : May 30, 2021
Estimated Study Completion Date : October 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Disorders

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)




Primary Outcome Measures :
  1. Marginal Adaptation [ Time Frame: 2 years ]
    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 :
  1. Fracture of material and retention: [ Time Frame: 2 years ]
    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. wear [ Time Frame: 2 years ]
    Clinical evaluations were performed at baseline and 24 months according to FDI criteria by 2 independent evaluators.

  3. Recurrence of caries [ Time Frame: 2 years ]
    Clinical evaluations were performed at baseline and 24 months according to FDI criteria by 2 independent evaluators.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04033380


Contacts
Layout table for location contacts
Contact: Wenjuan Yan, PHD 15802018770 645613053@qq.com
Contact: Buling Wu, PHD 02062787149

Locations
Layout table for location information
China, Guangdong
NanFang Hospital, Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510515
Contact: WenJuan Yan, PHD    15802018770    645613053@qq.com   
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Investigators
Layout table for investigator information
Study Chair: Wenjuan Yan, PHD Nanfang Hospital of Southern Medical University

Publications:
Layout table for additonal information
Responsible Party: Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT04033380     History of Changes
Other Study ID Numbers: NanFangH
First Posted: July 26, 2019    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nanfang Hospital of Southern Medical University:
Ceramic, Resin Bloc, Endocrown , Root Canal Treatment, Molar
Additional relevant MeSH terms:
Layout table for MeSH terms
Tooth Diseases
Stomatognathic Diseases