Gingival HealthNCT07611461
The Effect of Fixed Dentures on Periodontal Tissues in Long-term.
An observational study of Gingival Health and Metal Ceramic Restorations, run by Riga Stradins University at 1 site in Latvia.
Trial summary
The goal of this observational study is to to evaluate the periodontal condition around metal-ceramic crown. The main question to be answered is: whether the metal-ceramic crown is the cause of gum changes? The study offers to involve patients who have received single metal-ceramic crown and have kept the same tooth… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Gingival Health, Metal Ceramic Restorations
- How many people
- 75 participants
- Where
- 1 siteLatvia
- Study dates
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study included patients who attended the Department of Prosthetic Dentistry at the Rīgas Stradiņš University Institute of Stomatology for restoration of a single tooth with a metal-ceramic (MC) crown, had available patient records, responded to the invitation, and possessed a preserved, non-restored contralateral tooth to serve as a control.
Who may be able to join
- Patients with a tooth-based metal-ceramic crown intended.
- Patients with a good general state of health, i.e. do not suffer from chronic uncontrolled general illnesses (diabetes, cardiovascular diseases, oncological diseases).
- Patients who have corresponding natural tooth on opposite side without a fixed dental prosthesis (crown, bridge).
Who cannot join
- Pregnancy.
- With local inflammation and diseases of the oral mucosa.
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: Evaluation of Periodontal Tissues Associated With Metal-Ceramic Crowns: A Split-Mouth Design
The goal of this observational study is to to evaluate the periodontal condition around metal-ceramic crown. The main question to be answered is: whether the metal-ceramic crown is the cause of gum changes? The study offers to involve patients who have received single metal-ceramic crown and have kept the same tooth intact on the other side of the mouth.The condition of the gums around the crown will be compared with the corresponding natural teeth on the oposite side of the mouth. Clinical parameters such as plaque accumulation, bleeding on probing, periodontal pocket depth and gingival recession will be evaluated. All procedures are part of routine dental examination. Participants: patients who have previously received treatment with metal-ceramic crowns and agree to undergo a gingival examination.
- Conditions
- Gingival Health, Metal Ceramic Restorations
- Keywords
- metal-ceramic, gingival index, pocket probing depth, gingival health, recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants with metal-ceramic crowns and contralateral tooth evaluated in split-mouth design | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival Index Around Metal-Ceramic Crown and Contralateral Tooth
Records were made for the gingival condition of test tooth (metal-ceramic) and control tooth using the Silness \& Loe gingival index, scoring four sites (M, D, B, L) for each tooth. The mean value for each tooth was then calculated. Gingival index (GI) according to Silness \& Loe. Scores Description 0-Normal gingiva, 1-Mild inflammation: slight change in color, slight edema, no bleeding on probing, 2-Moderate inflammation: redness, edema, and glazing, or bleeding on probing, 3-Severe inflammation: marked redness and edema, tendency toward spontaneous bleeding.
Measured: 8-10 Years
Secondary outcomes (2)
Gingival Pocket Depth Around Metal-Ceramic Crown and Contralateral Tooth
Gingival pocket depth measured in millimeters (mm) was assessed at 6 surfaces per tooth by inserting a dental probe between teeth and gumline and recording the distance from the gingival margin to the base of the pocket, with the deepest measurement considered.
Measured: 8-10 Years
Gingival Recession Around Metal-Ceramic Crown and Contralateral Tooth
Gingival recession was measured as distance in millimeters (mm) from the cementoenamel junction to the gingival margin, with the greatest value recorded.
Measured: 8-10 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study startMay 2026 (estimated)
- 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 Gingival HealthStudies 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
- 75 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07611461
- Sponsor's protocol ID
- E-9(2)/1/2
- Status last verified
- May 2026
- First submitted
- 15 May 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: CC BY NC-ND (possible)
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Periodontal Tissues Associated With Metal-Ceramic Crowns: A Split-Mouth Design
- ClinicalTrials.gov ID
- NCT07611461
- Acronym / sponsor ID
- E-9(2)/1/2
- Conditions
- Gingival Health, Metal Ceramic Restorations
- Keywords
- metal-ceramic, gingival index, pocket probing depth, gingival health, recession
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Riga Stradins UniversityUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 28 May 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.
The goal of this observational study is to to evaluate the periodontal condition around metal-ceramic crown. The main question to be answered is: whether the metal-ceramic crown is the cause of gum changes? The study offers to involve patients who have received single metal-ceramic crown and have kept the same tooth intact on the other side of the mouth.The condition of the gums around the crown will be compared with the corresponding natural teeth on the oposite side of the mouth. Clinical parameters such as plaque accumulation, bleeding on probing, periodontal pocket depth and gingival recession will be evaluated. All procedures are part of routine dental examination. Participants: patients who have previously received treatment with metal-ceramic crowns and agree to undergo a gingival examination.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with metal-ceramic crowns and contralateral tooth evaluated in split-mouth design | – | – |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study included patients who attended the Department of Prosthetic Dentistry at the Rīgas Stradiņš University Institute of Stomatology for restoration of a single tooth with a metal-ceramic (MC) crown, had available patient records, responded to the invitation, and possessed a preserved, non-restored contralateral tooth to serve as a control.
Key inclusion criteria (3 listed)
- Patients with a tooth-based metal-ceramic crown intended.
- Patients with a good general state of health, i.e. do not suffer from chronic uncontrolled general illnesses (diabetes, cardiovascular diseases, oncological diseases).
- Patients who have corresponding natural tooth on opposite side without a fixed dental prosthesis (crown, bridge).
Key exclusion criteria (2 listed)
- Pregnancy.
- With local inflammation and diseases of the oral mucosa.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gingival Index Around Metal-Ceramic Crown and Contralateral Tooth
Time frame: 8-10 Years
Records were made for the gingival condition of test tooth (metal-ceramic) and control tooth using the Silness \& Loe gingival index, scoring four sites (M, D, B, L) for each tooth. The mean value for each tooth was then calculated. Gingival index (GI) according to Silness \& Loe. Scores Description 0-Normal gingiva, 1-Mild inflammation: slight change in color, slight edema, no bleeding on probing, 2-Moderate inflammation: redness, edema, and glazing, or bleeding on probing, 3-Severe inflammation: marked redness and edema, tendency toward spontaneous bleeding.
2 secondary outcomes
Gingival Pocket Depth Around Metal-Ceramic Crown and Contralateral Tooth
Time frame: 8-10 Years
Gingival Recession Around Metal-Ceramic Crown and Contralateral Tooth
Time frame: 8-10 Years
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 28 May 2026.
- Individual participant dataSharing planned: Undecided. CC BY NC-ND (possible)
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Gingival Health and Metal Ceramic Restorations, 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 3 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 28 May 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?
Gingival Index Around Metal-Ceramic Crown and Contralateral Tooth (time frame: 8-10 Years). 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 28 May 2026.