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Socket Preservationsocket healingNCT07031895

The Effectiveness of Hyaluronic Acid in Bone Regeneration

A study testing a bovine-derived graft/xenograft enriched with hyaluronic acid and a standart bovine-derived graft/xenograft in people with Socket Preservation, run by TC Erciyes University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Bone loss due to resorption is commonly observed in the alveolar socket following tooth extraction. This situation makes it difficult to preserve sufficient bone volume that would allow for ideal implant placement in cases requiring dental implants. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Socket Preservation
What is being tested?
a bovine-derived graft/xenograft enriched with hyaluronic acid and a standart bovine-derived graft/xenograft
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
2 Sep 2025to 1 Sep 2026
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

  • Socket type: Sockets with less than 50% bone resorption in the buccal and palatal/lingual walls according to the Kim JJ classification (Type I-IVa)
  • Age range: 18-65 years
  • Absence of active periodontal disease
  • No systemic diseases
  • Patients who will attend regular follow-up visits

Who cannot join

  • Smoking
  • Uncontrolled systemic disease
  • Presence of infection in the area
  • Use of medications affecting bone metabolism
  • Pregnancy or lactation

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Duygu Kılıç, PhD contact

+903522076600

duygukilic4838@gmail.com

About this study

Official title: Evaluation of the Efficacy of Xenograft Containing Hyaluronic Acid in Socket Preservation Procedure Radiologically and Histologically: A Prospective Randomized Controlled Clinical Study

Bone loss due to resorption is commonly observed in the alveolar socket following tooth extraction. This situation makes it difficult to preserve sufficient bone volume that would allow for ideal implant placement in cases requiring dental implants. Alveolar ridge preservation is a procedure aimed at minimizing bone resorption and preserving the volume and morphology of the alveolar ridge after tooth extraction.

The aim of this study is to evaluate the clinical effectiveness of socket preservation using a xenograft enriched with hyaluronic acid in patients with defective extraction sockets.

Read more

This study is designed as a randomized, controlled clinical trial including three parallel groups:

Study group - Patients whose alveolar bone was evaluated using cone-beam computed tomography (CBCT) will undergo tooth extraction, followed by the application of a bovine-derived graft/xenograft enriched with hyaluronic acid into the socket. Patients will be evaluated clinically, radiologically, and histologically at the 4th month. Dental implants will be placed in the edentulous areas where the graft was applied. Bone samples will be taken during the preparation of the implant sockets, and the bone tissue will be examined histologically. A third CBCT scan will be taken 6 months after implant placement to assess new bone formation and implant success radiographically.

Comparison group - Patients whose alveolar bone was evaluated using CBCT will undergo tooth extraction, followed by the application of a standard bovine-derived graft/xenograft into the socket. Patients will be evaluated clinically, radiologically, and histologically at the 4th month. Dental implants will be placed in the edentulous areas where the graft was applied. Bone samples will be taken during the preparation of the implant sockets, and the bone tissue will be examined histologically. A third CBCT scan will be taken 6 months after implant placement to assess new bone formation and implant success radiographically.

Control group - Patients whose alveolar bone was evaluated using CBCT will undergo tooth extraction, and the socket will be left to heal naturally without the application of any graft material. Patients will be evaluated clinically, radiologically, and histologically at the 4th month. Dental implants will be placed in the edentulous areas. Bone samples will be taken during the preparation of the implant sockets, and the bone tissue will be examined histologically. A third CBCT scan will be taken 6 months after implant placement to assess new bone formation and implant success radiographically.

Read the detailed description

Following tooth extraction, volume loss due to bone resorption is observed in the alveolar socket. This condition complicates the preservation of sufficient bone volume that would allow for ideal implant placement in cases requiring dental implants. Alveolar ridge preservation is a procedure aimed at minimizing bone resorption and maintaining the volume and morphology of the alveolar ridge after tooth extraction. In this procedure, the goal is to provide structural support and a scaffold for new bone formation by using materials such as autogenous grafts, allografts, xenografts, barrier membranes, platelet-rich fibrin, bone morphogenetic proteins, and other growth factors. This approach supports bone regeneration by promoting osteogenesis and osteoconduction. Although current methods maintain their effectiveness, variability in outcomes is still observed. This highlights the need for more extensive research into different graft materials and innovative approaches.

