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

NCT07500961 | Completed

• 1 other identifier: ALMBIH CT ID 08-07.5-1754-3/23
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (11)

• Healing of periodontal pockets or alveolar sockets without any known adverse events

  Monitoring and reporting AE and SAE

  12 months

• Formation and osseointegration of the new bone tissue inside periodontal pockets with an initial periodontal probing depth of more than 5 mm, caused by the implantation of the new bone substitute, explained by PPD

  Reduction of the depth of periodontal pockets: Reduction of the initial periodontal probing depth (PPD) ≥ 5 mm, caused by formation of the new bone tissue inside periodontal pockets, determined by CBCT, comparing their dimensions before implantation and 6 months after implantation of bone substitute, in mm.

  6 months

• Formation and osseointegration of the new bone tissue inside periodontal pockets with initial periodontal probing depth more than 5 mm, caused by the implantation of the new bone substitute, explained by CAL

  Reduction of the depth of periodontal pockets: Changes from baseline clinical attachment level (CAL) measured by CBCT as a distance from the cementoenamel junction (CEJ) to the bottom of the periodontal pocket (PD) before implantation and 6 months after implantation of bone substitute, in mm.

  6 months

• Healing bone tissue inside periodontal pockets with an initial periodontal probing depth of more than 5 mm, caused by the implantation of the new bone substitute, explained by GI

  Gingival index (GI) is a numerical index for determining the level of gingival inflammation. LoeSilness was used as a numerical index to determine the level of gingival inflammation following the Gingival Index criteria: 0: Normal gingiva 1. Mild inflammation (slight color change and edema, but no bleeding on probing) 2. Moderate inflammation (redness, edema, glazing, and bleeding on probing) 3. Severe inflammation (marked redness and edema, ulceration, and tendency to spontaneous bleeding. In this study, GI before treatment had a value between 1 and 2.16 (mild to moderate inflammation), while after treatment these values were 0-1 (normal gingiva or slightly inflamed).

  6 months

• Healing bone tissue inside periodontal pockets with an initial probing depth of more than 5 mm, caused by the implantation of the new bone substitute, explained by PI

  Plaque index (PI) is a numerical index for determining the level of oral hygiene. SilnessLoe prices are given as follows: 0 - No plaque 1. \- Plaque adhering to the gingival margin and adjacent area of the tooth. The plaque can be seen in situ only after application of a disclosing solution or by using the probe on the tooth surface. 2. \- Moderate accumulation of soft deposit within the gingival pockets, or the tooth and the gingival margin, which can be seen with the naked eye. 3. \- Abundance of soft matter within the gingival pockets (PI index was calculated by using formula: PI=Ʃ Scores for plaque/4 surfaces x number of teeth). In this study, PI had been valued the most frequently between 0.6 and 1, with one extreme for one patient of 1.72. After treatment in the whole, these values were less than 0.5. No plaque or plaque being slightly visible only after application of disclosing solution or by using the probe on the tooth surface

  6 months

• Healing bone tissue inside periodontal pockets with an initial probing depth of more than 5 mm, explained by MMI

  The Miller mobility index (MMI) is a numerical index for determining the mobility of the tooth. It assesses the horizontal and vertical movement of a tooth within its socket to determine periodontal health. Grade 0: Physiological mobility, undetectable/normal (up to 0.2) Grade 1: Slight mobility (horizontal movement between (0.2-1mm) Grade 2: Moderate mobility (horizontal movement \> 1mm) Grade 3: Severe mobility (horizontal movement \>1 mm and vertical displacement (depressible)). In this study, the Miller mobility index was grade 0 in all cases.

  6 months

• Augmentation of the alveolar ridge, explained by ABV

  Alveolar bone width (ABV), which is the distance between the highest point on the vestibular cortical bone and the highest coronal point on the palatal cortical bone, determined by CBCT, comparing these dimensions before implantation and 4 months after implantation of bone substitute, in mm.

  4 months

• Augmentation of the alveolar ridge, explained by ABH

  Alveolar bone height (ABH), which is measured as the distance between the highest point on the vestibular cortical bone and the cortical bone of the maxillary sinus, determined by CBCT, comparing these dimensions before implantation and 4 months after implantation of bone substitute, in mm.

  4 months

• Healing bone tissue inside alveolar sockets, explained by GI

  Gingival index (GI) is a numerical index for determining the level of gingival inflammation. LoeSilness was used as a numerical index to determine the level of gingival inflammation following the Gingival Index criteria: 0: Normal gingiva 1: Mild inflammation (slight color change and edema, but no bleeding on probing) 2: Moderate inflammation (redness, edema, glazing, and bleeding on probing) 3: Severe inflammation (marked redness and edema, ulceration, and tendency to spontaneous bleeding. GI before implantation for all patients was 0.6-2 (mild to moderate inflammation), and 4 months after implantation, 0-0.37 (normal or slightly mild inflammation).

