Bone HealingNCT06885983
Healing After Augmentation of Alveolar Ridge Using Collagen Membrane
A study testing implant placement and Guided bone regeneration in people with Bone Healing and Augmentation, run by University of Belgrade at 1 site in Serbia.
Trial summary
One of the prerequisites for successful prosthetic implant therapy of patients is achieving the initial stability of the embedded implant, which largely depends on the width alveolar ridge, at the place of its installation. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Healing, Augmentation, Augmentation, Alveolar Ridge
- What is being tested?
- implant placement and Guided bone regeneration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSerbia
- Study dates
- 7 Mar 2025to 1 Nov 2029
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA I classification of health status,
- Non-smokers or consumption of up to 10 cigarettes per day,
- No signs of gingival inflammation,
- Late installation of implants,
- The possibility of achieving the primary stability of the implant,
- The dimension of the residual alveolar ridge for implant placement ≥5 mm wide, height ≥12 mm,
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- Diagnosed fenestration, dehiscence of buccal bony lamella ≤3 mm in size and/or thickness of buccal bone lamella ≤1.5 mm,
- Plaque index (PI) and gingival bleeding on provocation (KNP) <15% and probing depth (DS) <3 mm,
- Preserved cemento-enamel border (CGG) without the presence of non-carious cervical lesions (NCL), or the presence of a defect in the root area up to 1mm deep with preserved CGG,
- Preserved interjaw relationships.
Who cannot join
- Systemic acute administration of drugs up to 7 days before surgical intervention,
- Systemic chronic administration of steroids or non-steroidal anti-inflammatory drugs,
- History of oral surgical interventions in the last 4 months,
- Poor oral hygiene,
- Demonstrated hypersensitivity to collagen,
- Pregnancy and breastfeeding,
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- Patient withdrawal from the research protocol in any evaluation period,
- Patients who underwent standard augmentation of bone tissue with a substitute for bone and membrane, after implant installation,
- Participation in clinical research in the last 6 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Cellular and Tissue Mechanisms of Bone and Soft Tissue Healing After Augmentation of Alveolar Ridge With Cross-linked Type I Collagen Membrane
One of the prerequisites for successful prosthetic implant therapy of patients is achieving the initial stability of the embedded implant, which largely depends on the width alveolar ridge, at the place of its installation. Regenerative therapy of the horizontal dimension of the alveolar ridge simultaneously with the installation of implants is carried out using biocompatible materials; a basket of thin ones substitutes and collagen membranes. Clinical application of the collagen matrix to date has shown successful regeneration soft tissue in corrective surgery of the oral mucosa, by increasing the volume of the gingiva, approximately as effective as the application of a connective tissue graft from the palate. In the current literature, there is no data on the cellular effects of the regeneration of soft, a especially bone tissue, after the application of a membrane with cross-linked collagen type I, u regenerative therapy of fenestrations, dehiscence and buccal contour augmentations bone lamellae, simultaneously with implant placement. Also, tissue monitoring mechanisms of regeneration of soft and bone tissue, has not been shown in the literature so far controlled and systematized results using the Primescan digital program scans and software analysis of soft tissue regeneration parameters, as well as their own correlations with CBCT and clinical analysis.
Read the detailed description
The physiological process of bone tissue resorption after tooth extraction results in significant by changing the initial dimension of the alveolar ridge, due to horizontal and vertical resorption of bone tissue.this process is monitored and by a significant reduction in the volume of soft tissue and the width of the keratinized gingiva.Successful implant therapy is considered when the initial stability is achived of the embedded implant, which largely depends on the width alveolar ridge, at the place of its installation. However, despite achieving the initial stability, inadequate width of the alveolar ridge, and what according to the surgical protocol is a minimum of 1.5 mm. it is the cause of later complications due to present bone resorption processes and peri-implant soft tissue reduction. Regenerative therapy of the horizontal dimension of the alveolar ridge simultaneously with the installation of implants is carried out using biocompatible materials; a basket of thin ones substitutes and collagen membranes. Clinical trials have shown high degree of success of the regenerative therapy of the thinned buccal bone lamella, its deficiencies, as well as occurrences of dehiscence and fenestration, the treatment of which is carried out simultaneously with by inserting an implant. Moreover, simultaneous regenerative therapy of the mentioned bone defects with the installation of implants reduces the risk of buccal bony lamella and soft tissue collapse. Recent review paper and meta-analysis showed complete bony healing of fenestrations and dehiscence regardless of whether a bone substitute with or without collagen is used membrane, which is not the case if the operative region is covered only by mucoperiosteal flap, without regenerative therapy.
The primary goal of this research would be to determine the success of regenerative therapy bone and soft tissue from the buccal side.