Hyaluronic acid has emerged as a promising biomaterial for alveolar ridge preservation due to its multifaceted biological effects on tissue regeneration and wound healing. Its viscoelastic properties help maintain hydration and structural integrity at the graft site, reducing graft shrinkage and supporting vertical stability. Additionally, by interacting with cell surface receptors, it stimulates osteoblast activity and inhibits osteoclastogenesis, thereby contributing to increased bone density and improved biointegration of the graft material. Clinical studies have also demonstrated that hyaluronic acid enhances angiogenesis, strengthening the osteoconductive properties of graft materials and optimizing clinical outcomes in alveolar ridge preservation.

The aim of this study is to evaluate the clinical efficacy of socket preservation using a xenograft enriched with hyaluronic acid in patients with defective extraction sockets. Over a 10-month period, the study group receiving a hyaluronic acid-enriched xenograft will be compared with a control group receiving a standard xenograft and another control group left to natural healing after tooth extraction. Evaluated outcomes include horizontal and vertical bone gain, graft stability, residual graft, bone marrow presence, and bone mineral density.

This study is designed as a randomized, controlled clinical trial including three parallel groups:

Study group - Patients whose alveolar bone is pre-evaluated using cone-beam computed tomography (CBCT) will receive a bovine-derived graft/xenograft enriched with hyaluronic acid in the extraction socket after tooth removal. Patients will be evaluated clinically, radiologically, and histologically at 4 months. Dental implants will be placed in the edentulous areas where the graft was applied. Bone samples will be collected during the preparation of the implant sockets and analyzed histologically. A third CBCT scan will be performed 6 months after implant placement to radiographically assess new bone formation and implant success.

Comparison group - Patients whose alveolar bone is pre-evaluated using CBCT will receive a standard bovine-derived graft/xenograft in the extraction socket after tooth removal. Patients will be evaluated clinically, radiologically, and histologically at 4 months. Dental implants will be placed in the grafted areas. Bone samples will be collected during implant socket preparation and analyzed histologically. A third CBCT scan will be performed 6 months after implant placement to assess new bone formation and implant success.

Control group - Patients whose alveolar bone is pre-evaluated using CBCT will undergo tooth extraction without graft material application, allowing for natural healing of the socket. Patients will be evaluated clinically, radiologically, and histologically at 4 months. Dental implants will be placed in the edentulous areas. Bone samples will be collected during the preparation of the implant sockets and analyzed histologically. A third CBCT scan will be performed 6 months after implant placement to assess new bone formation and implant success.

Histopathological Studies Tissue samples collected for histological analysis will be fixed in 10% formaldehyde solution for 72 hours. After fixation, samples will undergo decalcification using a solution composed of 10% formaldehyde, 80% distilled water, and 10% nitric acid. Following decalcification, standard histological tissue processing will be performed. Prepared sections will be stained with Hematoxylin and Eosin (H\&E) for general histological structure and Masson's Trichrome (MT) specifically for connective tissue evaluation. Microscopic evaluation will be performed using an Olympus BX51 light microscope (Olympus Corp., Tokyo, Japan) according to defined criteria, and measurements will be analyzed statistically using the ImageJ software program.

The obtained histological images will be evaluated according to Jerry Bouquot's classification (UTHSC School of Dentistry, Houston):

Grade 0 - No bone formation observed

Grade 1 - Minimal bone formation observed

Grade 2 - Moderate bone formation observed

Grade 3 - Considerable bone formation observed

Grade 4 - Extensive bone formation observed

Tissues collected from the study will also be analyzed using immunohistochemical staining to show the expression of Tartrate Resistant Acid Phosphatase (TRAP) and Alkaline Phosphatase (AP). For the different experimental groups, AP (Anti-Alkaline Phosphatase Antibody 100 μl, Abcam cat no: ab95462) will be used to demonstrate osteoblast activity, and TRAP (Rabbit Anti TRAP/Tartrate Resistant Acid Phosphatase Polyclonal Antibody, Bioss cat no: bs-6434R) will be used to determine osteoclast activity.

ImageJ software will be used at X40 magnification to calculate the intensity of AP and TRAP immunoreactivity in all femoral sections collected from the subjects in all experimental groups, and the results will be recorded.

Being tested
a bovine-derived graft/xenograft enriched with hyaluronic acid, a standart bovine-derived graft/xenograft
Keywords
Socket Preservation, hyaluronic acid, bone formation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • a bovine-derived graft/xenograft enriched with hyaluronic acidCombination product

    In study group a bovine-derived graft/xenograft enriched with hyaluronic acid will be placed in the extraction socket after tooth removal.

  • a standart bovine-derived graft/xenograftCombination product

    In comparison group a standard bovine-derived graft/xenograft will be placed in the extraction socket after tooth removal.

