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Enrolling by invitationNCT07611461Updated May 28, 2026

The Effect of Fixed Dentures on Periodontal Tissues in Long-term.

An observational study in Gingival Health and Metal Ceramic Restorations, sponsored by Riga Stradins University. Enrolling by invitation at 1 site in Latvia. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-28.

Sponsored by Riga Stradins University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
75
Ages
20 Years to 75 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Gingival Health
  • Metal Ceramic Restorations

Keywords

  • metal-ceramic
  • gingival index
  • pocket probing depth
  • gingival health
  • recession
03

In context

Lead sponsor

Riga Stradins University is the lead sponsor of 19 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

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.

Inclusion criteria

  • 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).

Exclusion criteria

Exclusion Criteria:

  • Pregnancy.
  • With local inflammation and diseases of the oral mucosa.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
75 participants (estimated)
Patient registry
No

Groups and cohorts

  • Participants with metal-ceramic crowns and contralateral tooth evaluated in split-mouth design
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 8-10 Years

Secondary outcomes

  1. 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.

    Time frame: 8-10 Years

  2. 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.

    Time frame: 8-10 Years

07

Study locations

1 site
  • RSU Institute of Stomatology
    Riga, Dzirciema Iela 20 LV-1007, Latvia
08

References and documents

Individual participant data

Plan to share: Undecided — CC BY NC-ND (possible)

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for May 2026; primary completion for Dec 2026, 7 months later.

How these figures are worked out, and which studies are left out of them.

Registered
May 15, 2026
First posted
May 28, 2026
StartEst.
May 2026
Primary completionEst.
Dec 2026
CompletionEst.
Dec 2026
Last update
May 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07611461
Lead sponsor
Riga Stradins University
Responsible party
Elīna Bluma (Principal Investigator/Certified Prosthodontist, Riga Stradins University) — Principal investigator
First posted
May 28, 2026
Start date
May 2026 (estimated)
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
May 28, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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