NCT05978440

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 25, 2023

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 7, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

August 7, 2023

Status Verified

July 1, 2023

Enrollment Period

1.3 years

First QC Date

July 30, 2023

Last Update Submit

July 30, 2023

Conditions

Inlays

Outcome Measures

Primary Outcomes (1)

  • Evaluate the clinical performance of CAD-CAM onlay restorations fabricated using rubber dam scanning.

    Restorations 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).

    12 months

Study Arms (3)

Scanning without rubber dam

ACTIVE COMPARATOR

After the onlay preparation, standard digital impression will be recorded for the working quadrant using the IOS without applying the rubber dam. Then the opposing quadrant will be scanned in addition to interocclusal bite registration.

Procedure: onlay preparation

Scanning under rubber dam with cut technique

EXPERIMENTAL

In this group a pre-operative scan will be already taken before the preparation for the working arch, opposing arch and the interocclusal bite registration. Then using the "Cut" feature in the software of the IOS to cut the area of the working tooth. After the preparation, rubber dam will be applied on the working quadrant and then rescan the prepared tooth.

Procedure: onlay preparation

Scanning under rubber dam with new lock technique

EXPERIMENTAL

After the onlay preparation, the rubber dam will be applied to the working quadrant. Digital impression will be taken using the IOS. After that using the "lock" feature in the software of the scanner, all the preparation area and margins will be locked. Rubber dam will be removed, and scanning will be completed for the whole quadrant and opposing arch in addition to interocclusal bite registration.

Procedure: onlay preparation

Interventions

onlay preparationPROCEDURE

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

Scanning under rubber dam with cut techniqueScanning under rubber dam with new lock techniqueScanning without rubber dam

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adult patients (18-45 years old).
  • 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).
  • Presence of proximal caries in digital x-ray with score 2 to 4 according to the ICDAS/ICCMS™ radiographic scoring system(32,33).
  • Vital teeth with absence of clinical signs and symptoms of periapical pathology.
  • Patient Ability to tolerate Rubber Dam applications.
  • Patients who will agree to attend regular check-ups.

You may not qualify if:

  • Bad oral hygiene (Grade 3)(34).
  • Non- vital teeth or endodontically treated teeth.
  • Severe Periodontal problems (pockets ≥6mm).
  • Patients with para-functional habits (e.g., Bruxism, attrition, wear facets)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • hossam m kamel

    Alexandria University

    STUDY CHAIR

Central Study Contacts

hossam M kamel

CONTACT

012858734310hosam.kamel@alexu.edu.eg

-1-*Rania R Afifi

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2023

First Posted

August 7, 2023

Study Start

July 25, 2023

Primary Completion

November 25, 2024

Study Completion

December 30, 2024

Last Updated

August 7, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share