Maxillary DeficiencyOD Vs ARSNCT06728202
Osseodensification Versus Alveolar Ridge Splitting
A study testing A Horizontal Ridge Augmentation in Atrophic Maxillary Ridge in people with Maxillary Deficiency and Horizontal Alveolar Bone Defect, run by Fayoum University.
Trial summary
Evaluation of clinical and radiological outcomes of the alveolar ridge splitting technique versus Osseodensification burs in atrophic maxillary alveolar ridges in horizontal dimension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Maxillary Deficiency, Horizontal Alveolar Bone Defect
- What is being tested?
- A Horizontal Ridge Augmentation in Atrophic Maxillary Ridge
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Dec 2024to Sep 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Mohammed Bahaa Khedr, Professor contact
About this study
Official title: A Horizontal Ridge Augmentation in Atrophic Maxillary Ridge: Evaluating Alveolar Ridge Splitting and Osseodensification
Evaluation of clinical and radiological outcomes of the alveolar ridge splitting technique versus Osseodensification burs in atrophic maxillary alveolar ridges in horizontal dimension.
Read the 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.
- 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.
- Being tested
- A Horizontal Ridge Augmentation in Atrophic Maxillary Ridge
- Keywords
- Osseodensification, Alveolar Ridge Splitting, Dental implant
- Medical subject headings
- Retrognathia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A Horizontal Ridge Augmentation in Atrophic Maxillary RidgeProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Alveolar ridge split group: | Active comparator | * a crestal incision and two vertical releasing incisions will be formed, followed by a full-thickness mucoperiosteal flap.
* the flap will be raised to expose the whole length facial cortical bone.
* The palatal mucoperiosteum will also be slightly reflected for better exposure of the crest of the alveolar ridge and free placement of the surgical guides.
* the patient specific guides will be placed and fixed by monocortical osteosynthesis screws at the pre-planned positions at the labial cortical plate of bone , precisely locate the mid-crestal and two vertical stop cuts to improve the accuracy of the procedure, preventing bad splits with the aim of reducing the final marginal bone loss associated with this technique.
* bony cut will be performed using a piezoelectric device on the facial aspect of alveolar ridge 1.5 mm away from the adjacent teeth or implants, extending 7 mm apically from the crest of the ridge.implants will be inserted in the osteotomy sites using torque-wrench Receives: Procedure: A Horizontal Ridge Augmentation in Atrophic Maxillary Ridge |
| Implant placement in pristine bone with Osseodensification burs group: | Active comparator | * A crestal incision and two vertical releasing incisions will be formed, followed by a full-thickness mucoperiosteal flap
* Implant osteotomies are being performed with the assistance of saline irrigation. The osteotomies will be performed at 800-1500 rpm in a counterclockwise direction (Densifying Mode) with the use of sequential burs of similar diameter (OD drilling burs) used with copious irrigation in a Bouncing-Pumping motion (minor vertical pressure to advance the drill into the osteotomy, then pull out for pressure relief, then advance with vertical pressure again and so on in an in/out fashion). the instrumentation will be performed according to the recommended drilling protocols for Densah® Burs implant system; either by standard drilling, as recommended by implant company protocols.
* The insertion of the implants will be initiated with the motor handpiece, without irrigation at 20-50 rpm, and installation will be completed with a manual surgical torque wrench Receives: Procedure: A Horizontal Ridge Augmentation in Atrophic Maxillary Ridge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gained bone width :
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.
Measured: preoperative , immediate postoperative and 6 months postoperative.
Secondary outcomes (2)
Bone density :
CBCT to measure difference in bone density of newly formed bone at implant-crestal margin using the gray scale.
Measured: Immediate post operative and 6 months postoperative
primary stability:
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.
Measured: immediately and 6 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study startDec 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- 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) .
