Zirconia versus titanium abutments for single posterior implant restorations
Potential Influence of Pre-fabricated and Customized Anatomical Zirconia Abutments in the Peri-implant Region for Single-tooth Implant-supported Prosthetic Restorations
This study will test whether customized zirconia abutments or standard titanium abutments better protect the tissues, limit bone loss, and improve oral quality of life for adults receiving a single posterior implant crown.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 71 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of Campinas, Brazil Academic / other |
| Locations | 1 site (Piracicaba, São Paulo) |
| Trial ID | NCT07456163 on ClinicalTrials.gov |
What this trial studies
This randomized controlled clinical trial compares prefabricated titanium abutments with customized milled zirconia abutments in adults receiving single implant-supported posterior zirconia crowns after prior alveolar preservation and implant placement. After implant osseointegration, eligible participants from the earlier alveolar-preservation trial are randomly assigned 1:1 to receive either the standardized titanium abutment (TiB) or the customized anatomical zirconia abutment (ZiT), with all prosthetic and laboratory procedures standardized. Clinical and radiographic assessments target peri-implant soft tissues, implant biocompatibility, bone-level changes, and oral-health related quality of life at prosthesis delivery (baseline) and scheduled follow-up visits. Sample size was calculated with GPower and allocation is computer-generated to ensure adequate statistical power and concealment.
Who should consider this trial
Good fit: Ideal candidates are adults from the prior alveolar-preservation study who have healed, osseointegrated posterior implants without surrounding bone loss and can attend prosthetic visits at Piracicaba Dental School.
Not a fit: Patients with uncontrolled systemic disease, current or former smokers, pregnant or lactating women, those on medications that interfere with bone healing, or implants with existing bone loss are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, customized zirconia abutments could reduce soft-tissue inflammation and radiographic bone loss while improving comfort and appearance around single posterior implants.
How similar studies have performed: Previous laboratory and clinical studies have suggested zirconia abutments may give favorable soft-tissue responses and aesthetics versus titanium, but long-term randomized clinical evidence is still limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Piracicaba, São Paulo
- Piracicaba Dental School — Piracicaba, São Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: Renato Casarin, Associate Professor — University of Campinas, Brazil
- Study coordinator: Leticia Sandoli Arroteia, Ms and PhD Student
- Email: leticia.sandoli@hotmail.com
- Phone: +5514981600821
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.