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

Guided Bone Regeneration Clinical Trial

— SSBS for ABA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06295055
• Other study ID #: Dentistry Prince of Songkla
• Status: Recruiting
• Phase: N/A
• Start date: January 4, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: February 2024
• Source: Prince of Songkla University
• Contact: Prisana Pripatnanont
• Phone: 0813686306
• Email: prisana.p[@]psu.ac.th
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 30, 2025
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Guided Bone Regeneration

Intervention

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.

Locations

Country	Name	City	State
Thailand	Prince of Songkla	Songkhla	Hatyai

Sponsors (1)

Lead Sponsor	Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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