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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Placement of resorbable HAp-based composite
DeviceThe resorbable HAp-based composite device will be immersed in a saline solution for 15 minutes, allowing it to transition from a rigid state to a flexible and deformable one (Fig. 1). Subsequently, the device will be shaped appropriately on the resin model, ensuring proper placement within the bone defect to be regenerated. Patients will receive antibiotic prophylaxis of 1 g amoxicillin, 1 hour before the procedure (or 300 mg clindamycin in case of penicillin allergy). Before the surgical procedure, patients will rinse with 2% chlorhexidine for one minute to reduce the bacterial load in the oral cavity. For the surgical procedure, under local anesthesia with Articaine and Adrenaline 1:100000, mucoperiosteal flaps will be raised. The pre-shaped resorbable device will then be adapted to the defect and fixed with osteosynthesis screws, used according to clinical practice for this type of intervention. Finally, the flaps will be sutured to ensure primary intention closure.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Treatment with hydroxyapatite-based compositeExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Regenerated Bone Volume
he volume of regenerated bone will be measured using CBCT scans before device placement, immediately after the surgical procedure, and at 8 months post-procedure. The percentage of regenerated bone obtained compared to the initially planned augmentation, i.e., the mean volume difference, will be calculated before the surgical procedure, immediately after device placement, and at 8 months. It is specified that CBCT scans and the procedure are performed as part of routine clinical practice.
Time frame
From the treatment and after 8 months,Secondary outcomes
1
Complications
Any pathological events such as neurological lesions, exposures or infections of the placed medical device, inflammation, fractures or loosening of prosthetic screws, prosthesis fracture, etc., reported in the clinical record and occurring during or after implant placement and throughout the clinical follow-up (m1; m3; m6; m8; and m12 from the surgical placement of the device) will be evaluated as outcomes of intraoperative and postoperative complications.
Time frame
Months 1, 3, 6, 8, and 12.2
Patient Satisfaction
To evaluate the overall satisfaction of patients undergoing the treatment, a validated questionnaire, the Oral Health Impact Profile (OHIP-14), is completed by patients during follow-up visits. The same questionnaire will be administered to patients one month after the surgical procedure and eight months after the procedure. OHIP is a 14-item questionnaire.
Time frame
At 1 month and 9 months after treatment3
Correlation between implant survival and certain systemic and clinical patient factors
The following independent variables will be studied: age, gender, smoking status, jaw in which the implants were placed, type of implant, implant length, implant diameter, and compared with implant survival data (m6, m12, and 3 years)
Time frame
After Treatment for 3 years4
Histological analysis
Histological analysis on samples of regenerated bone collected during the preparation of the implant site, specifically during the passage of the first preparation drill. Paraffin sections will be cut at 4 µm, fixed in formalin, and mounted on slides treated with 3-aminopropyltriethoxysilane. The sections will then undergo immunostaining for blood vessels using antibodies against CD31, VEGF, and KDR epitopes.The criteria established by Weidner and Folkman will be used to identify blood vessels in the immunostained sections. Specifically, positively stained endothelial cells or groups of endothelial cells, regardless of shape and size, that are clearly separated from adjacent blood vessels or other connective tissues, will be counted as blood vessels. Vascular nodules, although usually present, will not be considered a definition of a blood vessel, and red blood cells will not be used to calculate the vascular lumen.
Time frame
8 months after device placement.Sponsors and contacts
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Source ClinicalTrials.gov
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