Clinical trial NCT06728202: Osseodensification Versus Alveolar Ridge Splitting
Official title: A Horizontal Ridge Augmentation in Atrophic Maxillary Ridge: Evaluating Alveolar Ridge Splitting and Osseodensification
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Maxillary Deficiency
Horizontal Alveolar Bone Defect
Keywords: Osseodensification
Alveolar Ridge Splitting
Dental implant
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective randomized (1:1) clinical trial study formed of 2 competitive groups where 46 implants will be placed in 2 groups (23 for each group) to compare the Gained bone width in patients with atrophic maxillae (Horizontal defect) .
Primary purpose: TREATMENT

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

Detailed description: 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.

1. 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)
2. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Gained bone width :
timeFrame: preoperative , immediate postoperative and 6 months postoperative.
Secondary outcomes:
measure: Bone density :
timeFrame: Immediate post operative and 6 months postoperative
measure: primary stability:
timeFrame: immediately and 6 months post-operative
Other outcomes:
Locations:
Study officials:
References: