Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06728202

Osseodensification Versus Alveolar Ridge Splitting

Evaluation of clinical and radiological outcomes of the alveolar ridge splitting technique versus Osseodensification burs in atrophic maxillary alveolar ridges in horizontal dimension.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

About this study

The success of dental implant procedures hinges not only on the expertise of the clinician but also on the quality and quantity of bone at the implant site.

The significance of bone parameters in determining the feasibility and long-term outcomes of dental implants cannot be overstated. Over the years, various classifications have been proposed to assess bone quality and quantity, each aiming to provide a comprehensive framework for clinicians to evaluate and plan implant placement effectively.

One of the seminal classifications widely utilized in clinical practice is (the Cawood and Howell classification)1,2,3, which categorizes edentulous ridges into six types based on the quantity and quality of residual bone. In this classification system class IV in maxilla has gained special interest as it provides the adequate length for implant insertion but the width is insufficient. That made lots of researchers come with lots of different solutions to save time,cost and provide the best results for the patient.

Computed tomography (CT) provides an objective means to quantify bone density, expressed in Hounsfield units (HU), as described by T. Misch. The HU derived from CBCT scans correspond to grayscale values. Through linear regression analysis, grayscale values can be subjectively determined from CBCT images by aligning CT images with the same points on CBCT scans. The regression equation used for this analysis was HU = -61.098 + 1.178 × grayscale.4,5,6,7,8

Horizontal bone defects pose significant challenges in dental implantology, often requiring innovative surgical techniques to achieve successful implant placement.

Two emerging approaches, alveolar ridge splitting and osseodensification with specialized burs, have garnered attention for their potential in addressing such defects. These techniques aim to enhance bone volume (Quantity) and density (Quality) , providing a viable solution for implant stability and long term success.

  • Alveolar Ridge Splitting (ARST) :

Alveolar ridge splitting, also known as horizontal or crestal osteotomy, is a surgical technique designed to increase the width of the alveolar ridge in cases of horizontal bone deficiency.

The procedure involves carefully dividing the ridge and expanding it to create space for implant placement. Numerous studies have demonstrated the efficacy of ridge splitting in augmenting bone volume horizontally, allowing for the successful insertion of dental implants (Bassetti MA et al.2016)9.

In a systematic review by Bassetti MA et al.2016 , alveolar ridge splitting was employed in patients with severe horizontal atrophy in the maxilla. The results indicated successful bone augmentation, with improved implant stability and survival rate.

The technique exhibited minimal postoperative complications and demonstrated its potential as a reliable method for addressing maxillary horizontal bone defects.

The ARST technique, by expanding buccal bone, prevents the dispersion of particulate bone substitutes and offers mechanical support against buccal mucosal tension. The expanded buccal bone also contains osteogenic stem cells and growth factors, potentially enhancing soft tissue healing and bone formation according to (Zhang L, Huang et al.2020)10 The systematic review conducted by (Elnayef B, Monje A et al.2015)11 and (Lin Y,Li G et al.2023)12 concluded that ARS technique: Predictable with high implant survival rate, adequate bone gain, and minimal complications and The weighted mean of horizontal bone width gain for full thickness flap ARS: 3.19 ± 1.19 mm (range: 2.00 to 4.03 mm)

  • Osseodensification Burs (OD) :

Osseodensification drilling protocol shows promise in cases of poor-quality autologous bone or challenging anatomical areas for implant stability. However, literature is limited, mainly comprising animal studies and short-term clinical cases. The technique's innovative nature necessitates specialized training for effective utilization according to (Inchingolo, A.D. et al.2021)13 Systematic Review. A study conducted by (Bergamo ETP et al., 2021)14 investigated the use of osseodensification burs in a series of cases involving maxillary horizontal bone atrophy. The results demonstrated improved primary implant stability and accelerated bone healing compared to traditional drilling techniques. Osseodensification not only addressed the bone defect but also facilitated faster osseointegration, contributing to successful implant outcomes.

A study conducted by (Koutouzis T et al., 2019)15 shows that the ridge dimensional percentage increase may reach up to 75% expansion in (3-4 mm) ridge width group.

Osseodensification not only addressed the bone atrophy, but also facilitated faster osseointegration, contributing to successful implant outcomes.x So Alveolar ridge splitting and osseodensification burs present promising solutions for maxillary horizontal bone defects, offering enhanced bone volume, density, and implant stability. Integrating these techniques into the treatment arsenal for implantology may provide clinicians with effective strategies to overcome the challenges posed by horizontal bone deficiencies in the maxilla.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

I. Patients with atrophic maxillary alveolar ridges in horizontal dimension <18 years old. II. the bucco-palatal alveolar ridge dimension 2-4 mm III. a minimal vertical bone height of 10 mm

Exclusion criteria

I. Bad oral hygiene. II. Patients with non healthy habits as (Smokers, Alcoholics, or drug abusers). III. Patients with any active periapical pathosis. IV. Patients treated with chemo or radiotherapy during the past 5 years. V. Acute and progressive periodontal disease. VI. Medically compromised patient not indicated for surgical procedures. VII. Patient with history of bleeding disorders. VIII. Patient with osteo-porotic disease.

Treatment and study plan

A Horizontal Ridge Augmentation in Atrophic Maxillary Ridge

Procedure

Aiming to enhance bone volume (Quantity) in horizontal maxillary bone defects and density (Quality) , providing a viable solution for implant stability and long-term success.

Primary outcomes

  1. Gained bone width :

    Time frame: preoperative , immediate postoperative and 6 months postoperative.

    will be measured immediately after surgery by CBCT using the following reference points:

    • Ridge width (RW): the distance between the buccal and palatal border of the bone at the crest.
    • Buccal bone thickness (BBT): the distance from the implant surface to the outer margin of bone. All variables will be measured twice with an interval of 1 week between measurements.

Secondary outcomes

  1. Bone density :

    Time frame: Immediate post operative and 6 months postoperative

    CBCT to measure difference in bone density of newly formed bone at implant-crestal margin using the gray scale.

  2. primary stability:

    Time frame: immediately and 6 months post-operative

    we measure using insertion Smartpeg specific for the implant system and restorative platform diameter will be used for each implant and perform a resonance frequency analysis using an OsstellMentor device18 (Ostell/Integration Diagnostics,Gothenburg, Sweden) to record ISQ19 values in all implant surfaces.

Study contacts

Contact information is provided by the study sponsor or research team.

Islam Wesam Saied Sayed

CONTACT

[email protected]

+201006657280

Mohammed Bahaa Khedr, Professor

CONTACT

+201061159076

Sponsors and collaborators

Lead sponsor

Fayoum University

Other

Registry information

Official study title

A Horizontal Ridge Augmentation in Atrophic Maxillary Ridge: Evaluating Alveolar Ridge Splitting and Osseodensification

Acronym: OD Vs ARS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 11, 2024
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.