AzTrials
AzTrials

Alveolar Bone PreservationNCT07814092

Use of Radiomics in the Evaluation of Bone Quality After Alveolar Ridge Preservation

A study testing Alveolar ridge preservation in people with Alveolar Bone Preservation, run by International Piezosurgery Academy at 1 site in Italy.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial summary

Bone regeneration techniques using biomaterials are commonly used in dentistry. These include alveolar ridge preservation, sinus lift, and bone ridge augmentation, which are safe procedures to maintain or restore bone for future dental implants. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Alveolar Bone Preservation
What is being tested?
Alveolar ridge preservation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteItaly
Study dates
1 Oct 2025to 1 Aug 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age between 18 and 75 y.o.
  • ASA < 3
  • Single-rooted teeth with indication to extraction
  • Sufficient bone height to permit standard-length implant placement (≥ 8.5 mm)
  • Presence of healthy oral mucosa with at least 3 mm of keratinized tissue
  • Presence of all socket walls
Show all 9Show fewer
  • Buccal bone thickness < 1 mm
  • Periodontal health or stability
  • Informed consent signed

Who cannot join

  • General contraindication to oral surgery
  • Inflammatory or autoimmune diseases
  • Medical history of neoplastic pathology treated with radio- and/or chemotherapy in the last five years in the head and neck district
  • Medical history of antiresorptive, antiangiogenetic or high dosage corticosteroideal therapy
  • Uncontrolled diabetes (HbA1c > 7%)
  • Allergy to porcine collagen
Show all 10Show fewer
  • Pregnancy
  • Missing of compliance
  • One or more missing post-extractive socket walls
  • Extraction of adjacent teeth in the 6 months following ARP

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Italy1 site
  • SC Clinica di Chirurgia Maxillofacciale e Odontostomatologia

    Trieste, Trieste, 34100

Other trials in Italy

About this study

Official title: Use of Radiomics in the Evaluation of Bone Quality After Alveolar Ridge Preservation.

Bone regeneration techniques using biomaterials are commonly used in dentistry. These include alveolar ridge preservation, sinus lift, and bone ridge augmentation, which are safe procedures to maintain or restore bone for future dental implants. These surgical interventions utilize specific materials following well-defined guidelines. However, to truly understand how much new bone has formed, a specific tissue analysis called histomorphometry is required, which entails analyzing the bone that will be removed during implant placement.

To simplify these evaluations, new techniques are being studied. One of these is radiomics, an approach that analyzes medical images (such as radiographs or CT scans) by searching for details that cannot be seen by the naked eye. The goal is to create predictive models that assist doctors in their decision-making. This study aims to evaluate the quality of bone regeneration using radiomics, analyzing radiographic images taken 6 months after the regeneration procedure. The collected data will be compared with the histomorphometry results and used to train advanced artificial intelligence models. The ultimate objective is to create a large database that allows doctors to evaluate post-regeneration images without having to resort to invasive sampling.

Read the detailed description

In implant surgery, alveolar ridge preservation (ARP) techniques represent a useful approach to maintain, following tooth extraction, bone volumes in case of a scheduled implant placement. Multiple ARP techniques are described in literature, and they differ from reconstruction techniques, since the aim of these techniques is to preserve the residual socket, not to recreate one or more missing bony walls. Furthermore, their use is strongly recommended in sockets with a residual buccal bone wall with a thickness lower than 1 mm, as the post-extractive socket undergoes physiological bone remodeling that starts from the inner portion of the alveolus, due to the loss of the periodontal ligament that induces the resorption of the so-called bundle bone. One of the ARP techniques requires the use of a heterologous bone substitutes to fill the entire socket, and superficially covered by a collagen resorbable membrane to avoid graft dispersion.

Following preservation, it is mandatory the execution of a CBCT exam to evaluate bone volumes prior to implant placement. This radiographic exam permits to correctly plan the insertion of the implant and can also be suggestive for the definition of the bone quality, which represents a criterium for the choice of an adequate implant design. Often, the pre-operative evaluation of bone quality does not coincide with the intra-operatory one, and still the agreement on radiographic evaluation has proven to be different on intra and inter-examiner opinion analysis.

