Skip to content

Influence of Zirconia Abutments on Peri-Implant Tissues in Single-Tooth Restorations

Potential Influence of Pre-fabricated and Customized Anatomical Zirconia Abutments in the Peri-implant Region for Single-tooth Implant-supported Prosthetic Restorations

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07456163
Enrollment
71
Registered
2026-03-06
Start date
2025-04-30
Completion date
2027-12-01
Last updated
2026-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Implant Complication, Peri-Implant Health, Prosthesis and Implants

Keywords

Dental Prosthesis, Connection, Dental Implant-Abutment, Dental Porcelain, Biofilm

Brief summary

Objectives: To compare the influence of pre-fabricated titanium abutments and customized milled zirconia abutments on implant biocompatibility and the peri-implant region, as well as on radiographic bone loss and oral health-related quality of life. Detailed Methodology: This study is a randomized controlled clinical trial designed to evaluate the biological and clinical behavior of standardized titanium abutments compared with customized anatomical zirconia abutments in single implant-supported posterior restorations. The present investigation represents the prosthetic phase of a previously conducted randomized clinical trial that evaluated dimensional changes following different alveolar preservation protocols in posterior regions (CAAE: 59208422.8.0000.5418). In the previous phase, participants underwent tooth extraction and alveolar preservation procedures, followed by implant placement with Morse Taper (CM) implants (Biomorse XP, Bionnovation Biomedical) after a six-month healing period. After implant osseointegration, participants eligible for prosthetic rehabilitation will be randomly allocated to one of two parallel groups using a computer-generated randomization sequence (Sealedenvelope.com). The allocation ratio will be 1:1. Sample size calculation was performed using GPower software to ensure adequate statistical power. The intervention consists of prosthetic rehabilitation with either standardized titanium abutments (TiB group) or customized anatomical zirconia abutments (ZiT group), both supporting single zirconia crowns in posterior regions. All prosthetic and laboratory procedures will follow standardized clinical protocols. Clinical and laboratory assessments will be conducted at prosthesis delivery (baseline) and at 1-, 3-, 6-, and 12-month follow-up visits. Data collection will include peri-implant crevicular fluid (PICF) and biofilm sampling for biomolecular analysis, comprehensive periodontal clinical parameters, measurement of keratinized mucosa thickness, standardized periapical radiographs for marginal bone level assessment, and intraoral digital scanning for volumetric and soft tissue analysis. The primary objective is to compare peri-implant tissue stability and biological response between titanium and zirconia abutments. Secondary outcomes include clinical parameters, marginal bone level changes, and soft tissue dimensional stability over a 12-month follow-up period. This study aims to contribute to the understanding of how abutment material and design may influence peri-implant health and long-term tissue stability in posterior implant-supported restorations.

Detailed description

This study is a randomized controlled clinical trial designed to evaluate the biological and clinical behavior of standardized titanium abutments compared with customized anatomical zirconia abutments in single implant-supported posterior restorations. The present investigation represents the prosthetic phase of a previously conducted randomized clinical trial that evaluated dimensional changes following different alveolar preservation protocols in posterior regions (CAAE: 59208422.8.0000.5418). In the previous phase, participants underwent tooth extraction and alveolar preservation procedures, followed by implant placement with Morse Taper (CM) implants (Biomorse XP, Bionnovation Biomedical) after a six-month healing period. After implant osseointegration, participants eligible for prosthetic rehabilitation will be randomly allocated to one of two parallel groups using a computer-generated randomization sequence (Sealedenvelope.com). The allocation ratio will be 1:1. Sample size calculation was performed using GPower software to ensure adequate statistical power. The intervention consists of prosthetic rehabilitation with either standardized titanium abutments (TiB group) or customized anatomical zirconia abutments (ZiT group), both supporting single zirconia crowns in posterior regions. All prosthetic and laboratory procedures will follow standardized clinical protocols. Clinical and laboratory assessments will be conducted at prosthesis delivery (baseline) and at 1-, 3-, 6-, and 12-month follow-up visits. Data collection will include: Peri-implant crevicular fluid (PICF) and biofilm sampling for biomolecular analysis Comprehensive periodontal clinical parameters Measurement of keratinized mucosa thickness Standardized periapical radiographs for marginal bone level assessment Intraoral digital scanning for volumetric and soft tissue analysis The primary objective is to compare peri-implant tissue stability and biological response between titanium and zirconia abutments. Secondary outcomes include clinical parameters, marginal bone level changes, and soft tissue dimensional stability over a 12-month follow-up period. This study aims to contribute to the understanding of how abutment material and design may influence peri-implant health and long-term tissue stability in posterior implant-supported restorations.

Interventions

DEVICEPre-fabricated standardized titanium abutments

Participants receive prosthetic rehabilitation with manufacturer-provided pre-fabricated standardized titanium abutments connected to previously osseointegrated Morse Taper implants. After abutment placement, single zirconia crowns are installed following standardized digital prosthetic procedures.

DEVICECustomized anatomical zirconia abutments

Participants receive prosthetic rehabilitation with CAD/CAM-fabricated customized anatomical zirconia abutments connected to previously osseointegrated Morse Taper implants. After abutment placement, single zirconia crowns are installed following standardized digital prosthetic procedures.

Sponsors

University of Campinas, Brazil
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

1. Individuals aged 18 years or older; 2. Participants in the Master's Thesis entitled: "Dimensional Changes Following Different Alveolar Preservation Protocols in Posterior Regions: A Randomized Controlled Study"; 3. Patients with implants and healing abutments from Bionnovation Biomedical in place at the time of prosthetic rehabilitation; 4. Implants without surrounding bone loss; 5. Signed informed consent form.

Exclusion criteria

1. Patients with uncontrolled systemic diseases; 2. Pregnant or lactating women; 3. Smokers or former smokers; 4. Undergoing orthodontic treatment; 5. Using medications that interfere with bone healing, such as those for osteoporosis and bisphosphonates; 6. Implants with bone loss or failed implants.

Design outcomes

Primary

MeasureTime frameDescription
Microbial Colonization in Peri-implant Sites1, 3, 6, and 12 months after prosthesis installationQuantitative assessment of bacterial load in peri-implant crevicular fluid samples, expressed as CFU/ml, determined by qPCR analysis.

Secondary

MeasureTime frameDescription
Demographic Characteristics of the Study PopulationBaselineDescriptive analysis of participant demographic variables, including age and sex, reported as means and frequency distribution.

Countries

Brazil

Contacts

CONTACTLeticia Sandoli Arroteia, Ms and PhD Student
leticia.sandoli@hotmail.com+5514981600821
PRINCIPAL_INVESTIGATORRenato Casarin, Associate Professor

University of Campinas, Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026