Semi-rigid Shell Barrier System for Alveolar Bone Augmentation (SSBS for ABA)

Prince of Songkla University

Status: Active, not recruiting

Conditions: Bone Formation; Guided Bone Regeneration

Treatments: Procedure: Ridge augmentation with semi-rigid shell barrier system

Study type: Interventional

Funder types: Other

Identifiers

NCT06295055

Dentistry Prince of Songkla

Details and patient eligibility

About

This study aims to compare the clinical outcome before and after augmentation in case series of 10 patients. The main question it aims to answer is Whether the semi-rigid shell system facilitates bone regeneration in moderate to severe alveolar bone defects after 4 months of bone augmentation. Participants with bone defects between 3 to 8 millimeters (moderate to severe bone defect) will be treated with xenograft covered with the semi-rigid shell barrier system as a stage approach technique for implant placement.

Full description

Inclusion criteria are subjects requiring a bone defect between 3 to 8 millimeters (moderate to severe bone defect) covered 1-2 tooth span with adjacent tooth, planned for dental implant and fixed prosthesis, aged 20 and above but under the age of 65 with good physical health and good oral hygiene, able to comprehend and are willing to sign the consent form and can adhere to the protocol including scheduled clinic visits and assigned treatment and available for follow-up after implant placement.

Exclusion criteria are subjects in following reasons: (i) Heavy smokers (>10 cigarettes/day), (ii) receiving bisphosphonates, (iii) undergoing radiotherapy, (iv) uncontrolled medical conditions, (v) Alcoholism, (vi) Pregnancy Bone augmentation procedure Before surgery, patients will be premedication with 1000 mg of amoxicillin antibiotic and rinse chlorhexidine mouthwash 0.12% concentration for 1 minute. A single oral and maxillofacial surgeon will perform all surgical procedures. Local anesthesia with 4% Articaine hydrochloride with epinephrine 1: 100,000 (Septanest, Septodont, France) will be administered to each patient for inferior alveolar nerve block or local infiltration. A full thickness mucoperiosteal flap will be created, and the actual defect size will be measured with a periodontal probe following the flap procedure. Flap advancement with periosteal releasing flap, decorticate the bone with a round bur, then apply the semi-rigid shell and fix it with ti-tacks or screws. Following that, xenograft, a bone graft material will be placed, and ti-tacks will be used to fix the semi-resorbable covering membrane. Lastly, tension-free flap closure with double layer suturing technique which is a horizontal mattress and interrupts suture.

Enrollment: 10 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• subjects requiring a bone defect between 3 to 8 millimeters (moderate to severe bone defect) covered 1-2 tooth span with adjacent tooth
• Planned for dental implant and fixed prosthesis
• Aged 20 and above but under the age of 65 with good physical health and good oral hygiene
• Able to comprehend and are willing to sign the consent form and can adhere to the protocol including scheduled clinic visits and assigned treatment.
• Available for follow-up after implant placement.

Exclusion criteria

• (i) Heavy smokers (>10 cigarettes/day)
• (ii) receiving bisphosphonates
• (iii) undergoing radiotherapy
• (iv) uncontrolled medical conditions
• (v) Alcoholism
• (vi) Pregnancy.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

semi-rigid shell barrier system

Experimental group

Description:

The semi-rigid shell barrier system is based on polycaprolactone (PCL) and biphasic calcium phosphate (BCP) in a 70:30 ratio. In vitro study, Tunthasen Pripatnanont et al. demonstrated that the semi-rigid shell barrier system exhibits suitable physical characteristics and mechanical properties, including appropriate morphology, hydrophilicity, adequate porosity, and a small pore size of less than 40 µm, facilitating angiogenesis and vascular penetration into the defect area. The semi-rigid shell demonstrates high resistance to compressive force, while the semi-resorbable covering membrane exhibits high elastic strength. In vivo studies have confirmed the effectiveness of the semi-rigid shell barrier system, showing bone and tissue integration after function, good stability, biocompatibility, and property as a barrier due to space-making and maintenance. The system also exhibits limited susceptibility to complications and ease of clinical handling during surgery.

Treatment:

Procedure: Ridge augmentation with semi-rigid shell barrier system