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Enrolling by Invitation

NCT Number: NCT07611461

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

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.

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Key information

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

RSU Institute of Stomatology

Riga, Dzirciema Iela 20, LV-1007, Latvia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Riga Stradins University

Other

Registry information

Official study title

Evaluation of Periodontal Tissues Associated With Metal-Ceramic Crowns: A Split-Mouth Design

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 28, 2026
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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