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Enrolling by invitationNCT07814092Updated Sep 10, 2026

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

An interventional study of Alveolar ridge preservation in Alveolar Bone Preservation, sponsored by International Piezosurgery Academy. Enrolling by invitation at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by International Piezosurgery Academy · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Alveolar Bone Preservation

Keywords

  • Alveolar ridge preservation
  • Radiomics
  • Post-extractive bone remodeling
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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
  • Buccal bone thickness \< 1 mm
  • Periodontal health or stability
  • Informed consent signed

Exclusion criteria

Exclusion Criteria:

  • 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
  • Pregnancy
  • Missing of compliance
  • One or more missing post-extractive socket walls
  • Extraction of adjacent teeth in the 6 months following ARP
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Test group

    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. * Prosthetic Phase (10 Months): Four months after implant placement (allowing for proper osseointegration), the final prosthetic phase is carried out to restore the tooth.

    Procedure: Alveolar ridge preservation

Interventions

  • ProcedureAlveolar ridge preservation

    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.

    Also known as: Bone harvesting, Implant placement

05

What researchers measure

Primary outcomes

  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

    Time frame: perioperatively

Secondary outcomes

  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.

    Time frame: 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)

    Time frame: 1 year

06

Study locations

1 site
  • SC Clinica di Chirurgia Maxillofacciale e Odontostomatologia
    Trieste, Trieste 34100, Italy
07

References and documents

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 ↗
08

Registry details

Key details

Study ID
NCT07814092
Lead sponsor
International Piezosurgery Academy
Responsible party
Mr. Claudio Stacchi, DDS, MSc (Prof. Claudio Stacchi, International Piezosurgery Academy) — Principal investigator
First posted
Sep 10, 2026
Start date
Oct 1, 2025
Primary completion
Mar 1, 2027 (estimated)
Completion
Aug 1, 2027 (estimated)
Last update
Sep 10, 2026

Study contacts

Giulio Marchesi, DDS, MSc, PhD
study chair · Department of Medicine, Surgery and Health Sciences, University of Trieste, Italy
Claudio Stacchi, DDS, MSc
study chair · Department of Medicine and Surgery, LUM University, Casamassima (BA)

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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