NCT07500961

Novel Bone Substitute (ALBO-OS) in Patients With Periodontal Disease or Who Need Alveolar Preservation

The First/Second Stage of Open Clinical Examination: Application of Novel Bone Substitute (ALBO-OS) in Patients With Periodontal Disease or Have a Need for Alveolar Preservation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Albos d.o.o. Beograd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The recent Global Burden of Disease Study indicates that severe periodontitis is the 6th most prevalent disease worldwide, with an overall prevalence of 11.2% and around 743 million people affected, and the global burden of periodontal disease increased by 57.3% from 1990 to 2010. As periodontitis is the major cause of tooth loss in the adult population worldwide, these individuals are at risk of multiple tooth loss, edentulism, and masticatory dysfunction, thereby affecting their nutrition, quality of life, and self-esteem, as well as imposing huge socioeconomic impacts and healthcare costs. The global burden of periodontal diseases remains high, and trends in risk factors, improved tooth retention, and an aging population are likely to bear further increases. Associated morbidity, costs, and socio-economic impact will continue to rise. In addition to the need to treat more severe forms of periodontitis by implanting bone substitutes inside periodontal pockets, there are extremely frequent requests to preserve the alveolus after tooth extraction. Alveolar ridge preservation is a popular technique, currently accounting for about 29% of all procedures involving bone substitutes. Application of this technique is necessary if the subsequent installation of dental implants based on titanium alloys is planned. The prevalence of this technique in dental medicine is also indicated by the fact that the global cost of bone replacement materials for the preservation of the alveolar ridge is estimated at 190 million dollars per year, with an expected annual growth of approximately 11.4%. The implantation of the ALBO-OS for the treatment of periodontal pockets with probing depth more than 5mm and alveolar ridge augmentation is considered an essential method for significant improvement of oral health for patients with advanced periodontitis. Following the main requirements for an ideal bone substitute for filling the periodontal pockets and alveolar sockets, such as its high porosity, satisfactory chemistry and surface topography characteristics, as well as desirable microstructure and mechanical properties, ALBO-OS shows numerous advantages compared with recently developed used bone grafts, particularly expressed in their excellent osteoconductive and osteoinductive properties, have been approved on a wide scale of animal assays. Therefore, it will be applied in clinical trials for the healing of severe periodontitis disease when implantation of the bone substitute is required. Financial support of the study is provided by the sponsor's consortium, with ALBOS Ltd as the main sponsor. The recruitment site is the Home Health, Foča, Republic of Srpska, Bosnia and Herzegovina.

Conditions

• Periodontitis

Interventions

Type	Name	Description
DEVICE	Albo Os	ALBO-OS is a bone substitute designed to fulfill the principal requirements of an ideal graft material for periodontal pocket filling, including high porosity, optimal surface chemistry and topography, and desirable microstructural and mechanical properties. ALBO-OS demonstrates notable advantages over currently available bone graft materials, particularly with respect to its osteoconductive and osteoinductive properties, which have been validated across a broad range of animal model studies.

Timeline

• Start date: 2024-03-01
• Primary completion: 2025-03-01
• Completion: 2026-02-26
• First posted: 2026-03-30
• Last updated: 2026-03-30

Locations

1 site across 1 country: Bosnia and Herzegovina