In this sense, radiomics could represent a useful support to the dental surgeon. Radiomics is a quantitative approach to medical imaging, able to create predictive models, basing on the research of the so-called radiomic features, which are intrinsic characteristics of the image. In medical field, radiomics has been used in oncology, but without any valid use. In dentistry, only few research has been made. Specifically, in an article radiomics has been suggested to evaluate marginal bone loss around implants, whereas another one suggests the use of radiomics to create a classification of bone density.

The aim of this project is to develop, through radiomics, a predictive model to evaluate bone regeneration following ARP techniques. The assessment of bone quality is performed through histomorphometric analysis, which is then related to radiographical images.

The enrolled patients must meet specific inclusion and exclusion criteria and, in order to obtain a statistical significance, a sample size of 60 cases has been purposed.

The clinical pathway for participating patients is fully aligned with standard clinical practice and consists of the following sequential phases:

  • Screening and Recruitment: Patients are evaluated and recruited only if they meet all predefined inclusion criteria.
  • Surgical Phase 1 (Baseline): Tooth extraction is performed immediately followed by simultaneous alveolar ridge preservation (ARP).
  • Radiographic Assessment (6 Months): Six months after the preservation procedure, a Cone Beam Computed Tomography (CBCT) scan is performed to evaluate the regenerated bone volume.
  • Surgical Phase 2 (6 Months): During the implant surgery, a small bone biopsy is harvested (using the bone tissue that is normally removed during standard osteotomy site preparation) followed by the simultaneous placement of the dental implant (Resista OneTime). ISQ values are registered.
  • Prosthetic Phase (10 Months): Four months after implant placement (allowing for proper osseointegration), the final prosthetic phase is carried out to restore the tooth. ISQ values are registered.

Follow-up

  • 1 month after loading
  • 6 months after loading
  • 12 months after loading

Histological analysis Histological and histomorphometric evaluations will be carried out by a single investigator. To preserve tissue orientation, bone cores will be retained inside the trephine drills and rinsed with a cold 5% glucose solution (278 mOsm/L) to clear blood traces under isotonic conditions.

Fixation will be performed using a 10% buffered formalin solution (pH 7.2) for 3 days, followed by dehydration through an ascending ethanol series. After a 5-day pre-infiltration step in a 50% resin/alcohol mixture, the biopsies will be extracted from the drills and fully infiltrated with methacrylate resin.

Following a 12-day polymerization process, samples will be sectioned longitudinally with a high-precision silicon carbide disc to a thickness of approximately 50 μm, then ground and polished under running water down to 30 ± 10 μm. Sections will be mounted on glass slides and stained with acid fuchsin, toluidine blue, and Von Kossa. Once all analyses are completed, samples will be transferred to licensed medical waste companies for disposal in compliance with current legal regulations.

Being tested
Alveolar ridge preservation
Keywords
Alveolar ridge preservation, Radiomics, Post-extractive bone remodeling

What participants receive

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

  • Alveolar ridge preservationProcedure or surgery

    Also called Bone harvesting, Implant placement

    Following a minimally traumatic tooth extraction performed on patients enrolled in the study according to the inclusion criteria, thorough alveolar debridement is carried out, and the thickness of the residual buccal bone wall is measured. Subsequently, a classic, well-documented alveolar ridge preservation (ARP) technique is performed. This procedure involves completely filling the post-extraction socket with a xenograft biomaterial, which is then covered with a resorbable collagen membrane to prevent graft dispersion and promote healing by second intention. After a 6-month healing period, a bone biopsy core is harvested using a dedicated trephine drill, immediately followed by the simultaneous placement of the dental implant. CBCT scans are performed after 6 months, and a comparison between histomorphological and radiographic outcomes is performed.

