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

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.

Study Overview

• Status: Recruiting
• Conditions: Implant Complication; Prosthesis and Implants; Peri-Implant Health
• Intervention / Treatment: Device: Pre-fabricated standardized titanium abutments; Device: Customized anatomical zirconia abutments

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.

• Study Type: Interventional
• Enrollment (Estimated): 71
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Leticia Sandoli Arroteia, Ms and PhD Student; Phone Number: +5514981600821; Email: leticia.sandoli@hotmail.com

Study Locations

• Brazil
  • São Paulo
    • Piracicaba, São Paulo, Brazil, 13414903
      • Recruiting
      • Piracicaba Dental School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TiB Group; Participants rehabilitated with pre-fabricated standardized titanium abutments supporting single zirconia crowns. Intervention linked: Pre-fabricated standardized titanium abutments	Device: Pre-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.
Experimental: ZiT Group; Participants rehabilitated with customized anatomical zirconia abutments supporting single zirconia crowns. Intervention linked: Customized anatomical zirconia abutments	Device: Customized 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbial Colonization in Peri-implant Sites	Quantitative assessment of bacterial load in peri-implant crevicular fluid samples, expressed as CFU/ml, determined by qPCR analysis.	1, 3, 6, and 12 months after prosthesis installation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic Characteristics of the Study Population	Descriptive analysis of participant demographic variables, including age and sex, reported as means and frequency distribution.	Baseline

Collaborators and Investigators

• Sponsor: University of Campinas, Brazil
• Investigators: Principal Investigator: Renato Casarin, Associate Professor, University of Campinas, Brazil

Publications and helpful links

General Publications

• Schwarz F, Derks J, Monje A, Wang HL. Peri-implantitis. J Periodontol. 2018 Jun;89 Suppl 1:S267-S290. doi: 10.1002/JPER.16-0350.
• Bouri A Jr, Bissada N, Al-Zahrani MS, Faddoul F, Nouneh I. Width of keratinized gingiva and the health status of the supporting tissues around dental implants. Int J Oral Maxillofac Implants. 2008 Mar-Apr;23(2):323-6. PMID: 18548930.
• Koutouzis T. Implant-abutment connection as contributing factor to peri-implant diseases. Periodontol 2000. 2019 Oct;81(1):152-166. doi: 10.1111/prd.12289.
• Branemark PI, Adell R, Breine U, Hansson BO, Lindstrom J, Ohlsson A. Intra-osseous anchorage of dental prostheses. I. Experimental studies. Scand J Plast Reconstr Surg. 1969;3(2):81-100. doi: 10.3109/02844316909036699. No abstract available.
• Kumar PS. Systemic Risk Factors for the Development of Periimplant Diseases. Implant Dent. 2019 Apr;28(2):115-119. doi: 10.1097/ID.0000000000000873.
• Berglundh, T., Lindhe, J., Ericsson, I., Marinello, C.P., Liljenberg, B. and Thornsen, P. (1991), The soft tissue barrier at implants and teeth. Clinical Oral Implants Research, 2: 81-90. https://doi.org/10.1034/j.1600-0501.1991.020206.x
• Lindhe, J., Meyle, J. and (2008), Peri-implant diseases: Consensus Report of the Sixth European Workshop on Periodontology. Journal of Clinical Periodontology, 35: 282-285. https://doi.org/10.1111/j.1600-051X.2008.01283.x
• Lang, N.P., Berglundh, T. and (2011), Periimplant diseases: where are we now? - Consensus of the Seventh European Workshop on Periodontology. Journal of Clinical Periodontology, 38: 178-181. https://doi.org/10.1111/j.1600-051X.2010.01674.x

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: April 7, 2025
• First Submitted That Met QC Criteria: March 3, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Biofilm; Dental Prosthesis; Dental Porcelain; Connection, Dental Implant-Abutment
• Other Study ID Numbers: 86486425.5.0000.5418

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared due to ethical considerations and privacy concerns, as the data contain sensitive personal health information that could potentially compromise participant confidentiality, even if anonymized. Additionally, no explicit consent for data sharing was obtained from participants during recruitment.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No