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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05978440
Enrollment
54
Registered
2023-08-07
Start date
2023-07-25
Completion date
2024-12-30
Last updated
2023-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inlays

Brief 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.

Detailed 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.

Interventions

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

Sponsors

Alexandria University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Evaluate the clinical performance of CAD-CAM onlay restorations fabricated using rubber dam scanning.12 monthsRestorations will be evaluated according to three main domains: (40) 1. 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). 2. Biological (domain B): Caries at restoration margins(B1), dental hard tissue defects at restoration margin(B2), postoperative hypersensitivity/pulp status(B3). 3. Aesthetics (domain A): Surface luster and surface texture(A1), Marginal staining(A2), Color match(A3).

Contacts

Primary Contacthossam M kamel
hosam.kamel@alexu.edu.eg012858734310
Backup Contact-1-*Rania R Afifi

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026