  4 months

• Healing bone tissue inside alveolar sockets, explained by PI

  Plaque index (PI) is a numerical index for determining the level of oral hygiene. SilnessLoe prices are given as follows: 0 - No plaque 1. \- Plaque adhering to the gingival margin and adjacent area of the tooth. The plaque can be seen in situ only after application of a disclosing solution or by using the probe on the tooth surface. 2. \- Moderate accumulation of soft deposit within the gingival pockets, or the tooth and the gingival margin, which can be seen with the naked eye. 3. \- Abundance of soft matter within the gingival pockets (PI index was calculated by using the formula: PI=Ʃ Scores for plaque/4 surfaces x number of teeth). GI before implantation for all patients was 0.61-1.15 (mild to moderate inflammation), and 4 months after implantation, 0-0.41 (normal or slightly plaque adhering or gingival margin).

  4 months

• Healing bone tissue inside alveolar sockets, explaned by MMI

  The Miller mobility index (MMI) is a numerical index for determining the mobility of the tooth. It assesses the horizontal and vertical movement of a tooth within its socket to determine periodontal health. Grade 0: Physiological mobility, undetectable/normal (up to 0.2) Grade 1: Slight mobility (horizontal movement between (0.2-1mm) Grade 2: Moderate mobility (horizontal movement \> 1mm) Grade 3: Severe mobility (horizontal movement \>1 mm and vertical displacement (depressible)). In this study, the Miller mobility index was grade 0 in all cases.

  4 months

Study Arms (1)

Albo Os group

EXPERIMENTAL

Device: Albo Os

Interventions

Albo Os DEVICE

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.

Albo Os group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent has been signed
• Age 18 years and above
• Stable dose of current regular medication (specify type if needed) for at least 4 weeks before trial entry
• Acceptable laboratory analysis
• No systemic diseases which could influence the outcome of the therapy, or interfere in any way with treatment outcomes, such as they are: an acute or chronic infection (e.g., osteomyelitis) at the site of implantation, uncontrolled metabolic diseases such as diabetes, osteomalacia, disorders of the thyroid gland, or heavy disturbances in the liver or kidney
• Good compliance with individual plaque control following initial periodontal therapy
• Teeth to be involved should be vital (intact or with fillings but without the presence of caries lesion) with score 0 mobility
• The selected 2- or 3-wall intrabony defect depth, which ranges from 3-5 mm, as detected in diagnostic Panoramic Radiograph and clinical examination
• Selected pocket depth (PD) ≥ 5 mm and clinical attachment level (CAL) ≥ 3 mm at the site of the endosseous defect
• Angle radiographic bone defect ≤55 and ≥15
• The availability of program monitoring and maintenance of oral hygiene
• No history of periodontal therapy in the previous 6 months
• No history of antibiotics' intake or other medications affecting the periodontium in the previous 3 months
• Minimum number of teeth is 16 (50% of all teeth/mouth) to achieve a desirable treatment effect
• To preserve the dimensions of the bone of the alveolar ridge, in the indication of alveolus preservation, immediately after previous tooth extraction, in the case of planned installation of implants based on titanium alloys, it is necessary to preserve the alveolus for at least two months before implant installation

You may not qualify if:

• Pregnancy and lactation 6 months before the study and during the study
• Significant renal or hepatic impairment
• Scheduled elective surgery or other procedures requiring general anesthesia or local (oral) surgery during the trial
• Subject with a life expectancy of less than 6 months
• Periodontal treatment for the previous year
• Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
• Participation in another research trial involving an investigational product of a similar type in the past 12 weeks

Sponsors & Collaborators

• Albos d.o.o. Beograd: lead

Study Sites (1)

Medical Faculty Foča

Foča, Bosnia and Herzegovina

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Nikola Stojanović, Prof. dr., DMD, PhD

  Medical Faculty Foča

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study is a single-arm non-randomized study. Baseline and the end of study results comparisons were performed using various statistical tests: To obtain distribution normality, appropriate transformations were applied. This study has two primary objectives: 1. Safety Evaluation: safety was analyzed through the number and severity of (if any) adverse events (AE) or serious adverse events (SAE). 2. Efficacy Evaluation: Functionality was approved primarily by radiographic evidence of the depth and volume new formed bone. These values for ALBO OS were compared with corresponding values for Bio Oss, a global world standard of such kind of medical devices. A cone-beam computed tomographic (CBCT) imaging with voxel resolution size of 0,3 mm, and FOV diameter of 100 mm and 75 mm height was used for estimation of the formed bone.

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 30, 2026
• Study Start: March 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: February 26, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BO (1)