Status:
NOT_YET_RECRUITING
Pilot Study on the Effectiveness of a Flexible Hydroxyapatite-Based Composite for Jaw Bone Regeneration
Lead Sponsor:
University of Bologna
Conditions:
Bone Atrophy
Edentulism
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Following a review of the scientific literature, it was found that there are no clinical studies but only in vitro and in vivo studies, which show promising results in terms of bone formation and inte...
Detailed Description
Following a review of the scientific literature, it was found that there are no clinical studies but only in vitro and in vivo studies, which show promising results in terms of bone formation and inte...
Eligibility Criteria
Inclusion
- Patients with partially edentulous and atrophic jaws, requiring implant-prosthetic rehabilitation (from 1 to 3 implants), classified as Seibert Class II or III, and needing a GBR bone regeneration intervention with defects not exceeding 7 mm in height
- Age 18 years or older
- Obtaining informed consent
Exclusion
- Patients who have received radiation therapy to the head and neck with more than 70 Gray.
- Immunocompromised and immunosuppressed patients.
- Patients treated with or currently receiving intravenous amino-bisphosphonates.
- Patients with poor oral hygiene and lack of motivation.
- Uncontrolled diabetes.
- Pregnancy or breastfeeding.
- Drug or alcohol dependence.
- Psychiatric conditions that contraindicate surgical treatment.
- Limited mouth opening (less than 3.5 cm distance between the two arches in the anterior area).
- Patients with acute or chronic inflammation/infection at the implant site.
- Patients referred solely for implant placement.
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06552715
Start Date
September 1 2024
End Date
September 1 2025
Last Update
August 14 2024
Active Locations (1)
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1
Dental Clinic, Unit of Oral Surgery, University of Bologna
Bologna, Italy, 40125