Active — Not RecruitingNot Applicable

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

Thailand10 participantsStarted 2024-01-04

Plain-language 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.

Who can participate

Age range20 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Bone gain evaluation

Timeframe: 4 months

Biocompatibility evaluation

Timeframe: 4 months

Trial details

NCT IDNCT06295055

SponsorPrince of Songkla University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-30

View on ClinicalTrials.gov More Guided Bone Regeneration trials