Pilot Study on the Effectiveness of a Flexible Hydroxyapatite-Based Composite for Jaw Bone Regeneration
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Bologna
About this trial
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 integration. However, it is necessary to evaluate how well the regenerated bone maintains its structural integrity over time, considering masticatory function and real-life biomechanics. Factors such as mechanical load, remodeling dynamics, and interactions with surrounding tissues could influence the long-term stability of the regenerated bone. Additionally, another important aspect to study is the potential complications and adverse effects associated with the use of the flexible HAp-based composite.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Placement of resorbable HAp-based composite
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov