Alveolar Process AtrophyNCT05685576
Evaluation of a Combined Ridge Expansion Technique With Simultaneous Dental Implant Placement
A study testing Piezotomed ridge splitting and osseodensification in people with Alveolar Process Atrophy, run by Lydia Nabil at 1 site in Egypt.
Trial summary
Patients with long span, narrow edentulous ridge in the posterior mandible underwent piezotomed ridge splitting and osseodensification with simultaneous implant placement. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Alveolar Process Atrophy
- What is being tested?
- Piezotomed ridge splitting and osseodensification
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Mar 2022to 5 Mar 2023
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with good oral hygiene
- Patients with long-span, narrow posterior edentulous mandibular area
- Age limit range [25 - 66 years]
- Patients who accept to participate in the study
- Minimum height 10mm from the crest of the ridge till the upper border of inferior alveolar canal
- Minimum ridge thickness = 3mm at the crestal region
- If the patient is diabetic, should be controlled.
Who cannot join
- Immunosuppressive/ autoimmune disease patients
- Patients with osteoporosis
- Lack of sufficient amount of keratinizing mucosa at the crest of the edentulous saddle
- Patients with bleeding disorder disease
- Ridge width less than 3 mm
- Smokers
- Patients having periodontal disease
- The presence of a pathological lesion in the area of ridge splitting
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Combined Ridge Expansion Technique With Simultaneous Dental Implant Placement in Narrow Posterior Mandible
Patients with long span, narrow edentulous ridge in the posterior mandible underwent piezotomed ridge splitting and osseodensification with simultaneous implant placement.
Read the detailed description
This study is a single arm clinical trial. Patients of both genders, who are indicated for ridge splitting, were recruited from the outpatient clinic, Faculty of dentistry, Alexandria University.
The PICO question: "What is the effect of piezotomed ridge splitting and osseodensification on implant placement in narrow posterior mandibular ridges?"
Ethical approval for the study was obtained from the regional Ethical Review Board of the Faculty of Dentistry. All patients were informed about the procedure details, and each participant signed a written consent.
Ridge expansion was accomplished by piezotomed ridge splitting and osseodensification. Simultaneous implant placement was done in the same procedure.
Implant stability was assessed. Also, bone width gained and bone density were measured around the dental implants using cone beam computed tomography.
- Conditions
- Alveolar Process Atrophy
- Being tested
- Piezotomed ridge splitting and osseodensification
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piezotomed ridge splitting and osseodensificationDevice
Ridge expansion using piezotomed ridge splitting and osseodensification
| Study group | Role | What they receive |
|---|---|---|
| Ridge splitting and osseodensification with simultaneous implant placement | Experimental | Not described Receives: Device: Piezotomed ridge splitting and osseodensification |
What is being measured
The primary outcome is the main question the study is designed to answer.
The score of primary implant stability
- Primary stability of the implants is measured using:
- insertion torque and
- resonance frequency analysis by Osstell ISQ device (Osstell ISQ, W\&H, Sweden)
Measured: immediately at time of implant insertion
Secondary outcomes (2)
The width of bone gained
Width of bone gained at the crest of the ridge is measured by cone beam computed tomography in mm
Measured: 3 months postoperative
The mean bone density around dental implants
The mean bone density around dental implants is measured by cone beam computed tomography in grey scale values
Measured: 3 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start25 Mar 2022
- Primary completion4 Mar 2023
- Study completion5 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Process AtrophyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lydia Nabil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lydia Nabil, University of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05685576
- Sponsor's protocol ID
- UAlexandriaDentSurg22
- Status last verified
- May 2023
- First submitted
- 4 Jan 2023
- Last updated
- 9 May 2023
- Results posted
- No
- 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 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Combined Ridge Expansion Technique With Simultaneous Dental Implant Placement in Narrow Posterior Mandible
- ClinicalTrials.gov ID
- NCT05685576
- Acronym / sponsor ID
- UAlexandriaDentSurg22
- Conditions
- Alveolar Process Atrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Lydia NabilUniversity, hospital or other
- Study start
- 25 Mar 2022 (actual)
- Primary completion
- 4 Mar 2023 (actual)
- Study completion
- 5 Mar 2023 (actual)
- First posted
- 17 Jan 2023 (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.
Patients with long span, narrow edentulous ridge in the posterior mandible underwent piezotomed ridge splitting and osseodensification with simultaneous implant placement.
Detailed description
This study is a single arm clinical trial. Patients of both genders, who are indicated for ridge splitting, were recruited from the outpatient clinic, Faculty of dentistry, Alexandria University.
The PICO question: "What is the effect of piezotomed ridge splitting and osseodensification on implant placement in narrow posterior mandibular ridges?"
Ethical approval for the study was obtained from the regional Ethical Review Board of the Faculty of Dentistry. All patients were informed about the procedure details, and each participant signed a written consent.
Ridge expansion was accomplished by piezotomed ridge splitting and osseodensification. Simultaneous implant placement was done in the same procedure.
Implant stability was assessed. Also, bone width gained and bone density were measured around the dental implants using cone beam computed tomography.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ridge splitting and osseodensification with simultaneous implant placement | Experimental | Device: Piezotomed ridge splitting and osseodensification |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with good oral hygiene
- Patients with long-span, narrow posterior edentulous mandibular area
- Age limit range [25 - 66 years]
- Patients who accept to participate in the study
- Minimum height 10mm from the crest of the ridge till the upper border of inferior alveolar canal
Key exclusion criteria (8 listed)
- Immunosuppressive/ autoimmune disease patients
- Patients with osteoporosis
- Lack of sufficient amount of keratinizing mucosa at the crest of the edentulous saddle
- Patients with bleeding disorder disease
- Ridge width less than 3 mm
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 |
|---|---|---|
| Piezotomed ridge splitting and osseodensificationRidge expansion using piezotomed ridge splitting and osseodensification | Device | Ridge splitting and osseodensification with simultaneous implant placement |
Primary outcome
The score of primary implant stability
Time frame: immediately at time of implant insertion
- Primary stability of the implants is measured using: * insertion torque and * resonance frequency analysis by Osstell ISQ device (Osstell ISQ, W\&H, Sweden)
2 secondary outcomes
The width of bone gained
Time frame: 3 months postoperative
The mean bone density around dental implants
Time frame: 3 months postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Individual participant dataSharing planned: No
Related trials for Alveolar Process Atrophy
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Peri-implantitis, Alveolar Bone Loss
Recruiting
Two Bovine Xenografts in Lateral Window Sinus Augmentation With or Without Bone Marrow Blood
Alveolar Bone Loss, Sinus Floor Augmentation
Recruiting
The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
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Enrolling by invitation
Investigation of the Effect of Horizontal Platelet Rich Fibrin Placed in Tooth Extraction Sockets on Bone Formation
Tooth Loss, Dental Implant Failed
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Piezotomed ridge splitting and osseodensification in people with Alveolar Process Atrophy, run by Lydia Nabil at 1 site in Egypt.
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 7 inclusion and 8 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: finished, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The score of primary implant stability (time frame: immediately at time of implant insertion). 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 9 May 2023.