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
About this trial
This is an interventional treatment trial for Posterior Ceramic Onlays
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 .
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
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
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Functional Evaluation of Ceramic Onlay Restorations With Different Preparation Designs
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