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

NCT07500636 | Completed

• 1 other identifier: E-9 (2)
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Gingival Health; Metal Ceramic Restorations

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Clinical parameters

  Records were made for the gingival condition of test and control 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. Gingival pocket depth measured in millimeters 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. Gingival recession was measured as distance in millimeters (mm) from the cementoenamel junction to the gingival margin, with the greatest value recorded.

  8 years

Study Arms (1)

Participant with 1 metal-ceramic crown (test)and nonrestored natural tooth in oral cavity (control)

ACTIVE COMPARATOR

A patient (who visits the department's clinic) with a clinical necessity and his own choice to make a metal-ceramic crown (test group) for incisors, canines, premolars, and molars, but has a non-restored corresponding natural tooth on the opposite side of the mouth (control group)

Other: Preparation of a metal-ceramic crown and determination of clinical gingival indicators

Interventions

Preparation of a metal-ceramic crown and determination of clinical gingival indicators OTHER

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.

Participant with 1 metal-ceramic crown (test)and nonrestored natural tooth in oral cavity (control)

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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. With removable prostheses in both jaws. Smokers (\>20 cigarettes per day). With an extraction wound next to an exposed tooth. With neurological or psychiatric problems that affect hygiene.

Sponsors & Collaborators

• Riga Stradins University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dentist, Assistant

Model Details: Split mouth design to evaluate the effects of metal-ceramic (MC) crowns on periodontal tissues by comparing them with the periodontal tissues of a contralateral tooth in the same oral cavity

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: March 30, 2026
• Study Start: October 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2024
• Last Updated: March 30, 2026

Record last verified: 2026-03