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

NCT05943782 | Unknown DMC

• 1 other identifier: 052308
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Marginal and internal fit.

  three-dimensional digital evaluation by triple scan protocol in microns

  Immediate after treatment

Secondary Outcomes (1)

• clinical functional evaluation .

  one year

Study Arms (2)

additive manufacturing of onlays

EXPERIMENTAL

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

Procedure: Onlay manufactured by 3D printing

subtractive manufacturing of onlays

ACTIVE COMPARATOR

subtractive CAD/CAM manufacturing of dental restorations by milling

Procedure: onlay manufactured by milling

Interventions

onlay manufactured by milling PROCEDURE

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

subtractive manufacturing of onlays

Onlay manufactured by 3D printing PROCEDURE

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

additive manufacturing of onlays

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Conditions

Dental Caries; Tooth Fractures

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Tooth Injuries; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: July 13, 2023
• Study Start: March 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: May 1, 2025
• Last Updated: February 6, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share