Evaluation of Customized Allograft Bone Blocks for Dental Rehabilitation
Histological and Volumetric Evaluation of Customized Allograft Bone Blocks in Severe Atrophy of the Mandible: a Prospective Cohort Clinical Trial
NA · Universitat Internacional de Catalunya · NCT05937035
This study tests if specially designed bone blocks can help people with jaw issues heal better and successfully get dental implants.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitat Internacional de Catalunya (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Sant Cugat Del Vallès, Barcelona) |
| Trial ID | NCT05937035 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of customized allograft bone blocks designed using CBCT and digital software for rehabilitating the posterior mandible. The primary objective is to assess bone regeneration through histological analysis and volumetric changes of the allograft. Additionally, the study aims to determine the success rate of dental implants placed in the regenerated area. The procedure involves creating a precise fit of the bone block to the defect and securing it with screws and membranes to promote healing.
Who should consider this trial
Good fit: Ideal candidates are healthy adults requiring rehabilitation of the posterior mandible with at least two dental implants.
Not a fit: Patients with acute infections, untreated periodontal disease, or medical conditions contraindicating implant surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved bone regeneration and reduced complications in dental implant procedures.
How similar studies have performed: While the use of allografts is established, the specific approach of customized bone blocks using advanced imaging and design is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Signed informed consent 2. Overall, healthy subjects (ASA1 and 2) 3. Females and males of at least eighteen-years 4. Requiring a posterior mandible rehabilitation with a minimum of 2 dental implants 5. Able to follow instructions and attend a regular compliance Exclusion Criteria: 1. Acute local infection 2. Untreated periodontal disease assessed by Socransky et al. parameters (≥ 2mm clinical attachment loss in two consecutive visits within 1 year) 3. Drug and/or alcoholic dependencies 4. Medical conditions contraindicating implant surgery 5. History of head and/or neck radiation 6. Bisphosphonate therapy
Where this trial is running
Sant Cugat Del Vallès, Barcelona
- Universitat Internacional de Catalunya — Sant Cugat Del Vallès, Barcelona, Spain (RECRUITING)
Study contacts
- Principal investigator: JORDI GARGALLO-ALBIOL — Universitat Internacional de Catalunya
- Study coordinator: JAVIER GAMON VIDAL
- Email: jgamon@uic.es
- Phone: +34627321249
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: Alveolar Bone Resorption, Graft Overgrowth, Resorption of Bone Graft, Graft Complication, Block