A Retrospective Study on Long-Term Technical Complications of Single Metal-Ceramic Crowns With a Supplementary Questionnaire Survey

NCT07828509 | Enrolling By Invitation

• 1 other identifier: 2-PĒK-4/270/2024
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

This observational study aims to evaluate the long-term clinical outcomes and biological complications associated with metal-ceramic crowns. Patient dental records will be reviewed to identify eligible participants, who will subsequently be invited for a clinical examination. The clinical condition of the metal-ceramic crowns and the supporting teeth and periodontal tissues will be assessed using predefined clinical criteria. The study aims to provide information on the long-term clinical performance of metal-ceramic crowns and the occurrence of associated biological complications. Participants will also compleate a questionaire assessing oral health-related habits and satisfaction with metal ceramic crown.

Conditions

Metal Ceramic Restorations; Gingival Health

Keywords

Technical complications; Questionnaire; Biological complication; Metal-Ceramic crowns

Outcome Measures

Primary Outcomes (1)

• Technical complications of metal-ceramic single crown

  The assessed clinical parameters, based on the modified USPHS criteria, included veneer chipping, wear of the occlusal surface, anatomical form/contour, marginal adaptation, color match, and secondary caries (see Table 1), with the worst recorded score being documented.

  Clinical examination in 2026

Secondary Outcomes (2)

• Biological complications of metal-ceramic single crowns

  Clinical examination in 2026

• Questionnaire on hygiene habits and satisfaction

  Prior clinical examination in 2026

Study Arms (1)

Patients with single Metal-Ceramic crown

Patients who received metal- ceramic single crown and are evaluated for the clinical condition of the restoration and gingival tissues. Patients were asked to complete a modified questionnaire in Latvian organizing the information into the following sections: oral hygiene habits (4 questions), disadvantages/ encumbrances with the crown (3 questions) and satisfaction (1 question) using Likert-style scale.

Device: Metal-Ceramic dental single crown

Interventions

Metal-Ceramic dental single crown DEVICE

Metal - ceramic single crowns previously placed as part of routine dental treatment. No crowns are placed as part of this observational study. The existing restorations and supporting tissues are evaluated during clinical examination. The questionnaire was completed in paper format prior to the clinical examination and in the presence of the clinician. Responses were coded numerically for descriptive purposes, and mean satisfaction scores with standard deviations are reported.

Patients with single Metal-Ceramic crown

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients who received metal-ceramic crowns and were identified through a review of dental records according to predefined eligibility criteria. Eligible patients were invited to participate in a clinical examination and questionnaire assessment.

You may qualify if:

• adult patients with at least one metal-ceramic single crown meeting the predefined study criteria.
• ability and willingness to participate in the clinical examination and complete the questionnaire

You may not qualify if:

• teeth serving as abutments for fixed partial prostheses (FPPs)
• teeth as abutments for removable partial dentures (RPDs)

Sponsors & Collaborators

• Riga Stradins University: lead

Study Sites (1)

Rīga Stradiņš University Institute of Stomatology

Riga, LV 1007, Latvia

Location

Study Officials

• Una Soboļeva, PhD

  Rīga Stradiņš University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 18, 2026
• Study Start: May 25, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 18, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

LA (1)