This Trial Will Evaluate the Clinical Performance of Onlay Restorations Fabricated Using Rubber Dam Scanning Techniques.

Inlays Clinical Trial

Official title:

Clinical and Laboratory Evaluation of Cad-cam Restorations Fabricated From Digital Impression Under Rubber Dam Isolation (Randomized Clinical Trial & In-vitro Study)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05978440
• Other study ID #: 0682-05/2023 IRB 00010556
• Secondary ID: IRB 00010556
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 25, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: July 2023
• Source: Alexandria University
• Contact: hossam M kamel
• Phone: 012858734310
• Email: hosam.kamel[@]alexu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study will be to evaluate the clinical performance of CAD-CAM onlay restorations fabricated using rubber dam scanning techniques up to 12 months and laboratory investigation of their marginal fit.

Description:

A total of 54 molars will be prepared for CAD-CAM onlay restorations. The preparations will be divided into three groups according to the technique of scanning. Group I: 18 preparations will be scanned without rubber dam using standard technique, group II: 18 preparations will be scanned under rubber dam isolation using cut technique, and group III: 18 preparations will be scanned under rubber dam isolation using lock technique. Final restorations will be milled, checked and cemented, then will be evaluated using the modified FDI criteria at baseline, three months, six months, and one year.

Thirty resin dies will be 3D printed after scanning of a first molar tooth prepared for onlay. The dies will be scanned after they fit in a typodont and grouped with the same technique (n=10 per group). The digital scans will be superimposed using a 3D best-fit alignment method and 3D deviation will be calculated for each group itself and to the other groups. The marginal fit of the restorations produced will be checked using two methods: Triple scan and measuring the cement thickness after cementation and sectioning of the samples.

All data will be collected, and statistically analyzed using suitable tests.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 54
• Est. completion date: December 30, 2024
• Est. primary completion date: November 25, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Healthy adult patients (18-45 years old).

2. Patients in need of class II (OM or OD) caries in molar teeth with initial, moderate or extensive stage according to the staging of caries lesions in The International Caries Detection and Assessment system (ICDASTM codes 2 to 6) (32,33).

3. Presence of proximal caries in digital x-ray with score 2 to 4 according to the ICDAS/ICCMS™ radiographic scoring system(32,33).

4. Vital teeth with absence of clinical signs and symptoms of periapical pathology.

5. Patient Ability to tolerate Rubber Dam applications.

6. Patients who will agree to attend regular check-ups.

Exclusion Criteria:

1. Bad oral hygiene (Grade 3)(34).

2. Non- vital teeth or endodontically treated teeth.

3. Severe Periodontal problems (pockets =6mm).

4. Patients with para-functional habits (e.g., Bruxism, attrition, wear facets)

Related Conditions & MeSH terms

• Inlays

Intervention

Procedure:
• onlay preparation
CAD-CAM onlay restorations will be fabricated using rubber dam scanning techniques and evaluated clinically up to 12 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the clinical performance of CAD-CAM onlay restorations fabricated using rubber dam scanning.	Restorations will be evaluated according to three main domains: (40); Functional (domain F): fracture of material and retention(F1), marginal adaptation(F2), proximal contact point(F3), Form and contour(F4), and Occlusion and wear(F5).; Biological (domain B): Caries at restoration margins(B1), dental hard tissue defects at restoration margin(B2), postoperative hypersensitivity/pulp status(B3).; Aesthetics (domain A): Surface luster and surface texture(A1), Marginal staining(A2), Color match(A3).	12 months