Clinical trial NCT06295055: Semi-rigid Shell Barrier System for Alveolar Bone Augmentation (SSBS for ABA)
Official title: Evaluation of Clinical Outcomes of the Semi-rigid Shell Barrier System for Alveolar Bone Augmentation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Guided Bone Regeneration
Bone Formation
Bone Volume
Keywords: Guided bone regeneration
Bone augmentation
Semi-rigid shell
Semi-resorbable membrane
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2024-03-06
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Before- after augmentation in patients with alveolar bone defects
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Bone gain evaluation
timeFrame: 4 months
measure: Biocompatibility evaluation
timeFrame: 4 months
Secondary outcomes:
measure: Ridge volume change of alveolar ridge evaluation
timeFrame: 4 months
Other outcomes:
Locations:
city: Songkhla
country: Thailand
facility: Prince of Songkla
state: Hatyai
Study officials:
affiliation: Dentistry, Prince of Songkhla
name: Prisana Pripatnanont
role: PRINCIPAL_INVESTIGATOR
References: