Dental Implant FailedNCT06294171
Efficacy of Modified Piezosurgery Alveolar Bone Cut With Osseodensification Drills in Expanding Narrow Alveolar Bone
A study testing measurement of alveolar ridge width in people with Dental Implant Failed, run by University of Baghdad at 1 site in Iraq.
Trial summary
The aim of the study is to determine the efficacy of modified piezosurgery with osseodensification drills in expanding narrow alveolar bone. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implant Failed
- What is being tested?
- measurement of alveolar ridge width
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteIraq
- Study dates
- 15 Nov 2022to 1 Nov 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient's age ≥18 years.
- Absence of any medical disease that compromise wound healing.
- Patient with good oral hygiene.
- Narrow alveolar bone (3-4 mm) with minimum alveolar bone height of (12 mm).
Who cannot join
- Uncontrolled medically compromised patients.
- Heavy smokers (> 10 cigarettes per day).
- Patient with parafunctional habits.
- Local infection at implant site.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Modified Piezosurgery Alveolar Bone Cut With Osseodensification Drills in Expanding Narrow Alveolar Bone (Randomized Clinical Trial)
The aim of the study is to determine the efficacy of modified piezosurgery with osseodensification drills in expanding narrow alveolar bone.
Read the detailed description
Atrophic maxilla or mandible can lead to lack of prosthesis retention because of an inadequate bearing area causing both functional and physiological problems for patient, these problems can be treated for patient satisfaction with an implant supported fixed or removable complete or partial denture. Atrophic edentulous jaws can represent a significant challenge to the successful use of endosseous implants for prosthetic reconstruction of the edentulous mandible.
A collapsed alveolar ridge demonstrating a narrow width (less than 5 mm in many cases) and grossly adequate alveolar height is the most common candidate for the RSP.
Beginners in RSP should initially choose a 4-5 mm thickness of an even maxillary alveolar ridge and strive to almost double it in width.
A 3-mm alveolar ridge generally consists of 3 thin bone layers (in a horizontal sandwich fashion): 2 cortical plates (about 1 mm each) separated by 1 cancellous layer (about 1 mm). The wider the cancellous bone layer (the layer where the split is done), the easier it will be to accomplish the RSP
- Conditions
- Dental Implant Failed
- Being tested
- measurement of alveolar ridge width
- Keywords
- peizosurgery , osseodensification , modified ridge splitting , dental implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measurement of alveolar ridge widthDevice
the surgical procedure started with envelop flap reflection. A mucoperiosteal elevator was used to reflect the buccal and palatal flaps that were enough to expose the crestal part of alveolar ridge with clear visibility and accessibility. Measuring the width of the alveolar ridge 1 mm below the crest using bone caliber. Using piezoelectric surgery unit (Piezosurgery Ultrasonic® mectron, Italy), a horizontal crestal cut was produced along the crest of the bone. The cut depth extended into the same depth of the final dental implant to be inserted and then Versah Drills will be used in a successive manner and under copious irrigation with chilled sterile normal saline.We will measure the rate of ridge expansion by bone caliber to determine the efficacy of combining Versah drills with piezo surgery in expanding narrow alveolar bone.
| Study group | Role | What they receive |
|---|---|---|
| measurement of alveolar ridge width | Other | the surgical procedure started with envelop flap reflection. A mucoperiosteal elevator was used to reflect the buccal and palatal flaps that were enough to expose the crestal part of alveolar ridge with clear visibility and accessibility. Measuring the width of the alveolar ridge 1 mm below the crest using bone caliber. Using piezoelectric surgery unit (Piezosurgery Ultrasonic® mectron, Italy), a horizontal crestal cut was produced along the crest of the bone. The cut depth extended into the same depth of the final dental implant to be inserted and then Versah Drills will be used in a successive manner and under copious irrigation with chilled sterile normal saline.We will measure the rate of ridge expansion by bone caliber to determine the efficacy of combining Versah drills with piezo surgery in expanding narrow alveolar bone. Receives: Device: measurement of alveolar ridge width |
What is being measured
The primary outcome is the main question the study is designed to answer.
expansion rate
by digital vernier
Measured: immediately
expansion rate
by digital vernier
Measured: after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start15 Nov 2022
- Primary completion1 May 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Implant FailedStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amjed Kadhim Tayyeh, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06294171
- Sponsor's protocol ID
- Modified Alveolar Bone Cut
- Status last verified
- Feb 2024
- First submitted
- 27 Feb 2024
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It will be mostly available on request.
