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NCT Number: NCT06295055

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Guided Bone Regeneration Bone Formation

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prince of Songkla

Songkhla, Hatyai, 90110, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Bone gain evaluation

    Time frame: 4 months

    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.

  2. Biocompatibility evaluation

    Time frame: 4 months

    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.

Secondary outcomes

  1. Ridge volume change of alveolar ridge evaluation

    Time frame: 4 months

    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.

Sponsors and collaborators

Lead sponsor

Prince of Songkla University

Other

Registry information

Official study title

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

Acronym: SSBS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 6, 2024
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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