Using a semi-rigid shell to improve bone regeneration for dental implants
Evaluation of Clinical Outcomes of the Semi-rigid Shell Barrier System for Alveolar Bone Augmentation
This study is testing if a special shell can help people with bone loss in their jaw grow new bone for dental implants.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 20 Years to 65 Years |
| Sex | All |
| Sponsor | Prince of Songkla University Academic / other |
| Locations | 1 site (Songkhla, Hatyai) |
| Trial ID | NCT06295055 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a semi-rigid shell barrier system in facilitating bone regeneration in patients with moderate to severe alveolar bone defects. It involves a case series of 10 patients who will undergo bone augmentation using a xenograft covered by the semi-rigid shell. The primary goal is to assess clinical outcomes after a 4-month period post-augmentation, focusing on patients aged 20 to 65 who are in good health and have good oral hygiene. The surgical procedures will be performed by a single oral and maxillofacial surgeon under local anesthesia.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 to 65 with moderate to severe alveolar bone defects requiring augmentation for dental implants.
Not a fit: Patients who are heavy smokers, have uncontrolled medical conditions, or are undergoing treatments like bisphosphonates or radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance bone regeneration and improve outcomes for patients needing dental implants.
How similar studies have performed: While the specific semi-rigid shell approach may be novel, similar techniques in guided bone regeneration have shown promise in previous studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Songkhla, Hatyai
- Prince of Songkla — Songkhla, Hatyai, Thailand (Recruiting)
Study contacts
- Principal investigator: Prisana Pripatnanont — Dentistry, Prince of Songkhla
- Study coordinator: Prisana Pripatnanont
- Email: prisana.p@psu.ac.th
- Phone: 0813686306
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.