Evaluation of CAD/CAM Onlays Fabricated by Subtractive Versus Additive Digital Manufacturing Techniques.

NCT ID: NCT05943782

Last Updated: 2024-02-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2025-05-01

Brief Summary

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.

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.

Conditions

Caries,Dental; Broken Teeth; Fracture Tooth; Defective Dentition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

additive manufacturing of onlays

additive CAD/CAM manufacturing of dental restorations by 3D printing

Group Type: EXPERIMENTAL

Onlay manufactured by 3D printing

Intervention Type: PROCEDURE

indirect restorations for treating mutilated molars manufactured by CAD/CAM additive technique

subtractive manufacturing of onlays

subtractive CAD/CAM manufacturing of dental restorations by milling

Group Type: ACTIVE_COMPARATOR

onlay manufactured by milling

Intervention Type: PROCEDURE

indirect restorations for treating mutilated molars manufactured by CAD/CAM subtractive technique

Interventions

onlay manufactured by milling

indirect restorations for treating mutilated molars manufactured by CAD/CAM subtractive technique

Intervention Type: PROCEDURE

Onlay manufactured by 3D printing

indirect restorations for treating mutilated molars manufactured by CAD/CAM additive technique

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Presence of caries lesion, defective amalgam, or composite restorations in posterior dentition (molars), suitable for the restoration with ceramic onlays.

2. Presence of antagonist tooth.

3. Adult patients (age: 18-50 years) of both genders.

4. Good general and oral health; Able to tolerate necessary restorative procedures and willing to sign an informed consent.

5. Absence of orthodontic appliances.

6. Absence of malocclusion and tooth malformation.

Exclusion Criteria

1. Presence of non-carious cervical lesions.

2. Pregnant women.

3. Allergy to any of the restorative materials.

4. Mobile teeth, indicating periodontal disease or trauma.

5. External or internal resorption.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

052308

Identifier Type: -

Identifier Source: org_study_id