NCT07500636

Long-Term Periodontal Tissue Changes Associated With Metal-Ceramic Crowns: An 8-Year Split-Mouth Study

Long-Term Assessment of Periodontal Tissue Health Following Metal-Ceramic Crown Use: Complication Rates and Prevention Strategies

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Riga Stradins University · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial 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 receive 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: will be invited for gingival examination 3 months after receiving the metal-ceramic crown, will receive a routine hygiene instruction, will be invited for gingival re-examination after 8 years.

Detailed description

The aim of this study is to evaluate the effects of metal-ceramic (MC) crowns on periodontal tissues over 8-year period, using a split-mouth design by comparing treated teeth with contralateral teeth within the same oral cavity. The preparation and manufacturing of the MC crown is performed following a standardized clinical and laboratory protocol. Tooth preparation follow routine requirements, including creation of a chamfer preparation line and placing the crown margin equigingivally. An initial follow-up examination is performed three months after the placement of the MC crown. The examination is performed by a prosthodontist under a dental operating light, using a flat-surfaced intra-oral mirror and a dental/periodontal probe. Both the restored tooth (test) and the contralateral natural tooth (control) are examined. Attention is paid to examin the gingival tissue determining the degree of gum inflammation, the amount of plaque around the crown. The depth of the gum pockets are measured and the amount of recession is determined. Inspection records are made twice, 3 months and 8 years after the placement of MC crowns. All data are confidential and are used only within the framework of the study. Participation is voluntary. Patient have the option to withdraw their participation in the study at any time. This will not affect further treatment at institution. If patients have any questions about the study they are invited to contact: call or visit the Clinic of Prosthetic Dentistry/ RSU Institute of Stomatology.

Conditions

• Gingival Health
• Metal-Ceramic Restorations

Interventions

Type	Name	Description
DEVICE	Metal-ceramic crown	The preparation and manufacturing of the MC crown was performed following a standardized clinical and laboratory protocol. Final impression was taken with a one-step technique in a standard tray. All crowns were manufactured in the same dental laboratory. The metal frameworks were fabricated in cobalt-chromium using the lost-wax technique and then veneered with ceramic using a layering technique. All restorations were cemented with zinc phosphate cement. The examination was performed under a dental operating light, using a flat-surfaced intra-oral mirror and a dental/periodontal probe. Both the restored tooth (test) and the contralateral natural tooth (control) were examined. Records were made for the gingival condition using the Silness \& Loe gingival index. Gingival pocket depth measured in millimeters, gingival recession was measured as distance in millimeters (mm) from the cementoenamel junction to the gingival margin.

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-09-01
• Completion: 2024-09-01
• First posted: 2026-03-30
• Last updated: 2026-04-03