Alveolar Bone ResorptionNCT07496437
Is Cross-linked Hyaluronic Acid a Biologic Alternative for Alveolar Ridge Preservation?
A study testing DBBM + FGG and Hyaluronic acid + collagen sponge + FGG in people with Alveolar Bone Resorption and Alveolar Ridge Enlargement, run by Medical University of Vienna.
Trial summary
Even after atraumatic tooth removal and/or immediate implant placement, some reduction of the alveolar ridge dimension is expected. To counteract (or limit) this reduction, alveolar ridge preservation technique (ARP) was developed. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Resorption, Alveolar Ridge Enlargement, Tooth Extraction
- What is being tested?
- DBBM + FGG and Hyaluronic acid + collagen sponge + FGG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 31 Dec 2028
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients elder than 18 years in need of (2) maxillary non-molar tooth extraction, and (3) later rehabilitation with delayed implant installation.
Who cannot join
- Patients with chronic diseases (e.g., uncontrolled diabetes mellitus, etc.) and/or (2) taking any medication, influencing hard or soft-tissue healing; (3) acute pain/infection or (4) presence of a fistula at the extraction site; (5) untreated periodontal disease; (6) >25% of the buccal bone plate missing after tooth extraction; (7) pregnancy; (8) history of hypersensitivity or allergy to xHyA or xenogenic bone substitute material; and (9) inability to attend the follow-up appointments.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Is Cross-linked Hyaluronic Acid a Biologic Alternative for Alveolar Ridge Preservation? A Single-blind, Randomized Controlled Clinical Trial
Even after atraumatic tooth removal and/or immediate implant placement, some reduction of the alveolar ridge dimension is expected. To counteract (or limit) this reduction, alveolar ridge preservation technique (ARP) was developed. However, standard ARP techniques, such as grafting with bone substitutes, have some concerns, such as a long healing time prior to implant installation, residual graft particles, and often the need of re-grafting at implant installation. To overcome some of these limitations biologics have been discussed as an alternative approach, such as cross-linked hyaluronic acid (xHyA). However, whether the use of biologics only can achieve comparable results to the standard techniques, has yet to be answered.
The aim of the present single-blind, randomized controlled clinical trial is to test non-inferiority in terms of mid-buccal alveolar ridge height resorption 4 months after ARP between 1) control/standard treatment (i.e., grafting with bone substitutes and socket seal) and 2) test treatment (i.e., xHyA applied with a collagen sponge and socket seal) at maxillary non-molar teeth.
Forty-eight patients will be included and randomly assigned to one of the following 2 groups: 1) control group: standard ARP with deproteinized bovine bone material and covering of the socket with a free gingival graft (FGG) (n=24), 2) test group: application of xHyA soaked in a collagen sponge and covered by a FGG (n=24). The primary outcome parameter is the extent of mid-buccal alveolar ridge height resorption after 4 months, i.e., prior to implant installation, and the sample size calculation is based on a non-inferiority limit of 0.6 mm. The secondary outcome parameters are frequency of additional grafting at implant installation due to 1) a bony dehiscence or fenestration, 2) a thin buccal bone (< 1.5 mm), or 3) contour improvement, cervical alveolar ridge width, alveolar ridge volume, histomorphometric assessment of alveolar ridge healing, feasibility of implant installation, aesthetic outcome parameters, patient reported outcome measures, changes in keratinized mucosa width, soft tissue healing, and assessment of postoperative complications. Patients will be followed up to 1 year after prosthetic restoration.
- Being tested
- DBBM + FGG, Hyaluronic acid + collagen sponge + FGG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBBM + FGGProcedure or surgery
After tooth extraction, DBBM and FGG will be used for ARP.
Hyaluronic acid + collagen sponge + FGGProcedure or surgery
After tooth extraction, Hyaluronic acid, a collagen sponge and FGG will be used for ARP.
| Study group | Role | What they receive |
|---|---|---|
| DBBM + FGG | Active comparator | Deproteinized bovine bone mineral particles covered by free gingival graft Receives: Procedure: DBBM + FGG |
| Hyaluronic acid + collagen sponge + FGG | Experimental | Hyaluronic acid applied with collagen sponge and covered by free gingival graft Receives: Procedure: Hyaluronic acid + collagen sponge + FGG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extent of mid-buccal alveolar ridge height resorption
The extent of mid-buccal alveolar ridge height resorption will be measured 4 months after ARP based on CBCT scans.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone ResorptionStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danijel Domic DMD, Medical University of Vienna
- Investigators
- Danijel Domic, Dr.med.dent., Principal investigator, Department of Oral Surgery, Medical University of Vienna, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07496437
- Sponsor's protocol ID
- 2030/2023
- Status last verified
- Mar 2026
- First submitted
- 22 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Cross-linked Hyaluronic Acid a Biologic Alternative for Alveolar Ridge Preservation? A Single-blind, Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07496437
- Acronym / sponsor ID
- 2030/2023
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 27 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.
