Evaluating dental implants with or without collagen matrix augmentation
Clinical Outcomes of Immediate Implants With or Without a Volume-stable Collagen Matrix: a Randomized Controlled Clinical Trial
NA · University of Pisa · NCT05081284
This study is testing whether adding a collagen matrix around dental implants placed right after tooth extraction helps improve the healing of the surrounding soft tissue compared to implants without the matrix.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pisa (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Pisa) |
| Trial ID | NCT05081284 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the clinical outcomes of soft tissue around dental implants placed immediately after tooth extraction, comparing two groups: one receiving a volume-stable collagen matrix augmentation and the other receiving only the implant. Participants will be screened for eligibility and randomized into either the test group, which receives the collagen matrix, or the control group, which does not. The study will focus on the soft tissue clinical results to determine the effectiveness of the collagen matrix in enhancing outcomes post-implantation.
Who should consider this trial
Good fit: Ideal candidates are individuals with a single failing tooth in the esthetic region who do not have any systemic conditions affecting healing.
Not a fit: Patients who are heavy smokers, have uncontrolled periodontal disease, or other contraindications to implant surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the aesthetic and functional outcomes of dental implants for patients undergoing tooth extraction.
How similar studies have performed: Previous studies have shown promising results with collagen matrix augmentation in dental implant procedures, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: - Presence of a single failing tooth in the esthetic region (second premolar to contralateral second premolar), the adjacent teeth should be present and without any dental pathologies. Exclusion Criteria: * Patients who are heavy smokers (more than 10 cigarettes/day); * Patients who suffer from any systemic diseases that could negatively influence wound healing; * Patients who received head and neck radiation treatment; * Patients who have a full contraindication to implant surgery; * Patients who have uncontrolled periodontal disease; * Patients who show a full mouth plaque and bleeding score higher than 25%; * Patients who have deficient extraction sockets according to the classification of Juodzbalys et al. 2008. * Patients with known allergy, sensitivity or intolerance to collagen * Patients who are pregnant or who are breastfeeding
Where this trial is running
Pisa
- U.O. Odontostomatologia e Chirurgia del Cavo Orale — Pisa, Italy (RECRUITING)
Study contacts
- Principal investigator: Antonio Barone, DDS — University of Pisa
- Study coordinator: Antonio Barone, DDS
- Email: antonio.barone@unipi.it
- Phone: 050993327
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.
Conditions: Edentulous Alveolar Ridge, Soft tissue augmentation, Immediate implant, Collagen matrix