Health of Peri-implant Tissues Adjacent to Zirconia

December 8, 2023 updated by: Pontificia Universidade Católica do Rio Grande do Sul

Health of Peri-implant Tissues Adjacent to Glazed or Polished Zirconia Surface: a Randomized, Intra-subject, Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

AIM To prospectively assess whether the peri-implant health of soft and hard tissue adjacent to monolithic PSIs varies with the type of surface finish (glazed or polished).

METHODS The study design is a randomized, prospective, paired, clinical trial with intra-subject comparison, and the research protocol will follow the Resolution 466/12 of the Brazilian National Health Council and the Declaration of Helsinki.

Sample A non-probabilistic sample will consist of consecutive patients in need of treatment with unitary PSIs made of monolithic zirconia, being attended at the Military Polyclinic of Porto Alegre and in a private practice by the same specialist researcher (DBS). Patients will be selected according to the eligibility criteria.

Sample size calculation: In the systematic review of Linkevicius and Vaitelis (2015) on the effect of zirconia or titanium abutments on peri-implant tissues, the 11 clinical studies included for biological outcomes had samples from 11 to 81 patients, with 11 to 45 abutments. In a total of 145 zirconia abutments, 12 (8.2%) had biological complications. There is no current clinical studies on glaze and PSI polishing in monolithic zirconia and outcomes of peri-implant health. So, a priori, the initial sample will consist of 30 PSIs (30 pairs to be compared: Glaze vs. Polishing). The definitive sample size will be calculated after preliminary data analysis from the initial six months of data collection.

PSIs crowns will be made on metallic abutments (Variobase or Anatomic Abutment, Straumann) and milled in monolithic zirconia (Amann Girrbach, Austria), using a CAD/CAM technique with molding or intra-oral scanning and in-lab milling. For each PSI, the mesial and distal faces will receive one experimental treatment (surface finishing) at random, to be defined by drawing lots: glazed surface treatment (Ceramill Stain & Glaze Kit), or polished surface treatment (polishing rubbers kit in the sequence indicated by the manufacturer - EVE DIACERA Finishing and Polishing Kit, EVE Ernst Vetter GmbH - Germany).

All PSIs will be installed according to standardized clinical protocol in the routine of dental clinics where the patients will be seen. After installing the PSI, the clinical data will be collected by clinical-radiographic exam and photographs at the following times: after one week of installation of the PSI (T0 - baseline) and in six months (T1), one year (T2) and two years (T3) of follow-up.

Clinical-radiographic Examination A single trained examiner (D.B.S.) will carry out the collection of clinical and radiographic data for each PSI installed through non-invasive procedures already used in dentistry.

In the clinical exam the following aspects will be evaluated on each face (glazed or polished) of the PSI:

  • Hygiene Index: will be visually evaluated the presence of bacterial plaque (biofilm) and the presence of visible inflammation.
  • Index of Gingival Bleeding: Gingival probe around the zirconia crown, as per the last consensus of Periodontics (Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions).
  • Patient Satisfaction: a 100-mm visual analogue scale will be used
  • Infrared thermography
  • Radiographic evaluation for peri-implant levels analysis (potential bone loss)

Statistical analysis The data will be analyzed by descriptive and inferential statistics (alpha = 0.05).

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 90619900
        • Pontificia Universidade Católica do Rio Grande do Sul

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healing time of at least two months for patients who underwent extraction in areas to be rehabilitated with implants
  • Adequate bone volume at the implant site (ie, sufficient for placement of an implant of at least 3.3 mm in diameter and 6 mm in length) assessed by preoperative CT and clinical evaluation.
  • Use of Straumann bone level or conical bone level implants, with NC or RC platforms.

Exclusion Criteria:

