PeriodontitisNCT07500961
Novel Bone Substitute (ALBO-OS) in Patients With Periodontal Disease or Who Need Alveolar Preservation
A study testing Albo Os in people with Periodontitis, run by Albos d.o.o. Beograd at 1 site in Bosnia and Herzegovina.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis
- What is being tested?
- Albo Os
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBosnia and Herzegovina
- Study dates
- 1 Apr 2026to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria in case of regenerative periodontal treatment:
- 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
Exclusion Criteria in case of regenerative periodontal treatment:
- 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
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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read more
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
- Being tested
- Albo Os
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albo OsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Albo Os group | Experimental | Not described Receives: Device: Albo Os |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing of periodontal pockets or alveolar sockets without any known adverse events
- vital signs, and laboratory tests were monitored
- in case of an adverse event occurrence, the symptoms, onset date, resolution date, and the degree of severity will be recorded. The three levels of adverse events intensity are defined: mild, moderate, and severe.
Measured: 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.
Measured: 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.
Measured: 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
- Mild inflammation (slight color change and edema, but no bleeding on probing)
- Moderate inflammation (redness, edema, glazing, and bleeding on probing)
- Severe inflammation (marked redness and edema, ulceration, and tendency to spontaneous bleeding.
Measured: 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
- - 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.
- - Moderate accumulation of soft deposit within the gingival pockets, or the tooth and the gingival margin, which can be seen with the naked eye.
- - 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).
Measured: 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)).
Measured: 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.
Measured: 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
Measured: 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).
Measured: 4 months following ARP
Secondary outcomes (3)
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
Measured: 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
Measured: 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.
Measured: baseline and 4 months following surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start1 Apr 2026
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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. 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. Secondary, funcTionality was evaluated via histological analysis of bone tissue samples harvested prior to implant placement four months following alveolar ridge preservation (ARP).
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albos d.o.o. Beograd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nikola Stojanović, Prof. dr., DMD, PhD, Principal investigator, Medical Faculty Foča
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07500961
- Sponsor's protocol ID
- ALMBIH CT ID 08-07.5-1754-3/23
- Status last verified
- Jul 2026
- First submitted
- 17 Mar 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07500961
- Acronym / sponsor ID
- ALMBIH CT ID 08-07.5-1754-3/23
- Conditions
- Periodontitis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Albos d.o.o. BeogradIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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. 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. Secondary, funcTionality was evaluated via histological analysis of bone tissue samples harvested prior to implant placement four months following alveolar ridge preservation (ARP).
| Arm | Type | Receives |
|---|---|---|
| Albo Os group | Experimental | Device: Albo Os |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Albo OsALBO-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. | Device | Albo Os group |
Primary outcome
Healing of periodontal pockets or alveolar sockets without any known adverse events
Time frame: up to 12 months
* vital signs, and laboratory tests were monitored * in case of an adverse event occurrence, the symptoms, onset date, resolution date, and the degree of severity will be recorded. The three levels of adverse events intensity are defined: mild, moderate, and severe.
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
Time frame: 6 months
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.
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
Time frame: 6 months
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.
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
Time frame: baseline, 4 and 6 months after the surgical procedure
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.
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
Time frame: baseline, 4 and 6 months after the surgical procedure
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).
Healing bone tissue inside periodontal pockets with an initial probing depth of more than 5 mm, explained by MMI
Time frame: 6 months
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)).
Alveolar ridge height in mm (by means of CBCT)
Time frame: baseline and 4 months following surgical procedure
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.
Alveolar ridge width in mm (by means of CBCT)
Time frame: Baseline and 4 months following surgical procedure
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
Histological analysis
Time frame: 4 months following ARP
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).
3 secondary outcomes
Buccal bone plate thickness (in mm), by means of CBCT
Time frame: baseline and 4 months following surgical procedure
The percentage of radiographic linear socket fill (%), by means of CBCT
Time frame: 4 months following ARP
Bleeding on probing (by means of periodontal probe)
Time frame: baseline and 4 months following surgical procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nikola Stojanović, Prof. dr., DMD, PhD principal investigator
Medical Faculty Foča
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Albo Os in people with Periodontitis, run by Albos d.o.o. Beograd at 1 site in Bosnia and Herzegovina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bosnia and Herzegovina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing of periodontal pockets or alveolar sockets without any known adverse events (time frame: up to 12 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.