Guided Bone RegenerationSSBSNCT06295055
Semi-rigid Shell Barrier System for Alveolar Bone Augmentation (SSBS for ABA)
A study testing Ridge augmentation with semi-rigid shell barrier system in people with Guided Bone Regeneration and Bone Formation, run by Prince of Songkla University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Guided Bone Regeneration, Bone Formation
- What is being tested?
- Ridge augmentation with semi-rigid shell barrier system
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteThailand
- Study dates
- 4 Jan 2024to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- (i) Heavy smokers (>10 cigarettes/day)
- (ii) receiving bisphosphonates
- (iii) undergoing radiotherapy
- (iv) uncontrolled medical conditions
- (v) Alcoholism
- (vi) Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Guided Bone Regeneration, Bone Formation
- Being tested
- Ridge augmentation with semi-rigid shell barrier system
- Keywords
- Guided bone regeneration, Bone augmentation, Semi-rigid shell, Semi-resorbable membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ridge augmentation with semi-rigid shell barrier systemProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Ridge augmentation with semi-rigid shell barrier system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 months
Secondary outcomes (1)
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start4 Jan 2024
- Primary completion30 Jun 2025
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Guided Bone RegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Before- after augmentation in patients with alveolar bone defects
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prisana Pripatnanont, Prince of Songkla University
- Investigators
- Prisana Pripatnanont, Principal investigator, Dentistry, Prince of Songkhla
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06295055
- Sponsor's protocol ID
- Dentistry Prince of Songkla
- Acronym
- SSBS
- Status last verified
- Sep 2025
- First submitted
- 28 Feb 2024
- Last updated
- 9 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Outcomes of the Semi-rigid Shell Barrier System for Alveolar Bone Augmentation
- ClinicalTrials.gov ID
- NCT06295055
- Acronym / sponsor ID
- SSBS / Dentistry Prince of Songkla
- Conditions
- Guided Bone Regeneration, Bone Formation
- Keywords
- Guided bone regeneration, Bone augmentation, Semi-rigid shell, Semi-resorbable membrane
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- 4 Jan 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 6 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Before- after augmentation in patients with alveolar bone defects
| Arm | Type | Receives |
|---|---|---|
| semi-rigid shell barrier system | Experimental | Procedure: Ridge augmentation with semi-rigid shell barrier systemThe 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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- (i) Heavy smokers (>10 cigarettes/day)
- (ii) receiving bisphosphonates
- (iii) undergoing radiotherapy
- (iv) uncontrolled medical conditions
- (v) Alcoholism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ridge augmentation with semi-rigid shell barrier systemThe 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. | Procedure or surgery | semi-rigid shell barrier system |
Primary outcome
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.
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.
1 secondary outcome
Ridge volume change of alveolar ridge evaluation
Time frame: 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Guided Bone Regeneration
Active, not recruitingObservational study
Long-Term Stability of Soft and Hard Tissues After Guided Bone Regeneration in the Maxillary Anterior Region
Alveolar Bone Deficiency
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Guided Bone Regeneration Using Polydioxanone (PDO) Membrane in Sockets After Tooth Extraction
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Comparison of Three Autogenous Bone and Xenograft Ratios for Horizontal Ridge Augmentation
Horizontal Alveolar Ridge Deficiency
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Alveolar Ridge Preservation (ARP) Study Using Alloplastic Biomaterial and a Resorbable Synthetic Membrane. A Digital Workflow (CBCT/Scanner) Evaluates Hard and Soft Tissue Volumetric Changes at 4 Months, Validating Support for the Gingival Phenotype and Buccal Bone Plate.
Alveolar Ridge Augmentation, Bone Substitutes
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Comparison of Two Autogenous Bone and Xenograft Ratios for Horizontal Ridge Augmentation
Horizontal Alveolar Ridge Deficiency
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prisana Pripatnanont principal investigator
Dentistry, Prince of Songkhla
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ridge augmentation with semi-rigid shell barrier system in people with Guided Bone Regeneration and Bone Formation, run by Prince of Songkla University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone gain evaluation (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.