Comparing tissue-level and bone-level dental implants

Sopravvivenza e Healing Rate di Due Tecniche di Otturazione Canalare: Studio Clinico Randomizzato

This study is testing whether tissue-level dental implants work better than traditional bone-level implants for improving the health of the surrounding gum tissue in people getting dental implants.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: University of Bologna (other)
• Locations: 1 site (Bologna)
• Trial ID: NCT06252324 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of tissue-level surgical techniques for dental implants compared to traditional bone-level techniques. Conducted at the University of Bologna, the study will randomly assign participants to receive either type of implant, with a focus on assessing changes in peri-implant tissues. The trial will involve 80 participants, with 40 receiving tissue-level implants and 40 receiving bone-level implants, over a recruitment period of approximately 12-15 months. All procedures will adhere to international guidelines to ensure ethical standards are met.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 who require a single-tooth implant and have sufficient bone volume for placement.

Not a fit: Patients with significant medical contraindications, poor oral hygiene, or those who smoke more than 10 cigarettes per day may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved outcomes for patients receiving dental implants, particularly in terms of tissue health and integration.

How similar studies have performed: While there have been studies on dental implants, this specific comparison of tissue-level versus bone-level techniques is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Age between 18-75 years;
* Healthy or with mild functional limitations according to ASA classification 1-2 (16);
* Consumption of fewer than 10 cigarettes per day;
* Need for implant rehabilitation in a single-tooth edentulous area;
* Presence of adequate volumes of bone tissue (3.5mm thickness and 9mm height) to allow proper implant placement and optimal primary stability.

Exclusion Criteria:

* Age under 18 years;
* Medical and/or general contraindications to surgical procedures (ASA score ≥3) (16);
* Poor oral hygiene and lack of motivation and/or active clinical periodontal disease expressed by probing pocket depth \>4 mm and bleeding on probing;
* Smoking more than 10 cigarettes per day;
* Systemic or local diseases that could compromise post-operative healing and osseointegration;
* Alcohol and/or drug abuse;
* Pregnancy or breastfeeding;
* Malocclusion and other occlusal disorders;
* Bisphosphonate therapy.

Where this trial is running

Bologna

• Endodontic clinical section, DIBINEM, UNiversity of Bologna — Bologna, Italy (RECRUITING)

Study contacts

• Principal investigator: Maria Giovanna Gandolfi — Dibinem, University of Bologna
• Study coordinator: Carlo Prati

Conditions: Bone Loss