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

NCT07611461 | Enrolling By Invitation

• 1 other identifier: E-9(2)/1/2
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gingival Health; Metal Ceramic Restorations

Keywords

metal-ceramic; gingival index; pocket probing depth; gingival health; recession

Outcome Measures

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.

  8-10 Years

Secondary Outcomes (2)

• Gingival Pocket Depth Around Metal-Ceramic Crown and Contralateral Tooth

  8-10 Years

• Gingival Recession Around Metal-Ceramic Crown and Contralateral Tooth

  8-10 Years

Study Arms (1)

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

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Riga Stradins University: lead

Study Sites (1)

RSU Institute of Stomatology

Riga, Dzirciema Iela 20, LV-1007, Latvia

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator/Certified Prosthodontist

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: May 28, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 28, 2026

Record last verified: 2026-05

Locations

LA (1)