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Health of Peri-implant Tissues Adjacent to Zirconia

NCT05081076 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-12-11

No results posted yet for this study

Summary

Background: The control and maintenance of implants, bone tissue and soft tissue are fundamental for the clinical success of implant prostheses (PSIs). The type of ceramic surface finish can modify the biological response of peri-implant tissues adjacent to PSIs over time.

Objective: To prospectively assess whether the peri-implant health of soft and hard tissues adjacent to monolithic zirconia PSIs varies with the type of surface finish (glazed or polished). It will also be evaluated if the patient perceives any clinical, comfort or satisfaction difference.

Methodology: The study design is a randomized, prospective, paired clinical trial, with intra-subject comparison. The sample will consist of consecutive patients in need and indication for treatment with monolithic zirconia PSIs, attended at the Military Policlinic of Porto Alegre and in a private practice by a single specialist researcher. For each PSI, the allocation of a glazed or polished surface in contact with the soft gingival tissue will be randomized on the mesial and distal sides of the crown. Data will be collected by routine clinical and radiographic examination with a focus on peri-implant health (hygiene index, gingival bleeding index, crestal bone level), satisfaction questionnaire and intraoral images (thermography and photographs), after one week of installation of the PSI and in six months, one year and two years. The data will be analyzed by descriptive and inferential statistics, at the significance level of 0.05.

Conditions

  • Peri-Implantitis

Interventions

DEVICE

Glazing

The zirconia surface will be submitted to a vitrification procedure (glazing) in a specific ceramic oven using the Ceramill Stain \& Glaze Kit, following the manufacturer's instructions.

DEVICE

Polishing

The zirconia surface will be submitted to a polishing procedure using a polishing rubbers kit in the sequence indicated by the manufacturer (EVE DIACERA Finishing and Polishing Kit, EVE Ernst Vetter GmbH - Germany).

Sponsors & Collaborators

  • Pontificia Universidade Católica do Rio Grande do Sul

    lead OTHER

Principal Investigators

  • Rosemary SA Shinkai, DDS, PhD · Pontificia Universidade Católica do Rio Grande do Sul (PUCRS)

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-15
Primary Completion
2023-07-31
Completion
2023-09-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05081076 on ClinicalTrials.gov