Edentulous Alveolar RidgeNCT05141331
Comparison of Piezoelectric Split-crest Technique Versus Expansion Using Hand Driven Ridge Expanders in Treatment of Maxillary Narrow Ridges
A study testing piezoelectric in people with Edentulous Alveolar Ridge, run by ahmed ashraf abdelreheem at 1 site in Egypt.
Trial summary
Comparison of Piezoelectric split-crest technique versus expansion using Hand Driven Ridge Expanders in treatment of Maxillary Narrow Ridges Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Edentulous Alveolar Ridge
- What is being tested?
- piezoelectric
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 20 May 2021to Jul 2022
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants are free from any systemic diseases.
- Participant have missing one or two premolars or molars with sufficient alveolar ridge height and insufficient alveolar ridge buccolingual (BL) width that interfere with conventional straight forward implant placement.
- The minimum BL ridge width included in the study will be 3.5 mm to facilitate ridge splitting and expansion
Who cannot join
- Patients with residual infections in the edentulous areas.
- Medically compromised groups.
- Smokers and patients with poor oral hygiene.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Giza
ahmed ashraf, 01100087668, dr.aashraf9@gmail.com
About this study
Comparison of Piezoelectric split-crest technique versus expansion using Hand Driven Ridge Expanders in treatment of Maxillary Narrow Ridges
- Conditions
- Edentulous Alveolar Ridge
- Being tested
- piezoelectric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
piezoelectricDevice
Comparing Piezoelectric split-crest technique versus expansion using Hand Driven Ridge Expanders in treatment of Maxillary Narrow Ridges
| Study group | Role | What they receive |
|---|---|---|
| Piezoelectric split-crest technique in treatment of Maxillary Narrow Ridges | Experimental | Piezoelectric split-crest technique in treatment of Maxillary Narrow Ridges Receives: Device: piezoelectric |
| Hand Driven Ridge Expanders in treatment of Maxillary Narrow Ridges | Active comparator | Hand Driven Ridge Expanders in treatment of Maxillary Narrow Ridges Receives: Device: piezoelectric |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone width
bone width gain in millimeters
Measured: 5 months
Secondary outcomes (1)
implant stability
implant stability measured with periotest
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start20 May 2021
- Primary completionMay 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous Alveolar RidgeStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ahmed ashraf abdelreheem
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ahmed ashraf abdelreheem, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05141331
- Sponsor's protocol ID
- 27721
- Status last verified
- Dec 2021
- First submitted
- 19 Nov 2021
- Last updated
- 3 Dec 2021
- 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 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Piezoelectric Split-crest Technique Versus Expansion Using Hand Driven Ridge Expanders in Treatment of Maxillary Narrow Ridges
- ClinicalTrials.gov ID
- NCT05141331
- Acronym / sponsor ID
- 27721
- Conditions
- Edentulous Alveolar Ridge
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- ahmed ashraf abdelreheemUniversity, hospital or other
- Study start
- 20 May 2021 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 2 Dec 2021 (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.
Comparison of Piezoelectric split-crest technique versus expansion using Hand Driven Ridge Expanders in treatment of Maxillary Narrow Ridges
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Piezoelectric split-crest technique in treatment of Maxillary Narrow Ridges | Experimental | Device: piezoelectricPiezoelectric split-crest technique in treatment of Maxillary Narrow Ridges |
| Hand Driven Ridge Expanders in treatment of Maxillary Narrow Ridges | Active comparator | Device: piezoelectricHand Driven Ridge Expanders in treatment of Maxillary Narrow Ridges |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants are free from any systemic diseases.
- Participant have missing one or two premolars or molars with sufficient alveolar ridge height and insufficient alveolar ridge buccolingual (BL) width that interfere with conventional straight forward implant placement.
- The minimum BL ridge width included in the study will be 3.5 mm to facilitate ridge splitting and expansion
Key exclusion criteria (3 listed)
- Patients with residual infections in the edentulous areas.
- Medically compromised groups.
- Smokers and patients with poor oral hygiene.
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 |
|---|---|---|
| piezoelectricComparing Piezoelectric split-crest technique versus expansion using Hand Driven Ridge Expanders in treatment of Maxillary Narrow Ridges | Device | Hand Driven Ridge Expanders in treatment of Maxillary Narrow Ridges, Piezoelectric split-crest technique in treatment of Maxillary Narrow Ridges |
Primary outcome
bone width
Time frame: 5 months
bone width gain in millimeters
1 secondary outcome
implant stability
Time frame: 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2021.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing piezoelectric in people with Edentulous Alveolar Ridge, run by ahmed ashraf abdelreheem 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 3 inclusion and 3 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 3 Dec 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bone width (time frame: 5 months). 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 3 Dec 2021.