OsseodensificationNCT05569564
Evaluation of Osseodensification Versus Osseodensification With Ridge Splitting in Horizontally Deficient Ridge
A study testing Ridge splitting followed by ossedensificaion and Osseodensification in people with Osseodensification, run by Ain Shams University.
Trial summary
Osseodensification is a method of biomechanical bone preparation where specially designed burs increase density of bone as they expand an osteotomy. These osseodensifying burs combine advantages of osteotome bone preservation with the standard traditional drilling burs speed and tactile control. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Osseodensification
- What is being tested?
- Ridge splitting followed by ossedensificaion and Osseodensification
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients suffering from missing single or multiple maxillay anterior and /or premolar with at least 8 mm alveolar ridge height, with 4-6mm alveolar buccolingual (BL) ridge width.
- Patients should be systemically healthy.
- Patients available during follow up periods.
Who cannot join
- Pregnant females.
- Smokers.
- Poor oral hygiene.
- Vulnerable patients
Trial locations and contacts
No sites are listed yet.
Yasmine E. Fouad, Lecturer contact
About this study
Official title: Evaluation of Osseodensification Versus Osseodensification With Ridge Splitting in Horizontally Deficient Ridge (A Randomized Clinical Study)
Osseodensification is a method of biomechanical bone preparation where specially designed burs increase density of bone as they expand an osteotomy. These osseodensifying burs combine advantages of osteotome bone preservation with the standard traditional drilling burs speed and tactile control. The investigators compared ridge splitting followed by osseodensification versus osseodensification in terms of buccolingual ridge expansion both clinically and radiographically.
Read the detailed description
Sixteen patients will be randomly allocated into two groups. Ridge splitting followed by osseodensification will be performed with simultaneous implant placement in group I.
Osseodensification will be performed with simultaneous implant placement in group II.
Alveolar ridge width and Implant stability will be assessed clinically. Alveolar ridge width and bone density will be assessed radiographically.
- Conditions
- Osseodensification
- Being tested
- Ridge splitting followed by ossedensificaion, Osseodensification
- Keywords
- Osseodensification, Alveolar ridge splitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ridge splitting followed by ossedensificaionProcedure or surgery
Ridge splitting followed by ossedensificaion with osseodensifying burs.
OsseodensificationProcedure or surgery
Pilot drill is used to make the initial osteotomy to the desired depth, then osseodensifying burs will be used in sequence, gradually wider diameter in a counterclockwise rotation and bouncing motion under profuse saline irrigation
| Study group | Role | What they receive |
|---|---|---|
| Osseodensification with ridge splitting | Experimental | Ridge splitting followed by osseodensification using osseodensifying burs . Receives: Procedure: Ridge splitting followed by ossedensificaion; Procedure: Osseodensification |
| Osseodensification | Active comparator | osseodensification will be performed using osseodensifying burs. Receives: Procedure: Osseodensification |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of gain in alveolar ridge width
Radiographically
Measured: before surgery and immediately after surgery
Secondary outcomes (2)
primary implant stability
Implant stability quotient measured by ostell
Measured: at the end of surgery
bone density
radiographically
Measured: before surgery and immediately after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start1 Oct 2022 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsseodensificationStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Farouk Mohamed Hussein Elsobky, Ain Shams University
- Investigators
- Nevine H. El Din, Professor, Study director, Faculty of Dentistry, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05569564
- Sponsor's protocol ID
- FDASU-Rec ID032211
- Status last verified
- Oct 2022
- First submitted
- 29 Sep 2022
- Last updated
- 6 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Osseodensification Versus Osseodensification With Ridge Splitting in Horizontally Deficient Ridge (A Randomized Clinical Study)
- ClinicalTrials.gov ID
- NCT05569564
- Acronym / sponsor ID
- FDASU-Rec ID032211
- Conditions
- Osseodensification
- Keywords
- Osseodensification, Alveolar ridge splitting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 6 Oct 2022 (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.
Osseodensification is a method of biomechanical bone preparation where specially designed burs increase density of bone as they expand an osteotomy. These osseodensifying burs combine advantages of osteotome bone preservation with the standard traditional drilling burs speed and tactile control. The investigators compared ridge splitting followed by osseodensification versus osseodensification in terms of buccolingual ridge expansion both clinically and radiographically.
Detailed description
Sixteen patients will be randomly allocated into two groups. Ridge splitting followed by osseodensification will be performed with simultaneous implant placement in group I.
Osseodensification will be performed with simultaneous implant placement in group II.
Alveolar ridge width and Implant stability will be assessed clinically. Alveolar ridge width and bone density will be assessed radiographically.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osseodensification with ridge splitting | Experimental | Procedure: Ridge splitting followed by ossedensificaion, Procedure: OsseodensificationRidge splitting followed by osseodensification using osseodensifying burs . |
| Osseodensification | Active comparator | Procedure: Osseodensificationosseodensification will be performed using osseodensifying burs. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients suffering from missing single or multiple maxillay anterior and /or premolar with at least 8 mm alveolar ridge height, with 4-6mm alveolar buccolingual (BL) ridge width.
- Patients should be systemically healthy.
- Patients available during follow up periods.
Key exclusion criteria (4 listed)
- Pregnant females.
- Smokers.
- Poor oral hygiene.
- Vulnerable patients
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 |
|---|---|---|
| Ridge splitting followed by ossedensificaionRidge splitting followed by ossedensificaion with osseodensifying burs. | Procedure or surgery | Osseodensification with ridge splitting |
| OsseodensificationPilot drill is used to make the initial osteotomy to the desired depth, then osseodensifying burs will be used in sequence, gradually wider diameter in a counterclockwise rotation and bouncing motion under profuse saline irrigation | Procedure or surgery | Osseodensification, Osseodensification with ridge splitting |
Primary outcome
assessment of gain in alveolar ridge width
Time frame: before surgery and immediately after surgery
Radiographically
2 secondary outcomes
primary implant stability
Time frame: at the end of surgery
bone density
Time frame: before surgery and immediately after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
- Individual participant dataSharing planned: No
Related trials for Osseodensification
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Effectiveness of Clockwise vs. Counter-Clockwise Osseodensification for Implant Site Preparation
Osseodensification Drilling Technique
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"Osseodensification Efficacy on Molar Septum Expansion in Immediate Molar Implant Placement
Implant Osseointegration, Implant Osteotomy
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Two-Stage Transcrestal Sinus Lift With Osseodensification: Allograft vs Autogenous-Xenograft
Severely Atrophic Posterior Maxilla
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Osseodensification for Narrow Alveolar Ridge Expansion
Osseodensification, Bone Expansion
Enrolling by invitation
Implant Stability Outcomes Following Immediate Implant Placement Using Osseodensification Versus Conventional Drilling
Immediate Dental Implant Placement, Lower Molar Requiring Extraction
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. This study is not recruiting at the moment.
Yasmine E. Fouad, Lecturer contact
Nevine H. El Din, Professor study director
Faculty of Dentistry, Ain Shams University
Questions about this trial
What is this clinical trial studying?
A study testing Ridge splitting followed by ossedensificaion and Osseodensification in people with Osseodensification, run by Ain Shams 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 6 Oct 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eman F. Elsobky, Ass.lecturer (01277399336, emanfarouk@dent.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of gain in alveolar ridge width (time frame: before surgery and immediately after surgery). 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 6 Oct 2022.