NCT07456163 Influence of Zirconia Abutments on Peri-Implant Tissues in Single-Tooth Restorations
| NCT ID | NCT07456163 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Campinas, Brazil |
| Condition | Peri-Implant Health |
| Study Type | INTERVENTIONAL |
| Enrollment | 71 participants |
| Start Date | 2025-04-30 |
| Primary Completion | 2026-05-30 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 71 participants in total. It began in 2025-04-30 with a primary completion date of 2026-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Renato Casarin, Associate Professor
PRINCIPAL INVESTIGATOR
University of Campinas, Brazil
Frequently Asked Questions
Who can join the NCT07456163 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Peri-Implant Health. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07456163 currently recruiting?
Yes, NCT07456163 is actively recruiting participants. Contact the research team at leticia.sandoli@hotmail.com for enrollment information.
Where is the NCT07456163 trial being conducted?
This trial is being conducted at Piracicaba, Brazil.
Who is sponsoring the NCT07456163 clinical trial?
NCT07456163 is sponsored by University of Campinas, Brazil. The principal investigator is Renato Casarin, Associate Professor at University of Campinas, Brazil. The trial plans to enroll 71 participants.