- Conditions
- Bone Healing, Augmentation, Augmentation, Alveolar Ridge
- Being tested
- implant placement, Guided bone regeneration
- Keywords
- Implantation, Augmenatation, CROSS-LINKED TYPE I COLLAGEN MEMBRANE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implant placementProcedure or surgery
Late implant placement without regenerative therapy
Guided bone regenerationProcedure or surgery
Application of collagen membrane after implant placement.
| Study group | Role | What they receive |
|---|---|---|
| Implant placement with augmentation | Experimental | Patients who are indicated for implant rehabilitation. Guided tissue regeneration employs augmentation with cross-linked type I collagen membrane to create different gingiva phenotype. The material will be placed after implantation using the following standard surgical protocols. Collagen membrane will serve as a barrier for epithelial cells and thereby promote bone healing. Receives: Procedure: implant placement; Procedure: Guided bone regeneration |
| Implant placement without augmentation | Active comparator | Patient that needs implant placement in order for functional and aesthetic rehabilitation. Surgical procedures done in this group follow standard surgical protocols for implant placement without regenerative therapy. Receives: Procedure: implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achived volume of the bone after implant placement and augmentation
Assessment and comparative analysis quantity of newly formed bone and soft tissue using CBCT and digital, software analysis
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start7 Mar 2025
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone HealingStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Belgrade
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bozidar Brkovic, DDS, MSc, PhD, Professor, University of Belgrade
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06885983
- Sponsor's protocol ID
- 36/39/24
- Status last verified
- Mar 2026
- First submitted
- 13 Mar 2025
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cellular and Tissue Mechanisms of Bone and Soft Tissue Healing After Augmentation of Alveolar Ridge With Cross-linked Type I Collagen Membrane
- ClinicalTrials.gov ID
- NCT06885983
- Acronym / sponsor ID
- 36/39/24
- Conditions
- Bone Healing, Augmentation, Augmentation, Alveolar Ridge
- Keywords
- Implantation, Augmenatation, CROSS-LINKED TYPE I COLLAGEN MEMBRANE
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of BelgradeUniversity, hospital or other
- Study start
- 7 Mar 2025 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2029 (estimated)
- First posted
- 20 Mar 2025 (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.
One of the prerequisites for successful prosthetic implant therapy of patients is achieving the initial stability of the embedded implant, which largely depends on the width alveolar ridge, at the place of its installation. Regenerative therapy of the horizontal dimension of the alveolar ridge simultaneously with the installation of implants is carried out using biocompatible materials; a basket of thin ones substitutes and collagen membranes. Clinical application of the collagen matrix to date has shown successful regeneration soft tissue in corrective surgery of the oral mucosa, by increasing the volume of the gingiva, approximately as effective as the application of a connective tissue graft from the palate. In the current literature, there is no data on the cellular effects of the regeneration of soft, a especially bone tissue, after the application of a membrane with cross-linked collagen type I, u regenerative therapy of fenestrations, dehiscence and buccal contour augmentations bone lamellae, simultaneously with implant placement. Also, tissue monitoring mechanisms of regeneration of soft and bone tissue, has not been shown in the literature so far controlled and systematized results using the Primescan digital program scans and software analysis of soft tissue regeneration parameters, as well as their own correlations with CBCT and clinical analysis.
Detailed description
The physiological process of bone tissue resorption after tooth extraction results in significant by changing the initial dimension of the alveolar ridge, due to horizontal and vertical resorption of bone tissue.this process is monitored and by a significant reduction in the volume of soft tissue and the width of the keratinized gingiva.Successful implant therapy is considered when the initial stability is achived of the embedded implant, which largely depends on the width alveolar ridge, at the place of its installation. However, despite achieving the initial stability, inadequate width of the alveolar ridge, and what according to the surgical protocol is a minimum of 1.5 mm. it is the cause of later complications due to present bone resorption processes and peri-implant soft tissue reduction. Regenerative therapy of the horizontal dimension of the alveolar ridge simultaneously with the installation of implants is carried out using biocompatible materials; a basket of thin ones substitutes and collagen membranes. Clinical trials have shown high degree of success of the regenerative therapy of the thinned buccal bone lamella, its deficiencies, as well as occurrences of dehiscence and fenestration, the treatment of which is carried out simultaneously with by inserting an implant. Moreover, simultaneous regenerative therapy of the mentioned bone defects with the installation of implants reduces the risk of buccal bony lamella and soft tissue collapse. Recent review paper and meta-analysis showed complete bony healing of fenestrations and dehiscence regardless of whether a bone substitute with or without collagen is used membrane, which is not the case if the operative region is covered only by mucoperiosteal flap, without regenerative therapy.
The primary goal of this research would be to determine the success of regenerative therapy bone and soft tissue from the buccal side.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Implant placement with augmentation | Experimental | Procedure: implant placement, Procedure: Guided bone regenerationPatients who are indicated for implant rehabilitation. Guided tissue regeneration employs augmentation with cross-linked type I collagen membrane to create different gingiva phenotype. The material will be placed after implantation using the following standard surgical protocols. Collagen membrane will serve as a barrier for epithelial cells and thereby promote bone healing. |
| Implant placement without augmentation | Active comparator | Procedure: implant placementPatient that needs implant placement in order for functional and aesthetic rehabilitation. Surgical procedures done in this group follow standard surgical protocols for implant placement without regenerative therapy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- ASA I classification of health status,
Key exclusion criteria (9 listed)
- Systemic acute administration of drugs up to 7 days before surgical intervention,
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 |
|---|---|---|
| implant placementLate implant placement without regenerative therapy | Procedure or surgery | Implant placement with augmentation, Implant placement without augmentation |
| Guided bone regenerationApplication of collagen membrane after implant placement. | Procedure or surgery | Implant placement with augmentation |
Primary outcome
Achived volume of the bone after implant placement and augmentation
Time frame: 4 years
Assessment and comparative analysis quantity of newly formed bone and soft tissue using CBCT and digital, software analysis
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 11 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing implant placement and Guided bone regeneration in people with Bone Healing and Augmentation, run by University of Belgrade at 1 site in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. 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: enrolling by invitation, as of the sponsor's last update on 11 May 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 Serbia. 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?
Achived volume of the bone after implant placement and augmentation (time frame: 4 years). 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 11 May 2026.