Evaluation of CAD/CAM Onlays Fabricated by Subtractive Versus Additive Digital Manufacturing Techniques.
Functional Evaluation of CAD/CAM Onlays Fabricated by Subtractive Versus Additive Digital Manufacturing Techniques. A One Year Randomized Clinical Trial.
Aim of the study: The aim of this RCT is to evaluate CAD/CAM onlays fabricated by subtractive technique (brilliant crios) versus additive technique (varseosmile crown plus material), in terms of clinical functional evaluation following the FDI criteria and three-dimensional digital evaluation of the marginal and internal fit by triple scan protocol.
Materials and methods: A total of 30 patients will be enrolled in the clinical trial following the eligibility criteria. Then, the patients will be randomly allocated to receive either 3D printed onlays or milled ones. A blinded operator will prepare a standardized cavity for the restoration and an impression will be performed. After designing the restoration on the Exocad software, A dentist not involved in the clinical part of the study will receive the STL file of the design and envelopes containing the information necessary only to manufacture the restorations (tooth numbers and restorative materials) to proceed with either the milling or printing procedures. Try in and cementation procedures will be similarly performed for both groups by a blinded operator. Finally, the marginal and internal fit will be evaluated by using the triple scan protocol for digital 3D assessment.
Also, a baseline, six months and 12 months assessments will be performed by a blinded examiner, not involved in the clinical part for assessing the functional clinical performance of the re3stprations using the FDI criteria. Finally, the data will be statistically analyzed.
Study Overview
Status
Intervention / Treatment
Detailed Description
Statement of the problem: Several randomized clinical trials (RCT) investigated the clinical performance of milled ceramic and composite posterior indirect adhesive restorations. However, none investigated that of 3D printed ones and the differences in their fabrication process and material properties of these restorations may impact their clinical performance. Therefore, clinical assessment of that novel additive technique is required.
Aim of the study: The aim of this RCT is to evaluate CAD/CAM onlays fabricated by subtractive technique (brilliant crios) versus additive technique (varseosmile crown plus material), in terms of clinical functional evaluation following the FDI criteria and three-dimensional digital evaluation of the marginal and internal fit by triple scan protocol.
Materials and methods: A total of 30 patients will be enrolled in the clinical trial following the eligibility criteria. Then, the patients will be randomly allocated to receive either 3D printed onlays or milled ones. A blinded operator will prepare a standardized cavity for the restoration and an impression will be performed. After designing the restoration on the Exocad software, A dentist not involved in the clinical part of the study will receive the STL file of the design and envelopes containing the information necessary only to manufacture the restorations (tooth numbers and restorative materials) to proceed with either the milling or printing procedures. Try in and cementation procedures will be similarly performed for both groups by a blinded operator. Finally, the marginal and internal fit will be evaluated by using the triple scan protocol for digital 3D assessment.
Also, a baseline, six months and 12 months assessments will be performed by a blinded examiner, not involved in the clinical part for assessing the functional clinical performance of the re3stprations using the FDI criteria. Finally, the data will be statistically analyzed.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt, 11263
- AinShams university
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Presence of caries lesion, defective amalgam, or composite restorations in posterior dentition (molars), suitable for the restoration with ceramic onlays.
- Presence of antagonist tooth.
- Adult patients (age: 18-50 years) of both genders.
- Good general and oral health; Able to tolerate necessary restorative procedures and willing to sign an informed consent.
- Absence of orthodontic appliances.
- Absence of malocclusion and tooth malformation.
Exclusion Criteria:
- Presence of non-carious cervical lesions.
- Pregnant women.
- Allergy to any of the restorative materials.
- Mobile teeth, indicating periodontal disease or trauma.
- External or internal resorption.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: additive manufacturing of onlays
additive CAD/CAM manufacturing of dental restorations by 3D printing
|
indirect restorations for treating mutilated molars manufactured by CAD/CAM additive technique
|
|
Active Comparator: subtractive manufacturing of onlays
subtractive CAD/CAM manufacturing of dental restorations by milling
|
indirect restorations for treating mutilated molars manufactured by CAD/CAM subtractive technique
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Marginal and internal fit.
Time Frame: Immediate after treatment
|
three-dimensional digital evaluation by triple scan protocol in microns
|
Immediate after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
clinical functional evaluation .
Time Frame: one year
|
clinical functional evaluation following the FDI criteria by clinical examination performed by trained investigators
|
one year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 052308
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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