Study groups in NCT07031895
Study groupRoleWhat they receive
Bovine-derived graft/xenograft enriched with hyaluronic acid study groupExperimentalStudy group - Patients whose alveolar bone is pre-evaluated using cone-beam computed tomography (CBCT) will receive a bovine-derived graft/xenograft enriched with hyaluronic acid in the extraction socket after tooth removal. Patients will be evaluated clinically, radiologically, and histologically at 4 months. Dental implants will be placed in the edentulous areas where the graft was applied. Bone samples will be collected during the preparation of the implant sockets and analyzed histologically. A third CBCT scan will be performed 6 months after implant placement to radiographically assess new bone formation and implant success.
Receives: Combination Product: a bovine-derived graft/xenograft enriched with hyaluronic acid
Standard bovine-derived graft/xenograft comparison groupActive comparatorComparison group - Patients whose alveolar bone is pre-evaluated using CBCT will receive a standard bovine-derived graft/xenograft in the extraction socket after tooth removal. Patients will be evaluated clinically, radiologically, and histologically at 4 months. Dental implants will be placed in the grafted areas. Bone samples will be collected during implant socket preparation and analyzed histologically. A third CBCT scan will be performed 6 months after implant placement to assess new bone formation and implant success.
Receives: Combination Product: a standart bovine-derived graft/xenograft
Control group without graft materialNo interventionControl group - Patients whose alveolar bone is pre-evaluated using CBCT will undergo tooth extraction without graft material application, allowing for natural healing of the socket. Patients will be evaluated clinically, radiologically, and histologically at 4 months. Dental implants will be placed in the edentulous areas. Bone samples will be collected during the preparation of the implant sockets and analyzed histologically. A third CBCT scan will be performed 6 months after implant placement to assess new bone formation and implant success.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. bone formation

    At the 4-month follow-up, dental implants will be placed in the edentulous areas where grafts were applied. During the preparation of the implant sockets, bone samples will be collected and examined histologically.

    Tissue samples obtained for histological examination will be fixed in a 10% formaldehyde solution for 72 hours. Following fixation, the tissues will undergo a decalcification process. After decalcification, a routine histological tissue processing protocol will be applied.

    The obtained histological images will be evaluated according to the classification by Jerry Bouquot.

    Tissues obtained from the study will also be analyzed using immunohistochemical staining under a light microscope (Olympus BX51, Tokyo, Japan). The sections will be examined under a light microscope (Olympus BX51, Tokyo, Japan). For all femoral sections obtained from subjects in the experimental groups, the intensity of AP and TRAP immunoreactivity will be calculated at 40× magnification using the ImageJ.

    Measured: until the end of the histological examination 4 months after the socket preservation procedure

Secondary outcomes (1)
  1. Radiographic bone evaluation

    Cone-beam computed tomography (CBCT) scans will be obtained from each patient at three different time points throughout the study:

    Before socket preservation

    At 4 months after socket preservation (prior to implantation)

    At 6 months after implantation

    Using these scans, bone density, vertical and horizontal gain parameters will be measured.

    Measured: up to the radiographic evaluations at 4 and 10 months after the socket preservation procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2025
  2. Study start2 Sep 2025 (estimated)
  3. Primary completion1 Apr 2026 (estimated)
  4. Study completion1 Sep 2026 (estimated)

Resources

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
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07031895
Sponsor's protocol ID
2025/184-F
Acronym
socket healing
Status last verified
Aug 2025
First submitted
2 Jun 2025
Last updated
20 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: We do not wish to share data due to the possibility that patients may not consent to the sharing of personal information.

Publications

  • Kloss FR, Kau T, Heimes D, Kammerer PW, Kloss-Brandstatter A. Enhanced alveolar ridge preservation with hyaluronic acid-enriched allografts: a comparative study of granular allografts with and without hyaluronic acid addition. Int J Implant Dent. 2024 Oct 9;10(1):42. doi: 10.1186/s40729-024-00559-6.

    PubMed 39382763

Questions about this trial

What is this clinical trial studying?

A study testing a bovine-derived graft/xenograft enriched with hyaluronic acid and a standart bovine-derived graft/xenograft in people with Socket Preservation, run by TC Erciyes University.

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 5 inclusion and 5 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 20 Aug 2025. 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 Duygu Kılıç, PhD (+903522076600, duygukilic4838@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

bone formation (time frame: until the end of the histological examination 4 months after the socket preservation procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07031895, which also lists 1 linked publication.

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 20 Aug 2025.

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