search
Back to results

Functional Evaluation of Ceramic Onlay Restorations With Different Preparation Designs

Primary Purpose

Posterior Ceramic Onlays, Badly Decayed Teeth Need to be Restored , Teeth Restored With Large Filling Restorations

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ceramic onlay with shoulder preparation design.
,ceramic onlay with butt joint preparation design
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posterior Ceramic Onlays

Eligibility Criteria

25 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • From 25-45 years old, be able to read and sign the informed consent document. (31)
  • Have no active periodontal or pulpal diseases, have teeth with good restorations. (32)
  • Psychologically and physically able to withstand conventional dental procedures
  • Patients with teeth problems indicated for posterior onlay.

    1. Decayed teeth
    2. Teeth restored with large filling restorations
  • Able to return for follow-up examinations and evaluation

Exclusion Criteria:

  • Patient less than 25 or more than 45 years
  • Patient with active resistant periodontal diseases
  • Patients with poor oral hygiene, high caries risk and uncooperative patients
  • Pregnant women
  • Patients in the growth stage with partially erupted teeth
  • Psychiatric problems or unrealistic expectations
  • Lack of opposing dentition in the area of interest.
  • The presence of a removable or fixed orthodontic appliance, signs of bruxism or clenching, the absence of more than one unit in the posterior region .

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    ceramic onlay with shoulder preparation design.

    ceramic onlay with butt joint preparation design

    Arm Description

    posterior ceramic onlay restoration with shoulder design with 1 mm shoulder thickness

    posterior ceramic onlay with butt joint preparation design with flat occlusal reduction with inclined surface

    Outcomes

    Primary Outcome Measures

    Fracture
    measured using Modified united states public health service criteira (MUSPHS)

    Secondary Outcome Measures

    Marginal adaptation
    measured using Modified united states public health service criteira (MUSPHS)

    Full Information

    First Posted
    February 16, 2020
    Last Updated
    February 17, 2020
    Sponsor
    Cairo University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04274959
    Brief Title
    Functional Evaluation of Ceramic Onlay Restorations With Different Preparation Designs
    Official Title
    Functional Evaluation of Ceramic Onlay Restorations With Different Preparation Designs
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 20, 2020 (Anticipated)
    Primary Completion Date
    February 1, 2021 (Anticipated)
    Study Completion Date
    June 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo 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
    Tooth preparation designs for posterior ceramic restorations have been based on traditional cast metal restoration designs, but with more occlusal tooth reduction and with a slightly increased taper. These preparations may involve the removal of considerable tooth structure. As more structure is removed, higher tooth strain and lower fracture resistance may occur.5 The increased tooth structure loss may increase cuspal flexure, thereby reducing the tooth fracture resistance, or open the restoration-tooth interface . However, it has been demonstrated that cusp recovery results in fewer failures, likely increasing the longevity of posterior ceramic restorations. Recently, minimally invasive cavity preparations for posterior indirect restorations were demonstrated to present the benefit of conservation of tooth structure, as well as improved stress distribution. However, the performance of posterior restoration is also material dependent. Due to the continuous advancements in dental ceramics and innovative manufacturing techniques. The aim of this study is to evaluate the clinical functional performance of ceramic onlay restorations with butt joint preparation design and compare them to shoulder preparation design.
    Detailed Description
    When an indirect restoration is selected as the treatment option for posterior teeth, the clinician must determine the configuration of the cavity preparation. Several designs have been proposed for preparing all-ceramic resin-bonded posterior restorations, as guided by the particular mechanical and structural characteristics of ceramic restorative materials. mechanical and structural characteristics of ceramic restorative materials. The primary causes of failure of ceramic onlay restorations are cohesive bulk fractures and marginal deficiencies, which manifest clinically as marginal discoloration and secondary caries. Tooth preparation designs for posterior ceramic restorations have been based on traditional cast metal restoration designs, but with more occlusal tooth reduction and with a slightly increased taper. These preparations may involve the removal of considerable tooth structure. As more structure is removed, higher tooth strain and lower fracture resistance may occur.5 The increased tooth structure loss may increase cuspal flexure, thereby reducing the tooth fracture resistance, or open the restoration-tooth interface . However, it has been demonstrated that cusp recovery results in fewer failures, likely increasing the longevity of posterior ceramic restorations. Recently, minimally invasive cavity preparations for posterior indirect restorations were demonstrated to present the benefit of conservation of tooth structure, as well as improved stress distribution. However, the performance of posterior restoration is also material dependent. Due to the continuous advancements in dental ceramics and innovative manufacturing techniques. Maximum preservation of sound tooth structure and maintenance of the vitality of restored teeth is critical for the longevity of teeth as well as restorations, especially in cases, where a large amount of tooth tissue has been lost due to wear and/or trauma. As the demand for conservative tooth treatment increases, so does the need for partial ceramic crowns. In addition to traditional cusp capping, simplified designs have been recommended in certain cases, such as fractured teeth and teeth with large caries.. According to the cusp coverage, the types of restorations can be classified as inlays, which is not covered cusps, onlays, which is covered at least one cusp, or overlays, and which is covered all cusps. Onlay restorations not only provide superior esthetics but also minimize tooth tissue loss, making them a good treatment choice for posterior teeth with extensive cavities formed due to caries. Moreover, by covering more than one tooth cusp, onlays provide a favorable distribution of stress, reducing the risk of tooth and restoration fracture. preparation design may also play a role in tooth/restoration fracture. Some authors have shown that occlusal reduction reduces the chance of restoration failure. Others have shown that large preparation designs results in a reduced chance of possible fracture occurred in tooth tissue. While different preparation designs have been described in the literature, the most appropriate design will vary according to the restorative material to be used. Despite the fact that partial ceramic crowns are increasingly advocated as alternative restorations for extensively damaged teeth, the literature includes limited studies examining the use of different preparation designs with this type of restoration. To date, confusing and contradictory results have been obtained regarding the effects of preparation design on the fracture resistance and stress distribution of tooth structure restored with partial ceramic crowns. Therefore, this study investigated the effects of three different preparation designs on the fracture of ceramic onlays. The hypothesis that different designs would affect the fracture resistance of onlay restorations.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Posterior Ceramic Onlays, Badly Decayed Teeth Need to be Restored , Teeth Restored With Large Filling Restorations