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Wesam Saied Sayed, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06728202
- Sponsor's protocol ID
- Horizontal Ridge Augmentation
- Acronym
- OD Vs ARS
- Status last verified
- Dec 2024
- First submitted
- 6 Dec 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Horizontal Ridge Augmentation in Atrophic Maxillary Ridge: Evaluating Alveolar Ridge Splitting and Osseodensification
- ClinicalTrials.gov ID
- NCT06728202
- Acronym / sponsor ID
- OD Vs ARS / Horizontal Ridge Augmentation
- Keywords
- Osseodensification, Alveolar Ridge Splitting, Dental implant
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 11 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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) .
| Arm | Type | Receives |
|---|---|---|
| Alveolar ridge split group: | Active comparator | Procedure: A Horizontal Ridge Augmentation in Atrophic Maxillary Ridge* a crestal incision and two vertical releasing incisions will be formed, followed by a full-thickness mucoperiosteal flap. * the flap will be raised to expose the whole length facial cortical bone. * The palatal mucoperiosteum will also be slightly reflected for better exposure of the crest of the alveolar ridge and free placement of the surgical guides. * the patient specific guides will be placed and fixed by monocortical osteosynthesis screws at the pre-planned positions at the labial cortical plate of bone , precisely locate the mid-crestal and two vertical stop cuts to improve the accuracy of the procedure, preventing bad splits with the aim of reducing the final marginal bone loss associated with this technique. * bony cut will be performed using a piezoelectric device on the facial aspect of alveolar ridge 1.5 mm away from the adjacent teeth or implants, extending 7 mm apically from the crest of the ridge.implants will be inserted in the osteotomy sites using torque-wrench |
| Implant placement in pristine bone with Osseodensification burs group: | Active comparator | Procedure: A Horizontal Ridge Augmentation in Atrophic Maxillary Ridge* A crestal incision and two vertical releasing incisions will be formed, followed by a full-thickness mucoperiosteal flap * Implant osteotomies are being performed with the assistance of saline irrigation. The osteotomies will be performed at 800-1500 rpm in a counterclockwise direction (Densifying Mode) with the use of sequential burs of similar diameter (OD drilling burs) used with copious irrigation in a Bouncing-Pumping motion (minor vertical pressure to advance the drill into the osteotomy, then pull out for pressure relief, then advance with vertical pressure again and so on in an in/out fashion). the instrumentation will be performed according to the recommended drilling protocols for Densah® Burs implant system; either by standard drilling, as recommended by implant company protocols. * The insertion of the implants will be initiated with the motor handpiece, without irrigation at 20-50 rpm, and installation will be completed with a manual surgical torque wrench |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A Horizontal Ridge Augmentation in Atrophic Maxillary RidgeAiming to enhance bone volume (Quantity) in horizontal maxillary bone defects and density (Quality) , providing a viable solution for implant stability and long-term success. | Procedure or surgery | Alveolar ridge split group:, Implant placement in pristine bone with Osseodensification burs group: |
Primary outcome
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: 1. Ridge width (RW): the distance between the buccal and palatal border of the bone at the crest. 2. 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.
2 secondary outcomes
Bone density :
Time frame: Immediate post operative and 6 months postoperative
primary stability:
Time frame: immediately and 6 months post-operative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Maxillary Deficiency
Active, not recruitingObservational study
Long-Term Stability of Soft and Hard Tissues After Guided Bone Regeneration in the Maxillary Anterior Region
Alveolar Bone Deficiency
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Three-Dimensional Facial Soft Tissue Changes and Clinical Perception Following MARPE
Maxillary Transverse Deficiency
Active, not recruitingObservational study
Evaluation of Bone Regeneration Outcomes Following Guided Bone Regeneration in the Anterior Maxillary Region
Implant Placement in Maxillary Esthetic Zone
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Tooth-Borne (TBA) Versus Hybrid Expanders (HA) in Surgically Assisted Rapid Maxillary Expansion (SARME)
Maxillary Transverse Deficiency
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Maxillary Transverse Deficiency, Rapid Maxillary Expansion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohammed Bahaa Khedr, Professor contact
Questions about this trial
What is this clinical trial studying?
A study testing A Horizontal Ridge Augmentation in Atrophic Maxillary Ridge in people with Maxillary Deficiency and Horizontal Alveolar Bone Defect, run by Fayoum University.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Islam Wesam Saied Sayed (+201006657280, iw1130@fayoum.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gained bone width : (time frame: preoperative , immediate postoperative and 6 months postoperative.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Dec 2024.