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

NCT07814092 | Enrolling By Invitation DMC

• 1 other identifier: Units 09/2024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alveolar Bone Preservation

Keywords

Alveolar ridge preservation; Radiomics; Post-extractive bone remodeling

Outcome Measures

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

  perioperatively

Secondary Outcomes (2)

• Histomorphometric values

  periprocedural

• Implant survival

  1 year

Study Arms (1)

Test group

EXPERIMENTAL

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

Alveolar ridge preservation PROCEDURE

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

Test group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• International Piezosurgery Academy: lead

Study Sites (1)

SC Clinica di Chirurgia Maxillofacciale e Odontostomatologia

Trieste, Trieste, 34100, Italy

Location

Related Publications (4)

• 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.

  PMID: 36843362 RESULT

• 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.

  PMID: 32060219 RESULT

• 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.

  PMID: 32785796 RESULT

• 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.

  PMID: 32233185 RESULT

Study Officials

• Giulio Marchesi, DDS, MSc, PhD

  Department of Medicine, Surgery and Health Sciences, University of Trieste, Italy

  STUDY CHAIR

• Claudio Stacchi, DDS, MSc

  Department of Medicine and Surgery, LUM University, Casamassima (BA)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Claudio Stacchi

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: September 10, 2026
• Study Start: October 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: September 10, 2026

Record last verified: 2026-09

Locations

IT (1)