Comparing soft tissue integration of zirconia and titanium dental implants

Peri-Implant Soft Tissue Integration in Humans: Influence of Material

This study is testing how well soft tissues attach to different types of zirconia dental implants compared to titanium ones to see which works better for patients after surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Hospitalier Universitaire de Liege (Academic / other)
• Locations: 1 site (Liège)
• Trial ID: NCT05805033 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the mucointegration of two types of zirconia abutments with different surface roughness compared to titanium abutments. Participants will be randomly assigned to receive either machined or ultra-polished zirconia abutments during their dental implant surgery. After an 8-week healing period, biopsies will be analyzed to assess the biological width and the adhesion of soft tissues to the abutments. The study will utilize histometric measurements and immunohistochemistry to gather data on tissue integration and inflammatory responses.

Who should consider this trial

Good fit: Ideal candidates include healthy adults aged 18 or older with one or more missing teeth in need of dental implants.

Not a fit: Patients with autoimmune diseases, prolonged steroid use, or active infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the understanding of soft tissue integration with dental implants, leading to better outcomes for patients receiving implant therapy.

How similar studies have performed: While there have been studies on dental implant integration, this specific comparison of zirconia surface roughness is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Participants have to voluntarily sign the informed consent form before any study related action
* Patients aged 18 or over
* Patients with one or more missing teeth in the maxillary or mandible area, seeking implant therapy
* Men/women
* Patients in good systemic health (ASA I/ II) and no contraindication for oral surgical interventions
* Patients requiring a replacement of missing teeth; the tooth at the implant site(s) must have been extracted or lost at least 12 weeks before the date of implantation
* At least 3 mm of fibrous mucosa in the bucco-lingual dimension
* Full mouth plaque score (FMPI) lower than or equal to 25%
* At least a diameter of 4 mm for the implant (regular diameter)

Exclusion Criteria:

* Autoimmune disease requiring medical treatment
* Medical conditions requiring prolonged use of steroids
* Use of Bisphosphonates intravenously or more than 3 years of oral use
* Infection (local or systemic) - patients with gingivitis or active local infection will undergo a medical treatment prior to the entrance to the study, and each individual will be evaluated for suitability; in case of a systemic infection, the evaluation will be based on medical anamneses, and if necessary, a patient will be referred to relevant medical tests
* Current pregnancy or breastfeeding women
* Alcoholism or chronical drug abuse
* Immunocompromised patients
* Uncontrolled diabetes
* Smokers
* Prisoners
* Implant's diameter under 4 mm (narrow implant)
* Conditions or circumstances, in the opinion of the investigator, which would prevent completion of the study or interference with analysis of study results, such as history of non-compliance, or unreliability

Where this trial is running

Liège

• Clémentine Canuel — Liège, Belgium (Recruiting)

Study contacts

• Study coordinator: Clémentine Canuel, MsD

Conditions Healthy Subjects