Study groups in NCT07814092
Study groupRoleWhat they receive
Test groupExperimentalScreening and Recruitment: Patients are evaluated and recruited only if they meet all predefined inclusion criteria. * Surgical Phase 1 (Baseline): Tooth extraction is performed immediately followed by simultaneous alveolar ridge preservation (ARP). * Radiographic Assessment (6 Months): Six months after the preservation procedure, a Cone Beam Computed Tomography (CBCT) scan is performed to evaluate the regenerated bone volume. * Surgical Phase 2 (6 Months): During the implant surgery, a small bone biopsy is harvested (using the bone tissue that is normally removed during standard osteotomy site preparation) followed by the simultaneous placement of the dental implant. * Prosthetic Phase (10 Months): Four months after implant placement (allowing for proper osseointegration), the final prosthetic phase is carried out to restore the tooth.
Receives: Procedure: Alveolar ridge preservation

What is being measured

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

  1. Radiomic features

    The primary outcome of this study is to evaluate the existence and predictive value of radiomic features derived from pre-operative CBCT scans. These digital imaging features will be correlated and compared with histomorphometric outcomes obtained from the bone biopsy cores harvested during the simultaneous implant placement procedure

    Measured: perioperatively

Secondary outcomes (2)
  1. Histomorphometric values

    The evaluated outcome measures are histomorphometric parameters-specifically the relative percentages of regenerated bone, residual graft material, and native bone expressed relative to total bone volume. Histological analysis is conducted on biopsy core samples (3 mm in diameter with variable length depending on the selected implant dimension) harvested with a trephine bur concurrently with implant placement.

    Measured: periprocedural

  2. Implant survival

    Measured through radiographic evaluation and ISQ values. Expressed as millimeters of peri-implant bone loss, measured on periapical follow-up radiographs (measured from bone crest to implant-abutment junction)

    Measured: 1 year

Timeline

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

  1. First posted10 Sep 2026
  2. Study start1 Oct 2025
  3. Primary completion1 Mar 2027 (estimated)
  4. Study completion1 Aug 2027 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07814092
Sponsor's protocol ID
Units 09/2024
Status last verified
Sep 2026
First submitted
4 Aug 2026
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Troiano G, Fanelli F, Rapani A, Zotti M, Lombardi T, Zhurakivska K, Stacchi C. Can radiomic features extracted from intra-oral radiographs predict physiological bone remodelling around dental implants? A hypothesis-generating study. J Clin Periodontol. 2023 Jul;50(7):932-941. doi: 10.1111/jcpe.13797. Epub 2023 Mar 3.

    PubMed 36843362
  • Mayerhoefer ME, Materka A, Langs G, Haggstrom I, Szczypinski P, Gibbs P, Cook G. Introduction to Radiomics. J Nucl Med. 2020 Apr;61(4):488-495. doi: 10.2967/jnumed.118.222893. Epub 2020 Feb 14.

    PubMed 32060219
  • van Timmeren JE, Cester D, Tanadini-Lang S, Alkadhi H, Baessler B. Radiomics in medical imaging-"how-to" guide and critical reflection. Insights Imaging. 2020 Aug 12;11(1):91. doi: 10.1186/s13244-020-00887-2.

    PubMed 32785796
  • Stacchi C, Spinato S, Lombardi T, Bernardello F, Bertoldi C, Zaffe D, Nevins M. Minimally Invasive Management of Implant-Supported Rehabilitation in the Posterior Maxilla, Part II. Surgical Techniques and Decision Tree. Int J Periodontics Restorative Dent. 2020 May/Jun;40(3):e95-e102. doi: 10.11607/prd.4498.

    PubMed 32233185

Questions about this trial

What is this clinical trial studying?

A study testing Alveolar ridge preservation in people with Alveolar Bone Preservation, run by International Piezosurgery Academy at 1 site in Italy.

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 9 inclusion and 10 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 10 Sep 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 Italy. 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?

Radiomic features (time frame: perioperatively). 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 NCT07814092, which also lists 4 linked publications.

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 10 Sep 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in