Metal Ceramic RestorationsNCT07828509
A Retrospective Study on Long-Term Technical Complications of Single Metal-Ceramic Crowns With a Supplementary Questionnaire Survey
An observational study of Metal Ceramic Restorations and Gingival Health, run by Riga Stradins University at 1 site in Latvia.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Metal Ceramic Restorations, Gingival Health
- What is being tested?
- Metal-Ceramic dental single crown
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 79 participants
- Where
- 1 siteLatvia
- Study dates
- 25 May 2026to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- teeth serving as abutments for fixed partial prostheses (FPPs)
- teeth as abutments for removable partial dentures (RPDs)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Retrospective Study on Long-Term Technical Complications of Metal-Ceramic Crowns With a Supplementary Questionnaire Survey
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.
- Conditions
- Metal Ceramic Restorations, Gingival Health
- Being tested
- Metal-Ceramic dental single crown
- Keywords
- Technical complications, Questionnaire, Metal-Ceramic crowns, Biological complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metal-Ceramic dental single crownDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Metal-Ceramic dental single crown |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Clinical examination in 2026
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Prior to clinical examination in 2026.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start25 May 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metal Ceramic RestorationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 79 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riga Stradins University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elīna Bluma, Riga Stradins University
- Investigators
- Una Soboļeva, PhD, Principal investigator, Riga Stradins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07828509
- Sponsor's protocol ID
- 2-PĒK-4/270/2024
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not currently planned to be shared. Study results will be reported in aggregated form in scientific publications.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study on Long-Term Technical Complications of Metal-Ceramic Crowns With a Supplementary Questionnaire Survey
- ClinicalTrials.gov ID
- NCT07828509
- Acronym / sponsor ID
- 2-PĒK-4/270/2024
- Conditions
- Metal Ceramic Restorations, Gingival Health
- Keywords
- Technical complications, Questionnaire, Metal-Ceramic crowns, Biological complications
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 79 participants (estimated)
- Lead sponsor
- Riga Stradins UniversityUniversity, hospital or other
- Study start
- 25 May 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with single Metal-Ceramic crown | – | Device: Metal-Ceramic dental single crownPatients 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- teeth serving as abutments for fixed partial prostheses (FPPs)
- teeth as abutments for removable partial dentures (RPDs)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metal-Ceramic dental single crownMetal - 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. | Device | Patients with single Metal-Ceramic crown |
Primary outcome
Technical complications of metal-ceramic single crown
Time frame: Clinical examination in 2026
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.
6 secondary outcomes
Secondary Outcome: Gingival Index (GI)
Time frame: Clinical examination in 2026
Secondary Outcome: Gingival pocket depth (PD)
Time frame: Clinical examination in 2026
Secondary Outcome: Gingival recession (GR)
Time frame: Clinical examination in 2026
Oral hygiene and dental care habits
Time frame: Prior to clinical examination in 2026.
Patient-reported problems associated with the metal-ceramic crown
Time frame: Prior to clinical examination in 2026.
Patient satisfaction with the metal-ceramic crown
Time frame: Prior to clinical examination in 2026.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data are not currently planned to be shared. Study results will be reported in aggregated form in scientific publications.
Related trials for Metal Ceramic Restorations
Enrolling by invitationObservational study
The Effect of Fixed Dentures on Periodontal Tissues in Long-term.
Gingival Health, Metal Ceramic Restorations
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Una Soboļeva, PhD principal investigator
Riga Stradins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metal Ceramic Restorations and Gingival Health, run by Riga Stradins University at 1 site in Latvia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Latvia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical complications of metal-ceramic single crown (time frame: Clinical examination in 2026). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.