  • Patients with systemic diseases (e.g., heart disease, leukocyte and coagulation disorders, metabolic disorders, immunosuppression)
  • History of radiotherapy in the head and neck region
  • Current treatment with steroids and/or bisphosphonates
  • Neurological or psychiatric impairment that can interfere with good oral hygiene
  • Smoking (more than 10 cigarettes a day)
  • History of illicit drug or alcohol abuse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Glazed surface
One side of the zirconia crown will receive glazed surface treatment according to standard laboratory procedure and manufacturer's recommendations (Ceramill Stain & Glaze Kit).
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.
Experimental: Polished surface
The contralateral side of the zirconia crown will receive polished surface treatment (polishing rubbers kit in the sequence indicated by the manufacturer - EVE DIACERA Finishing and Polishing Kit, EVE Ernst Vetter GmbH - Germany).
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline Hygiene Index at six months
Time Frame: from one week of installation of the PSI (T0 - baseline) to six months (T1) of follow-up
Hygiene Index: will be visually evaluated the presence of bacterial plaque (biofilm) and the presence of visible inflammation
from one week of installation of the PSI (T0 - baseline) to six months (T1) of follow-up
Change from six-month Hygiene Index at one year
Time Frame: from six months (T1) to one year (T2) of follow-up
Hygiene Index: will be visually evaluated the presence of bacterial plaque (biofilm) and the presence of visible inflammation
from six months (T1) to one year (T2) of follow-up
Change from one-year Hygiene Index at two years
Time Frame: from one year (T2) to two years (T3) of follow-up
Hygiene Index: will be visually evaluated the presence of bacterial plaque (biofilm) and the presence of visible inflammation
from one year (T2) to two years (T3) of follow-up
Change from baseline Index of Gingival Bleeding at six months
Time Frame: from one week of installation of the PSI (T0 - baseline) to in six months (T1) of follow-up
Index of Gingival Bleeding: Gingival probe around the zirconia crown, as per the last consensus of Periodontics (Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions)
from one week of installation of the PSI (T0 - baseline) to in six months (T1) of follow-up
Change from six-month Index of Gingival Bleeding at one year
Time Frame: from six months (T1) and one year (T2) of follow-up
Index of Gingival Bleeding: Gingival probe around the zirconia crown, as per the last consensus of Periodontics (Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions)
from six months (T1) and one year (T2) of follow-up
Change from one-year Index of Gingival Bleeding at two years
Time Frame: from one year (T2) to two years (T3) of follow-up
Index of Gingival Bleeding: Gingival probe around the zirconia crown, as per the last consensus of Periodontics (Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions)
from one year (T2) to two years (T3) of follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in baseline Overal Satisfaction at six months
Time Frame: from one week of installation of the PSI (T0 - baseline) to in six months (T1) of follow-up
Patient Satisfaction: a 100-mm visual analogue scale will be used
from one week of installation of the PSI (T0 - baseline) to in six months (T1) of follow-up
Change in six-month Overal satisfaction at one year
Time Frame: from six months (T1) to one year (T2) of follow-up
Patient Satisfaction: a 100-mm visual analogue scale will be used
from six months (T1) to one year (T2) of follow-up
Change in one-year Overal satisfaction at two years
Time Frame: from one year (T2) to two years (T3) of follow-up
Patient Satisfaction: a 100-mm visual analogue scale will be used
from one year (T2) to two years (T3) of follow-up
Change in baseline Infrared thermography score at six months
Time Frame: from one week of installation of the PSI (T0 - baseline) to six months (T1) of follow-up
Infrared termograms obtained from a portable infrared camera will be assessed with the dedicated software to obtain a score measure of each region of interest after calibration procedures
from one week of installation of the PSI (T0 - baseline) to six months (T1) of follow-up
Change in six-month Infrared thermography score at one year
Time Frame: from six months (T1) to one year (T2) of follow-up
Infrared termograms obtained from a portable infrared camera will be assessed with the dedicated software to obtain a score measure of each region of interest after calibration procedures
from six months (T1) to one year (T2) of follow-up
Change in one-year Infrared thermography score at two years
Time Frame: from one year (T2) to two years (T3) of follow-up
Infrared termograms obtained from a portable infrared camera will be assessed with the dedicated software to obtain a score measure of each region of interest after calibration procedures
from one year (T2) to two years (T3) of follow-up
Change in baseline Bone loss at six months
Time Frame: from one week of installation of the PSI (T0 - baseline) to six months (T1) of follow-up
Radiographic images will be analysed with a specific software for peri-implant level measurements at the vertical implant axis, at the mesial and distal sides
from one week of installation of the PSI (T0 - baseline) to six months (T1) of follow-up
Change in six-month Bone loss at one year
Time Frame: from six months (T1) to one year (T2) of follow-up
Radiographic images will be analysed with a specific software for peri-implant level measurements at the vertical implant axis, at the mesial and distal sides
from six months (T1) to one year (T2) of follow-up
Change in one-year Bone loss at two years
Time Frame: from one year (T2) to two years (T3) of follow-up
Radiographic images will be analysed with a specific software for peri-implant level measurements at the vertical implant axis, at the mesial and distal sides
from one year (T2) to two years (T3) of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pontificia Universidade Católica do Rio Grande do Sul

Investigators

  • Study Chair: Rosemary SA Shinkai, DDS, PhD, Pontificia Universidade Catolica do Rio Grande do Sul (PUCRS)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2021

Primary Completion (Actual)

July 31, 2023

Study Completion (Actual)

September 30, 2023

Study Registration Dates

First Submitted

September 14, 2021

First Submitted That Met QC Criteria

October 4, 2021

First Posted (Actual)

October 18, 2021

Study Record Updates

Last Update Posted (Actual)

December 11, 2023

Last Update Submitted That Met QC Criteria

December 8, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAAE 45255621.2.0000.5336

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD may be shared with other researchers upon justified request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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