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

NCT07456163 | Recruiting DMC

• 1 other identifier: 86486425.5.0000.5418
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Peri-Implant Health; Implant Complication; Prosthesis and Implants

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Demographic Characteristics of the Study Population

  Baseline

Study Arms (2)

TiB Group

ACTIVE COMPARATOR

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

ZiT Group

EXPERIMENTAL

Participants rehabilitated with customized anatomical zirconia abutments supporting single zirconia crowns. Intervention linked: Customized anatomical zirconia abutments

Device: Customized anatomical zirconia abutments

Interventions

Pre-fabricated standardized titanium abutments DEVICE

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.

TiB Group

Customized anatomical zirconia abutments DEVICE

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.

ZiT Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Campinas, Brazil: lead

Study Sites (1)

Piracicaba Dental School

Piracicaba, São Paulo, 13414903, Brazil

RECRUITING

Related Publications (8)

• 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.

  RESULT

• 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.

  PMID: 31407436 RESULT

• 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.

  PMID: 4924041 RESULT

• Kumar PS. Systemic Risk Factors for the Development of Periimplant Diseases. Implant Dent. 2019 Apr;28(2):115-119. doi: 10.1097/ID.0000000000000873.

  PMID: 30893143 RESULT

• 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

  RESULT

• 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

  RESULT

• 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.

  PMID: 29926957 RESULT

• 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

  RESULT

Study Officials

• Renato Casarin, Associate Professor

  University of Campinas, Brazil

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leticia Sandoli Arroteia, Ms and PhD Student

CONTACT

+5514981600821; leticia.sandoli@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: March 6, 2026
• Study Start: April 30, 2025
• Primary Completion: May 30, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)