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

Riga Stradins University

Status: Completed

Conditions: Gingival Health; Metal-Ceramic Restorations

Treatments: Device: Metal-ceramic crown

Study type: Interventional

Funder types: Other

Identifiers

NCT07500636

E-9 (2)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.
• 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

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

Active Comparator group

Description:

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).

Treatment:

Device: Metal-ceramic crown