Pilot Study on the Effectiveness of a Flexible Hydroxyapatite-Based Composite for Jaw Bone Regeneration

NCT06552715 | Not Yet Recruiting Phase 1

• 1 other identifier: PG0091421_2024
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Bone Atrophy; Edentulism; Bone Regeneration

Keywords

bone regeneration; dental implants; jaws atrophy

Outcome Measures

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.

  From the treatment and after 8 months,

Secondary Outcomes (8)

• Complications

  Months 1, 3, 6, 8, and 12.

• Patient Satisfaction

  At 1 month and 9 months after treatment

• Correlation between implant survival and certain systemic and clinical patient factors

  After Treatment for 3 years

• Histological analysis

  8 months after device placement.

• Hard Tissues Conditions

  At months: 3, 6, 12 and 3 years after treatment

Study Arms (1)

Treatment with hydroxyapatite-based composite

EXPERIMENTAL

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. Patients must be 18 years or older and must provide informed consent.

Device: Placement of resorbable HAp-based composite

Interventions

Placement of resorbable HAp-based composite DEVICE

The 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 with hydroxyapatite-based composite

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Bologna: lead

Study Sites (1)

Dental Clinic, Unit of Oral Surgery, University of Bologna

Bologna, 40125, Italy

Location

Central Study Contacts

Pietro Felice, MD, DDS, PhD

CONTACT

+39 0512088157; pietro.felice@unibo.it

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Pietro Felice

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 14, 2024
• Study Start: September 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: September 1, 2025
• Last Updated: August 14, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: From September 2025
• Access Criteria: Access credentials to journal resources

Locations

IT (1)