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    double (participant, outcomes assessor) double blind
    Allocation
    Randomized
    Enrollment
    39 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ceramic onlay with shoulder preparation design.
    Arm Type
    Active Comparator
    Arm Description
    posterior ceramic onlay restoration with shoulder design with 1 mm shoulder thickness
    Arm Title
    ceramic onlay with butt joint preparation design
    Arm Type
    Experimental
    Arm Description
    posterior ceramic onlay with butt joint preparation design with flat occlusal reduction with inclined surface
    Intervention Type
    Other
    Intervention Name(s)
    ceramic onlay with shoulder preparation design.
    Intervention Description
    ceramic onlay with shoulder preparation design which allowing the largest possible enamel for adhesion ,
    Intervention Type
    Other
    Intervention Name(s)
    ,ceramic onlay with butt joint preparation design
    Intervention Description
    ceramic onlay with butt joint preparation design with cusp reduction to protect teeth from occlusal loads and cuspal fracture
    Primary Outcome Measure Information:
    Title
    Fracture
    Description
    measured using Modified united states public health service criteira (MUSPHS)
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Marginal adaptation
    Description
    measured using Modified united states public health service criteira (MUSPHS)
    Time Frame
    1 year
    Other Pre-specified Outcome Measures:
    Title
    Patient satisfaction
    Description
    measured using(Questionnaire) VAS*( * Visual Analog Scale)
    Time Frame
    1year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: From 25-45 years old, be able to read and sign the informed consent document. (31) Have no active periodontal or pulpal diseases, have teeth with good restorations. (32) Psychologically and physically able to withstand conventional dental procedures Patients with teeth problems indicated for posterior onlay. Decayed teeth Teeth restored with large filling restorations Able to return for follow-up examinations and evaluation Exclusion Criteria: Patient less than 25 or more than 45 years Patient with active resistant periodontal diseases Patients with poor oral hygiene, high caries risk and uncooperative patients Pregnant women Patients in the growth stage with partially erupted teeth Psychiatric problems or unrealistic expectations Lack of opposing dentition in the area of interest. The presence of a removable or fixed orthodontic appliance, signs of bruxism or clenching, the absence of more than one unit in the posterior region .
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    nora alsedawy, M.D.s
    Phone
    01140673739
    Email
    nora.alsedawy@dentistry.cu.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    omaima elmahalawi, professor
    Phone
    01222154399
    Email
    oelmahallawi@dentistry.cu.edu.eg
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    nora alsedawy, M.D.s
    Organizational Affiliation
    Cairo University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Functional Evaluation of Ceramic Onlay Restorations With Different Preparation Designs

    We'll reach out to this number within 24 hrs