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

NCT06295055 | Active Not Recruiting

• 1 other identifier: Dentistry Prince of Songkla
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Guided Bone Regeneration; Bone Formation

Keywords

Guided bone regeneration; Bone augmentation; Semi-rigid shell; Semi-resorbable membrane

Outcome Measures

Primary Outcomes (2)

• Bone gain evaluation

  CBCT images will be taken of the alveolar bone defect with an acrylic stent before the operation as a baseline, immediately post-operative, and 4 months after the operation. The most obvious point of the marker will be used to determine the vertical and horizontal bone gain.The distances from the reference points to the alveolar bone defect will be measured using analysis software.Any changes in the distances between the time points will be calculated in percentages.

  4 months

• Biocompatibility evaluation

  The semi-resorbable covering membrane and the semi-rigid shell will be removed during the re-entry visit, and a trephine bone in size of 2x4 mm. will be analyzed using standard histology. The specimen will be fixed with 10% formalin, then the specimens will be embedded in paraffin, and longitudinal serial 5 μm-thick sections will be cut through their midline and stained with Hematoxylin and Eosin (H\&E). The section slides will be scanned using a slide scanner (ScanScope, Aperio, USA) to create image files. The histological features of the specimens will be evaluated descriptively.

  4 months

Secondary Outcomes (1)

• Ridge volume change of alveolar ridge evaluation

  4 months

Study Arms (1)

semi-rigid shell barrier system

EXPERIMENTAL

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.

Procedure: Ridge augmentation with semi-rigid shell barrier system

Interventions

Ridge augmentation with semi-rigid shell barrier system PROCEDURE

The semi-rigid shell, fixed to the outside cortex by tacks, acts as a bone wall. Bone particles are placed in the gap and covered with the semi-resorbable covering membrane, serving as a barrier membrane.

semi-rigid shell barrier system

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Prince of Songkla University: lead

Study Sites (1)

Prince of Songkla

Songkhla, Hatyai, 90110, Thailand

Location

Study Officials

• Prisana Pripatnanont

  Dentistry, Prince of Songkhla

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Before- after augmentation in patients with alveolar bone defects

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 6, 2024
• Study Start: January 4, 2024
• Primary Completion: June 30, 2025
• Study Completion: October 31, 2025
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)