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

May 22, 2026 updated by: Elīna Bluma, Riga Stradins University

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.

Study Overview

Status

Enrolling by invitation

Conditions

Study Type

Observational

Enrollment (Estimated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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.

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Participants with metal-ceramic crowns and contralateral tooth evaluated in split-mouth design

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8-10 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gingival Pocket Depth Around Metal-Ceramic Crown and Contralateral Tooth
Time Frame: 8-10 Years
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.
8-10 Years
Gingival Recession Around Metal-Ceramic Crown and Contralateral Tooth
Time Frame: 8-10 Years
Gingival recession was measured as distance in millimeters (mm) from the cementoenamel junction to the gingival margin, with the greatest value recorded.
8-10 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riga Stradins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

May 15, 2026

First Submitted That Met QC Criteria

May 22, 2026

First Posted (Actual)

May 28, 2026

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • E-9(2)/1/2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

CC BY NC-ND (possible)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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