Even after atraumatic tooth removal and/or immediate implant placement, some reduction of the alveolar ridge dimension is expected. To counteract (or limit) this reduction, alveolar ridge preservation technique (ARP) was developed. However, standard ARP techniques, such as grafting with bone substitutes, have some concerns, such as a long healing time prior to implant installation, residual graft particles, and often the need of re-grafting at implant installation. To overcome some of these limitations biologics have been discussed as an alternative approach, such as cross-linked hyaluronic acid (xHyA). However, whether the use of biologics only can achieve comparable results to the standard techniques, has yet to be answered.
The aim of the present single-blind, randomized controlled clinical trial is to test non-inferiority in terms of mid-buccal alveolar ridge height resorption 4 months after ARP between 1) control/standard treatment (i.e., grafting with bone substitutes and socket seal) and 2) test treatment (i.e., xHyA applied with a collagen sponge and socket seal) at maxillary non-molar teeth.
Forty-eight patients will be included and randomly assigned to one of the following 2 groups: 1) control group: standard ARP with deproteinized bovine bone material and covering of the socket with a free gingival graft (FGG) (n=24), 2) test group: application of xHyA soaked in a collagen sponge and covered by a FGG (n=24). The primary outcome parameter is the extent of mid-buccal alveolar ridge height resorption after 4 months, i.e., prior to implant installation, and the sample size calculation is based on a non-inferiority limit of 0.6 mm. The secondary outcome parameters are frequency of additional grafting at implant installation due to 1) a bony dehiscence or fenestration, 2) a thin buccal bone (< 1.5 mm), or 3) contour improvement, cervical alveolar ridge width, alveolar ridge volume, histomorphometric assessment of alveolar ridge healing, feasibility of implant installation, aesthetic outcome parameters, patient reported outcome measures, changes in keratinized mucosa width, soft tissue healing, and assessment of postoperative complications. Patients will be followed up to 1 year after prosthetic restoration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DBBM + FGG | Active comparator | Procedure: DBBM + FGGDeproteinized bovine bone mineral particles covered by free gingival graft |
| Hyaluronic acid + collagen sponge + FGG | Experimental | Procedure: Hyaluronic acid + collagen sponge + FGGHyaluronic acid applied with collagen sponge and covered by free gingival graft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients elder than 18 years in need of (2) maxillary non-molar tooth extraction, and (3) later rehabilitation with delayed implant installation.
Key exclusion criteria (1 listed)
- Patients with chronic diseases (e.g., uncontrolled diabetes mellitus, etc.) and/or (2) taking any medication, influencing hard or soft-tissue healing; (3) acute pain/infection or (4) presence of a fistula at the extraction site; (5) untreated periodontal disease; (6) >25% of the buccal bone plate missing after tooth extraction; (7) pregnancy; (8) history of hypersensitivity or allergy to xHyA or xenogenic bone substitute material; and (9) inability to attend the follow-up appointments.
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 |
|---|---|---|
| DBBM + FGGAfter tooth extraction, DBBM and FGG will be used for ARP. | Procedure or surgery | DBBM + FGG |
| Hyaluronic acid + collagen sponge + FGGAfter tooth extraction, Hyaluronic acid, a collagen sponge and FGG will be used for ARP. | Procedure or surgery | Hyaluronic acid + collagen sponge + FGG |
Primary outcome
Extent of mid-buccal alveolar ridge height resorption
Time frame: 4 months
The extent of mid-buccal alveolar ridge height resorption will be measured 4 months after ARP based on CBCT scans.
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 27 Mar 2026.
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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.
Danijel Domic, Dr.med.dent. principal investigator
Department of Oral Surgery, Medical University of Vienna, Austria
Questions about this trial
What is this clinical trial studying?
A study testing DBBM + FGG and Hyaluronic acid + collagen sponge + FGG in people with Alveolar Bone Resorption and Alveolar Ridge Enlargement, run by Medical University of Vienna.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Danijel Domic, Dr.med.dent. (+43(1)400704101, danijel.domic@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extent of mid-buccal alveolar ridge height resorption (time frame: 4 months). 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 27 Mar 2026.