Alveolar Bone LossNCT06180187
Densah Burs vs. Electrical Mallet in Closed Sinus Lifting.
A study testing Electrical mallet and Osseo-densification burs in people with Alveolar Bone Loss, run by Fayoum University.
Trial summary
The aim of the comparative study is to evaluate the density and amount of new bone formed (bone height gain)around dental implant placed simultaneously in posterior maxilla after closed sinus floor elevation using Osseodensification burs versus electrical mallet. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alveolar Bone Loss
- What is being tested?
- Electrical mallet and Osseo-densification burs
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with partially edentulous posterior maxilla
- Residual bone height ≥ 5mm
- Oral hygiene : fair oral hygiene
Who cannot join
- Smoking
- Systematic disease that affects bone remodeling (e.g. uncontrolled Diabetes mellitus or osteoporosis)
- Radiotherapy to head and neck or chemotherapy
- Chronic disease of maxillary sinus
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Radiographic and Clinical Comparative Study Between Osseodensification Burs and Electrical Mallet in Closed Sinus Floor Elevation and Simultaneous Implant Placement. Prospective Clinical Trial.
The aim of the comparative study is to evaluate the density and amount of new bone formed (bone height gain)around dental implant placed simultaneously in posterior maxilla after closed sinus floor elevation using Osseodensification burs versus electrical mallet.
Read the detailed description
Extraction of posterior teeth in the maxilla for long time without rehabilitation of the area increases the incidence of maxillary sinus pneumatization that makes maxillary sinus enlarges in volume over the residual bone of alveolar ridge.
Decreasing the height of sub_ antral bone affects adversely on the bone density which is crucial for implant primary stability causing placement of dental implant quite challenging requiring sinus lifting procedure and bone condensation of residual ridge in addition to bone grafting
Summers technique considered the gold standard for closed sinus floor elevation using osteotome and a hand mallet to condense alveolar bone and elevate schneiderian membrane. One of drawbacks of this technique is benign paroxysmal positional vertigo due to force applied by hand mallet is not controlled.
Electrical mallet was introduced to overcome (BPPV) as it applies controlled force (daN) in short fraction of seconds(µs) with hand piece secured totally by the surgeon and have a wide variety of instruments placed on the hand piece e.g. osteotomes used in sinus floor elevation .
Controlled force of magnetic mallet decrees the risk of schneiderian membrane perforation
Osseodensification burs now show great outcomes in closed sinus lifting procedure.
Densah burs increase the density of alveolar bone which increase the primary stability of dental implants .
Aim of this study is to compare Electrical mallet with Osseodensification burs in closed sinus lifting.
- Conditions
- Alveolar Bone Loss
- Being tested
- Electrical mallet, Osseo-densification burs
- Keywords
- sinus lift, electrical mallet, osseodensification, bone density
- 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.
Electrical malletDevice
elevation of the Schneiderian membrane of maxillary sinus using electrical mallet and place bone graft material to augment the residual alveolar ridge and then place dental implant .
Osseo-densification bursDevice
elevation of the Schneiderian membrane of maxillary sinus using osseodensification burs and place bone graft material to augment the residual alveolar ridge and then place dental implant .
| Study group | Role | What they receive |
|---|---|---|
| Osseo-densification group | Active comparator | Not described Receives: Device: Osseo-densification burs |
| Electrical mallet group | Active comparator | Not described Receives: Device: Electrical mallet |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone height gain
Evaluate the change in bone height radiographically after closed sinus floor elevation and simultaneous implant placement .using cone beam computed tomography immediate after surgery and 6 months post operative .
Measured: 6 months follow up
change in bone density
Evaluate the amount of change in bone density around dental implant immediately post operative and after 6 months.
Measured: 6 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2023
- Study startDec 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone LossStudies 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
- group I (Osseo Densification group) Patients in this group will have sinus floor elevation using osseodensification burs then application of PRF membrane through the socket to protect schneiderian membrane and application of sticky bone (xeno graft and i-PRF) to augment alveolar ridge to receive dental implant group II (electrical mallet group) Patients in this group will have sinus floor elevation using electrical mallet then application of PRF membrane through the socket to protect schneiderian membrane and application of sticky bone (xeno graft and i-PRF) to augment alveolar ridge to receive dental implant
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman sayed mostafa elsayed, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06180187
- Sponsor's protocol ID
- 1222023
- Status last verified
- Dec 2023
- First submitted
- 4 Dec 2023
- Last updated
- 22 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiographic and Clinical Comparative Study Between Osseodensification Burs and Electrical Mallet in Closed Sinus Floor Elevation and Simultaneous Implant Placement. Prospective Clinical Trial.
