Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
Healthy Volunteers
ID07456163

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

Led by University of Campinas, Brazil · Updated on 2026-03-17

71

Participants Needed

1

Research Sites

78 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of two types of abutments—pre-fabricated standardized titanium and customized anatomical zirconia—on the health of tissues around single implant-supported posterior teeth. This randomized controlled clinical trial focuses on how these abutments impact implant biocompatibility, peri-implant tissue stability, bone loss seen on X-rays, and the quality of life related to oral health. The study builds upon a previous phase where participants had tooth extractions, alveolar preservation, and implant placement with a six-month healing period. Participants who have successfully integrated implants will be randomly assigned to receive prosthetic rehabilitation with either titanium abutments or zirconia abutments, both supporting single zirconia crowns in back teeth. The prosthetic and lab procedures follow standardized digital protocols. The study includes follow-up visits at prosthesis delivery and 1, 3, 6, and 12 months afterward to monitor changes and responses. During the study, researchers will collect samples of peri-implant crevicular fluid and biofilm for biomolecular analysis and measure periodontal health, mucosa thickness, and bone levels using standardized X-rays. Digital scans will assess soft tissue volume and stability. The main outcome is microbial colonization at the implant sites over 12 months. Secondary outcomes include demographic data, clinical parameters, bone level changes, and soft tissue stability. This research aims to improve understanding of how abutment materials influence long-term implant health.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Individuals aged 18 years or older and up to 70 years
  • Participants from the Master's Thesis study on alveolar preservation in posterior regions
  • Patients with implants and healing abutments from Bionnovation Biomedical at prosthetic rehabilitation
  • Implants must show no surrounding bone loss
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • Patients with uncontrolled systemic diseases
  • Pregnant or lactating women
  • Smokers or former smokers
  • Patients undergoing orthodontic treatment
  • Use of medications interfering with bone healing, such as osteoporosis drugs and bisphosphonates
  • Implants with bone loss or failed implants

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit

Implementation

Duration - 1 day

Participants receive prosthetic rehabilitation with either pre-fabricated standardized titanium abutments or customized anatomical zirconia abutments connected to previously placed implants, followed by installation of single zirconia crowns using standardized digital prosthetic procedures.

1 visit (in-person) for abutment placement and crown installation

Follow-up

Duration - 12 months

Participants undergo clinical and laboratory assessments at prosthesis delivery and at 1, 3, 6, and 12 months to evaluate peri-implant tissue stability, biological response, and soft tissue dimensional changes.

5 visits (in-person) including baseline and follow-up assessments at 1, 3, 6, and 12 months

Trial Site Locations

Total: 1 location

1

Piracicaba Dental School

Piracicaba, São Paulo, Brazil, 13414903

Actively Recruiting

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Research Team

L

Leticia Sandoli Arroteia, Ms and PhD Student

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Peri-implant diseases: Consensus Report of the Sixth European Workshop on Periodontology.

Jan Lindhe, Joerg Meyle, Group D of European Workshop on Periodontology

https://pubmed.ncbi.nlm.nih.gov/18724855

Periimplant diseases: where are we now?--Consensus of the Seventh European Workshop on Periodontology.

Niklaus P Lang, Tord Berglundh, Working Group 4 of Seventh European Workshop on Periodontology

https://pubmed.ncbi.nlm.nih.gov/21323713