An observational study in Metal Ceramic Restorations and Gingival Health, sponsored by Riga Stradins University. Enrolling by invitation at 1 site in Latvia. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by Riga Stradins University · Observational
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 questionnaire assessing oral health-related habits and satisfaction with metal-ceramic crown.
Riga Stradins University is the lead sponsor of 19 studies on the registry; 10 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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.
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, with the worst recorded score (0-3) being documented.
Time frame: Clinical examination in 2026
Secondary Outcome: Gingival Index (GI)
Gingival health was evaluated using the Silness and Löe Gingival Index (GI). The mesial, distal, buccal, and lingual sites of each tooth were scored, and the mean GI value was calculated for each tooth.
Time frame: Clinical examination in 2026
Secondary Outcome: Gingival pocket depth (PD)
Gingival pocket depth was measured in millimeters at six sites around each tooth using a periodontal probe. The distance from the gingival margin to the base of the pocket was recorded, and the deepest measurement was used for analysis.
Time frame: Clinical examination in 2026
Secondary Outcome: Gingival recession (GR)
To assess gingival recession (GR), the distance from the cementoenamel junction (CEJ) to the gingival margin was recorded in millimeters with the greatest value considered for each tooth.
Time frame: Clinical examination in 2026
Oral hygiene and dental care habits
Oral hygiene and dental care habits were assessed using four patient-reported questionnaire items: frequency of dental visits, frequency of tooth brushing per day, mouthwash use, and interdental cleaning practices and types of products. Each item was assessed using predefined response categories and summarized separately using descriptive statistics; no composite score was calculated.
Time frame: Prior to clinical examination in 2026.
Patient-reported problems associated with the metal-ceramic crown
Patient-reported problems associated with the metal-ceramic crown were assessed using three questionnaire items: gingival bleeding around the crown, food impaction between the crown and adjacent tooth (including type of food), and presence of bad breath. Each item was assessed using predefined response categories and summarized separately using descriptive statistics; no composite score was calculated.
Time frame: Prior to clinical examination in 2026.
Patient satisfaction with the metal-ceramic crown
Patient satisfaction with the appearance and function of the metal-ceramic crown was assessed using a 6-point ordinal scale ranging from 0 (completely dissatisfied) to 5 (completely satisfied), with higher scores indicating greater satisfaction.
Time frame: Prior to clinical examination in 2026.
Plan to share: No — Individual participant data are not currently planned to be shared. Study results will be reported in aggregated form in scientific publications.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Riga Stradins University