- ClinicalTrials.gov ID
- NCT06180187
- Acronym / sponsor ID
- 1222023
- Conditions
- Alveolar Bone Loss
- Keywords
- sinus lift, electrical mallet, osseodensification, bone density
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 22 Dec 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.
The aim of the comparative study is to evaluate the density and amount of new bone formed (bone height gain)around dental implant placed simultaneously in posterior maxilla after closed sinus floor elevation using Osseodensification burs versus electrical mallet.
Detailed description
Extraction of posterior teeth in the maxilla for long time without rehabilitation of the area increases the incidence of maxillary sinus pneumatization that makes maxillary sinus enlarges in volume over the residual bone of alveolar ridge.
Decreasing the height of sub_ antral bone affects adversely on the bone density which is crucial for implant primary stability causing placement of dental implant quite challenging requiring sinus lifting procedure and bone condensation of residual ridge in addition to bone grafting
Summers technique considered the gold standard for closed sinus floor elevation using osteotome and a hand mallet to condense alveolar bone and elevate schneiderian membrane. One of drawbacks of this technique is benign paroxysmal positional vertigo due to force applied by hand mallet is not controlled.
Electrical mallet was introduced to overcome (BPPV) as it applies controlled force (daN) in short fraction of seconds(µs) with hand piece secured totally by the surgeon and have a wide variety of instruments placed on the hand piece e.g. osteotomes used in sinus floor elevation .
Controlled force of magnetic mallet decrees the risk of schneiderian membrane perforation
Osseodensification burs now show great outcomes in closed sinus lifting procedure.
Densah burs increase the density of alveolar bone which increase the primary stability of dental implants .
Aim of this study is to compare Electrical mallet with Osseodensification burs in closed sinus lifting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- group I (Osseo Densification group) Patients in this group will have sinus floor elevation using osseodensification burs then application of PRF membrane through the socket to protect schneiderian membrane and application of sticky bone (xeno graft and i-PRF) to augment alveolar ridge to receive dental implant group II (electrical mallet group) Patients in this group will have sinus floor elevation using electrical mallet then application of PRF membrane through the socket to protect schneiderian membrane and application of sticky bone (xeno graft and i-PRF) to augment alveolar ridge to receive dental implant
| Arm | Type | Receives |
|---|---|---|
| Osseo-densification group | Active comparator | Device: Osseo-densification burs |
| Electrical mallet group | Active comparator | Device: Electrical mallet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with partially edentulous posterior maxilla
- Residual bone height ≥ 5mm
- Oral hygiene : fair oral hygiene
Key exclusion criteria (4 listed)
- Smoking
- Systematic disease that affects bone remodeling (e.g. uncontrolled Diabetes mellitus or osteoporosis)
- Radiotherapy to head and neck or chemotherapy
- Chronic disease of maxillary sinus
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 |
|---|---|---|
| Electrical malletelevation of the Schneiderian membrane of maxillary sinus using electrical mallet and place bone graft material to augment the residual alveolar ridge and then place dental implant . | Device | Electrical mallet group |
| Osseo-densification burselevation of the Schneiderian membrane of maxillary sinus using osseodensification burs and place bone graft material to augment the residual alveolar ridge and then place dental implant . | Device | Osseo-densification group |
Primary outcome
bone height gain
Time frame: 6 months follow up
Evaluate the change in bone height radiographically after closed sinus floor elevation and simultaneous implant placement .using cone beam computed tomography immediate after surgery and 6 months post operative .
change in bone density
Time frame: 6 months follow up
Evaluate the amount of change in bone density around dental implant immediately post operative and after 6 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical mallet and Osseo-densification burs in people with Alveolar Bone Loss, 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 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 22 Dec 2023. 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 abdelrahman S mostafa (1060641063 ext. +20, as3059@fayoum.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bone height gain (time frame: 6 months follow up). 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 22 Dec 2023.