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Modified Piezosurgery Alveolar Bone Cut With Osseodensification Drills in Expanding Narrow Alveolar Bone (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT06294171
- Acronym / sponsor ID
- Modified Alveolar Bone Cut
- Conditions
- Dental Implant Failed
- Keywords
- peizosurgery , osseodensification , modified ridge splitting , dental implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 5 Mar 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.
The aim of the study is to determine the efficacy of modified piezosurgery with osseodensification drills in expanding narrow alveolar bone.
Detailed description
Atrophic maxilla or mandible can lead to lack of prosthesis retention because of an inadequate bearing area causing both functional and physiological problems for patient, these problems can be treated for patient satisfaction with an implant supported fixed or removable complete or partial denture. Atrophic edentulous jaws can represent a significant challenge to the successful use of endosseous implants for prosthetic reconstruction of the edentulous mandible.
A collapsed alveolar ridge demonstrating a narrow width (less than 5 mm in many cases) and grossly adequate alveolar height is the most common candidate for the RSP.
Beginners in RSP should initially choose a 4-5 mm thickness of an even maxillary alveolar ridge and strive to almost double it in width.
A 3-mm alveolar ridge generally consists of 3 thin bone layers (in a horizontal sandwich fashion): 2 cortical plates (about 1 mm each) separated by 1 cancellous layer (about 1 mm). The wider the cancellous bone layer (the layer where the split is done), the easier it will be to accomplish the RSP
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| measurement of alveolar ridge width | Other | Device: measurement of alveolar ridge widththe surgical procedure started with envelop flap reflection. A mucoperiosteal elevator was used to reflect the buccal and palatal flaps that were enough to expose the crestal part of alveolar ridge with clear visibility and accessibility. Measuring the width of the alveolar ridge 1 mm below the crest using bone caliber. Using piezoelectric surgery unit (Piezosurgery Ultrasonic® mectron, Italy), a horizontal crestal cut was produced along the crest of the bone. The cut depth extended into the same depth of the final dental implant to be inserted and then Versah Drills will be used in a successive manner and under copious irrigation with chilled sterile normal saline.We will measure the rate of ridge expansion by bone caliber to determine the efficacy of combining Versah drills with piezo surgery in expanding narrow alveolar bone. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patient's age ≥18 years.
- Absence of any medical disease that compromise wound healing.
- Patient with good oral hygiene.
- Narrow alveolar bone (3-4 mm) with minimum alveolar bone height of (12 mm).
Key exclusion criteria (4 listed)
- Uncontrolled medically compromised patients.
- Heavy smokers (> 10 cigarettes per day).
- Patient with parafunctional habits.
- Local infection at implant site.
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 |
|---|---|---|
| measurement of alveolar ridge widththe surgical procedure started with envelop flap reflection. A mucoperiosteal elevator was used to reflect the buccal and palatal flaps that were enough to expose the crestal part of alveolar ridge with clear visibility and accessibility. Measuring the width of the alveolar ridge 1 mm below the crest using bone caliber. Using piezoelectric surgery unit (Piezosurgery Ultrasonic® mectron, Italy), a horizontal crestal cut was produced along the crest of the bone. The cut depth extended into the same depth of the final dental implant to be inserted and then Versah Drills will be used in a successive manner and under copious irrigation with chilled sterile normal saline.We will measure the rate of ridge expansion by bone caliber to determine the efficacy of combining Versah drills with piezo surgery in expanding narrow alveolar bone. | Device | measurement of alveolar ridge width |
Primary outcome
expansion rate
Time frame: immediately
by digital vernier
expansion rate
Time frame: after 6 months
by digital vernier
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 5 Mar 2024.
- Individual participant dataSharing planned: Yes. It will be mostly available on request.
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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.
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 measurement of alveolar ridge width in people with Dental Implant Failed, run by University of Baghdad at 1 site in Iraq.
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 4 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: finished, as of the sponsor's last update on 5 Mar 2024. 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 Iraq. 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?
expansion rate (time frame: immediately). The study lists 2 primary outcomes in all. 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 5 Mar 2024.