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

Evaluation of Clinical Outcomes of the Semi-rigid Shell Barrier System for Alveolar Bone Augmentation

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.

Study Overview

• Status: Recruiting
• Conditions: Guided Bone Regeneration; Bone Formation; Bone Volume
• Intervention / Treatment: Procedure: Ridge augmentation with semi-rigid shell barrier system

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Prisana Pripatnanont; Phone Number: 0813686306; Email: prisana.p@psu.ac.th
• Study Contact Backup: Name: panisa tantiwongs; Phone Number: 0824864497; Email: k-kampt@hotmail.com

Study Locations

• Thailand
  • Hatyai
    • Songkhla, Hatyai, Thailand, 90110
      • Recruiting
      • Prince of Songkla
      • Contact: panisa tantiwongs; Phone Number: 0824864497; Email: k-kampt@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: semi-rigid shell barrier system; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ridge volume change of alveolar ridge evaluation	The study will measure and analyze the volume change of the buccal alveolar ridge at baseline, 1 month, and 4 months after a bone augmentation procedure. The images will be obtained using an intraoral scanner and exported as stereolithography (STL) files. To minimize image distortion, matching and superimposition of 3D models of preoperative and postoperative bone defects will be conducted. The analysis of the data will be done using Geomagic Studio 1 software.The region of interest will be designated 10 mm. below the bone peak of adjacent teeth, and the volume of soft tissue in the targeted area will be calculated. The clinical ridge volume of bone defects will be measured in cubic mm. (mm.3) using a volumetric analysis tool.	4 months

Collaborators and Investigators

• Sponsor: Prince of Songkla University
• Investigators: Principal Investigator: Prisana Pripatnanont, Dentistry, Prince of Songkhla

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2024
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: February 28, 2024
• First Submitted That Met QC Criteria: February 28, 2024
• First Posted (Estimated): March 6, 2024

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Guided bone regeneration; Bone augmentation; Semi-rigid shell; Semi-resorbable membrane
• Other Study ID Numbers: Dentistry Prince of Songkla

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No