Assessing changes in dental implants in the esthetic zone of the maxilla
Long-term Dimensional Changes in Single Crowns Supported by Short (6 mm) Transmucosal Implants With Divergent or Convergent Neck Profiles in the Esthetic Zone. A Randomized Randomized Controlled Clinical Trial
This study is testing how different types of short dental implants affect the bone and gum health in the front part of the mouth for patients with missing teeth over three years.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 21 Years to 60 Years |
| Sex | All |
| Sponsor | ARDEC Academy Research network |
| Locations | 1 site (Trujillo, La Libertad) |
| Trial ID | NCT06006156 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the long-term changes in bone and soft tissue around short dental implants with either a converging collar with micro threads or a diverging polished collar in partially edentulous patients. Twenty participants will have two implants placed in the esthetic zone of the maxilla, and their clinical and radiographic outcomes will be monitored over a minimum of three years. Key parameters such as plaque index, probing depth, and mucosal margin recession will be assessed at multiple follow-up visits to determine the success rates and dimensional changes of the implants.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 and older with at least two edentulous areas in the esthetic region of the maxilla and sufficient alveolar bone.
Not a fit: Patients with uncontrolled systemic diseases, heavy smokers, or those who have undergone previous bone regeneration procedures in the area of interest may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the outcomes of dental implants in the esthetic zone, leading to better functional and aesthetic results for patients.
How similar studies have performed: While this approach is being evaluated in this trial, similar studies have shown promising results with different implant designs in the past.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Presence of at least two edentulous areas in the esthetic region of the maxilla (from right to left from second premolar to premolar, preferably first premolars and incisors) * Alveolar bone ≥ 8 mm in height and ≥ 5 mm in thickness assessed on CBCT. * Age of ≥ 21 years. * Need for an implant-supported prosthetic restoration. * Be in good general health with no contraindications to oral surgical procedures. * Not be pregnant. * Patients who agree to participate in the study and sign the informed consent. Exclusion Criteria: * The presence of any uncontrolled systemic disease. * History of past or ongoing chemotherapeutic or radiotherapeutic treatments. * Heavy smokers (\>10 cigarettes per day). * Previous bone regeneration procedures in the area of interest
Where this trial is running
Trujillo, La Libertad
- Universidad Nacional de Trujillo — Trujillo, La Libertad, Peru (Recruiting)
Study contacts
- Study coordinator: Daniele Botticelli, PhD
- Email: daniele.botticelli@gmail.com
- Phone: +393339070450
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.