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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Albo Os group | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albo Os | Device | ALBO-OS is a bone substitute designed to fulfill the principal requirements of an ideal graft material for bone regeneration, 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Healing of periodontal pockets or alveolar sockets without any known adverse events |
| up to 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 | Changes of the depth of periodontal pockets: Changes 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 | Changes 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 (or alveolar socket following alveolar ridge preservation), 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
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| Measure | Description | Time Frame |
|---|---|---|
| Buccal bone plate thickness (in mm), by means of CBCT | Buccal bone plate thickness (BBP) in mm will be measured at standardized vertical levels apical to the crestal bone level, which is defined as the most coronal point of the alveolar ridge. Measurements will be performed perpendicular to the outer contour of the buccal cortical surface at the following levels: BBP-1: 1 mm apical to the crest; BBP-3: 3 mm apical to the crest; BBP-5: 5 mm apical to the crest |
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Inclusion Criteria in case of regenerative periodontal treatment:
Exclusion Criteria in case of regenerative periodontal treatment:
Eligibility criteria if ARP was indicated:
Inclusion criteria: age ≥18 years; good general health; non-smokers or light smokers (up to 10 cigarettes per day); no active periodontal disease; presence of single or multiple hopeless teeth; tooth/teeth to be extracted having at least one neighboring tooth and at least two socket walls with 3 mm of alveolar bone height; more than two residual teeth after extraction to be used as references during image superimposition.
Exclusion criteria: pregnancy or lactation; presence of systemic conditions and medications that alter bone metabolism (i.e. uncontrolled diabetes mellitus, renal or hepatic impairment, immunodeficiency, severe autoimmune diseases, malignancy, radiotherapy or chemotherapy in the past 5 years, intake of corticosteroids, bisphosphonates or other anti-resorptive drugs); active periodontal disease; heavy smoking (more than 10 cigarettes per day).
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| Name | Affiliation | Role |
|---|---|---|
| Nikola Stojanović, Prof. dr., DMD, PhD | Medical Faculty Foča | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Faculty Foča | Foca | Bosnia and Herzegovina |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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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:
Secondary, funcTionality was evaluated via histological analysis of bone tissue samples harvested prior to implant placement four months following alveolar ridge preservation (ARP).
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|
| baseline, 4 and 6 months after the surgical procedure |
| Healing bone tissue inside periodontal pockets with an initial probing depth of more than 5 mm (or alveolar socket following alveolar ridge preservation), 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
| baseline, 4 and 6 months after the surgical procedure |
| 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)). | 6 months |
| Alveolar ridge height in mm (by means of CBCT) | A horizontal reference line is defined tangential to the most apical point of the extraction socket, whereas a vertical reference line was marked perpendicular to it, passing through the central axis of the socket, respectively. Regarding alveolar ridge height two vertical dimensions will be evaluated along the vertical reference line. The vestibular (VH) and oral (OH) heights of alveolar ridge (in mm) are defined as the distances from the horizontal reference line to the most coronal points of the buccal and oral aspects of the bone cortical level (BCL), respectively. | baseline and 4 months following surgical procedure |
| Alveolar ridge width in mm (by means of CBCT) | For measurements of alveolar ridge width (in mm) three horizontal parameters are positioned perpendicular to the vertical reference line at three standardized levels apical to the crestal bone level: HW-1: 1 mm apical to the crest; HW-3: 3 mm apical to the crest; HW-5: 5 mm apical to the crest | Baseline and 4 months following surgical procedure |
| Histological analysis | Bone samples harvested at the time of implant placement following alveolar ridge preservation will be evaluated and histologically described in detail. The hard tissue specimens will fixed in 4% buffered buffered formaldehyde, following by decalcification in formic acid idehydration with increasing concentrations of ethanol. The next step will be embedding the tissue in a supportive medium-paraffin wax. Serial longitudinal sections measuring 0.004 mm in thickness will be prepared by means of microtome. Finally, the sections will be stained in Hematoxylin and Eosin to make cell components visible and mounted for microscopic examination. The histological examination will be carried out using light microscopy (Leitz Labor Lux S fluorescent microscope, Ernst Leitz Wetzlar GMBH, Wetzlar, Germany). The morphometric evaluation was performed at 400× magnification using a digital camera system (Leica DFC295, Wetzlar, Germany). | 4 months following ARP |
| baseline and 4 months following surgical procedure |
| The percentage of radiographic linear socket fill (%), by means of CBCT | (H(before preservation)-H(after preservation))/(H(before preservation)) x 100=% linear socket fill | 4 months following ARP |
| Bleeding on probing (by means of periodontal probe) | The subgingival space will be gently probed with a periodontal probe from the distal to the mesial, both on the vestibular and the oral side. If bleeding occured about 10 seconds after probing it was recorded as a positive (+) value. If there is no bleeding, it was recorded as a negative value (-). All present, fully erupted teeth, except for the third molars will be evaluated. The index value will be expressed as a percentage. This will be done by dividing the number of tooth surfaces with bleeding, with the number of examined tooth surfaces, and multiply it by 100. | baseline and 4 months following surgical procedure |