Health of Peri-implant Tissues Adjacent to Zirconia

NCT05081076 | Completed

• 1 other identifier: CAAE 45255621.2.0000.5336
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

monolithic zirconia; dental implants; peri-implant tissues; surface finishing

Outcome Measures

Primary Outcomes (6)

• Change from baseline Hygiene Index at six months

  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

  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

  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

  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

  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

  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 Outcomes (9)

• Change in baseline Overal Satisfaction at six months

  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

  from six months (T1) to one year (T2) of follow-up

• Change in one-year Overal satisfaction at two years

  from one year (T2) to two years (T3) of follow-up

• Change in baseline Infrared thermography score at six months

  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

  from six months (T1) to one year (T2) of follow-up

Study Arms (2)

Glazed surface

ACTIVE COMPARATOR

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

Polished surface

EXPERIMENTAL

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

Interventions

Glazing DEVICE

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.

Glazed surface

Polishing DEVICE

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).

Polished surface

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pontificia Universidade Católica do Rio Grande do Sul: lead

Study Sites (1)

Pontificia Universidade Católica do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90619900, Brazil

Location

Related Publications (4)

• Linkevicius T, Vaitelis J. The effect of zirconia or titanium as abutment material on soft peri-implant tissues: a systematic review and meta-analysis. Clin Oral Implants Res. 2015 Sep;26 Suppl 11:139-47. doi: 10.1111/clr.12631. Epub 2015 Jun 13.

  PMID: 26073346 BACKGROUND

• Berglundh T, Armitage G, Araujo MG, Avila-Ortiz G, Blanco J, Camargo PM, Chen S, Cochran D, Derks J, Figuero E, Hammerle CHF, Heitz-Mayfield LJA, Huynh-Ba G, Iacono V, Koo KT, Lambert F, McCauley L, Quirynen M, Renvert S, Salvi GE, Schwarz F, Tarnow D, Tomasi C, Wang HL, Zitzmann N. 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. J Clin Periodontol. 2018 Jun;45 Suppl 20:S286-S291. doi: 10.1111/jcpe.12957.

  PMID: 29926491 BACKGROUND

• Segalla DB, Villarinho EA, Correia ARM, Vigo A, Shinkai RSA. A within-subject comparison of short implants in the posterior region: retrospective study of up to 10 years. J Adv Prosthodont. 2021 Jun;13(3):172-179. doi: 10.4047/jap.2021.13.3.172. Epub 2021 Jun 25.

  PMID: 34234927 BACKGROUND

• Villarinho EA, Triches DF, Alonso FR, Mezzomo LAM, Teixeira ER, Shinkai RSA. Risk factors for single crowns supported by short (6-mm) implants in the posterior region: A prospective clinical and radiographic study. Clin Implant Dent Relat Res. 2017 Aug;19(4):671-680. doi: 10.1111/cid.12494. Epub 2017 May 10.

  PMID: 28493384 BACKGROUND

MeSH Terms

Conditions

Peri-Implantitis

Interventions

Dental Polishing

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dentistry

Study Officials

• Rosemary SA Shinkai, DDS, PhD

  Pontificia Universidade Católica do Rio Grande do Sul (PUCRS)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The randomisation of surface finishing treatment per side (mesial or distal) of each zirconia crown will be made at the laboratory fabrication step, and the treatment codes will be known only by the certified technician and Projec PI. The clinician, who is also the investigator and outcomes assessor, will not assess the codes until the final data analysis.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study design is a randomized, prospective, paired, clinical trial with intra-subject comparison. Each zirconia crown to be placed over the dental implant has two sides (mesial and distal), which will receive a randomised surface finishing treatment in the laboratory fabrication procedure.

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: October 18, 2021
• Study Start: August 15, 2021
• Primary Completion: July 31, 2023
• Study Completion: September 30, 2023
• Last Updated: December 11, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)