Clinical and Radiographical Evaluation of CAD-CAM Crowns With and Without Deep Margin Elevation
1 other identifier
interventional
560
1 country
1
Brief Summary
Deep margin elevation (DME) is a non-invasive restorative technique to relocate the deep cervical margin to a supragingival position using resin composite. This retrospective multicenter practice-based study will assess the long-term clinical performance and periodontal health of teeth restored with CAD-CAM crowns with or without DME. Patients who will receive CAD-CAM lithium disilicate (LD) crowns with or without DME between 2013 and 2023 at multiple private practices will be included. When indicated, DME will be performed using resin-based restoration. Clinical assessment of the crowns and supporting periodontal structures will be performed following the modified United States Public Health Service (USPHS) criteria. Intra-oral photographs, periapical and bitewing radiographs will be taken for further assessment by three evaluators. Kaplan Meier survival analyses will be performed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2023
1 active site
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
March 1, 2023
CompletedFirst Submitted
Initial submission to the registry
October 17, 2023
CompletedFirst Posted
Study publicly available on registry
November 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2024
CompletedNovember 2, 2023
October 1, 2023
10 months
October 17, 2023
November 1, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
The survival rate of teeth restored with or without DME and crowns.
Number of survived crowns in the presence or absence of DME
10 years
Number of failed crowns in the presence or absence of DME
10 years
Secondary Outcomes (3)
Change from baseline in pocket depth
10 years
Change from baseline in bleeding of probing
10 years
Periodontal responses in response to deep (subgingival) margins
10 years
Study Arms (1)
Deep margin elevation followed by crowns
OTHERTeeth restored with DME and crowns
Interventions
Restoration of the deep margin by composite restorations such as: Filtek Supreme XTE, Tetric EvoCeram, Estelite Sigma Qquick followed by Lithium disilicate glass-ceramic CAD/CAM crowns (IPS e.max CAD).
Eligibility Criteria
You may qualify if:
- adult patient and indication for crown with or without DME.
You may not qualify if:
- poor oral hygiene and active periodontal disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Sharjah
Sharjah city, 7724, United Arab Emirates
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ahmed M Aziz, PhD
University of Sharjah
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
October 17, 2023
First Posted
November 2, 2023
Study Start
March 1, 2023
Primary Completion
December 30, 2023
Study Completion
January 30, 2024
Last Updated
November 2, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share