Maxillary Sinus LeftNCT06677125
Magnetic Mallet and Densah Bur for Crestal Sinus Left
A study testing Electrical Mallet and Densah bur in people with Maxillary Sinus Left, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
Background: Implant placement in the posterior maxilla is problematic procedure, not only due to inferior properties of bone but also due to loss of vertical bone height, which happens after extraction of posterior teeth. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Maxillary Sinus Left
- What is being tested?
- Electrical Mallet and Densah bur
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 30 Jan 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient seeking replacement of missing maxillary posterior teeth by dental implant procedure.
- Residual bone height is (5-7) mm measured from crestal bone to sinus floor.
- Both genders.
- Good general health;
- Good oral hygiene.
Who cannot join
- Uncontrolled Diabetes.
- Coagulation disorders.
- Immunological disorders.
- Previous radiation of the head and neck region.
- Presence of chronic systemic diseases;
- Presence of acute or chronic sinus problems;
- Alcohol or drug abuse;
- Heavy smokers.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Alexandria Faculty of Dentistry
Alexandria
Mohamed Abdelbaset, BDS, mohabdelbaset96@gmail.com
mohamed abdelbaset, BDS
About this study
Official title: Magnetic Mallet Versus Densah Bur for Crestal Sinus Left With Implant Placement in Maxilla (Randomized Controlled Clinical Trial)
Background: Implant placement in the posterior maxilla is problematic procedure, not only due to inferior properties of bone but also due to loss of vertical bone height, which happens after extraction of posterior teeth. When the required additional height is few millimeters, indirect transcrestal sinus lifting is recommended. Aim: The aim of this study is to evaluate Densah bur versus Magnetic mallet in transcrestal sinus lifting procedure in edentulous molar and premolar maxillary region.
- Conditions
- Maxillary Sinus Left
- Being tested
- Electrical Mallet, Densah bur
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical MalletProcedure or surgery
The osteotome will be directly attached and pushed by magnetic mallet and a shock wave will be pushed on their tip. The electrical mallet will be imparted to osteotomes a longitudinal movement along a central axis moving up and down toward pilot bone hole providing a driving mechanism of longitudinal movements. Then the sinus lift instruments (Sweden and Martina) will be used to slowly lift the sinus. After that implant will be placed with the help of implant drilling device.
Densah burProcedure or surgery
The implant motor will be adjusted on reverse-densifying mode with 800 to 1200 rpm. According to the desired implant dimension, it will be started with the smallest densah bur. The first densah bur will advanced in densifying mode with bouncing motion in and out movement with copious irrigation until.
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Not described Receives: Procedure: Electrical Mallet |
| Control Group | Active comparator | Not described Receives: Procedure: Densah bur |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain socres
pain will be examined using visual analogue scale (VAS) 0 means no pain 10 means extreme pain
Measured: 3rd day, 1 week and 10 days
change in implant stability
will be measured by the Resonance Frequency Analysis using osstel
Measured: baseline and 4 months
Secondary outcomes (3)
change in implant protrusion length
Immediate post- operative CBCT (T1) will be done to measure the implant protrusion length (IPL) which is the length of the implant extending into the maxillary sinus.
Measured: baseline and 4 months
change in bone density
it will be measured by CBCT
Measured: baseline and 4 months
change in prescence of complications
patients will be followed up to assess the occurence of any clincial complications
Measured: 3rd day, 1 week and 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start1 Jan 2024
- Primary completion30 Jan 2025 (estimated)
- Study completion30 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary Sinus LeftStudies 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
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06677125
- Sponsor's protocol ID
- 814-12
- Status last verified
- Nov 2024
- First submitted
- 5 Nov 2024
- Last updated
- 6 Nov 2024
- 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 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Mallet Versus Densah Bur for Crestal Sinus Left With Implant Placement in Maxilla (Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT06677125
- Acronym / sponsor ID
- 814-12
- Conditions
- Maxillary Sinus Left
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jan 2025 (estimated)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 6 Nov 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.
Background: Implant placement in the posterior maxilla is problematic procedure, not only due to inferior properties of bone but also due to loss of vertical bone height, which happens after extraction of posterior teeth. When the required additional height is few millimeters, indirect transcrestal sinus lifting is recommended. Aim: The aim of this study is to evaluate Densah bur versus Magnetic mallet in transcrestal sinus lifting procedure in edentulous molar and premolar maxillary region.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Procedure: Electrical Mallet |
| Control Group | Active comparator | Procedure: Densah bur |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patient seeking replacement of missing maxillary posterior teeth by dental implant procedure.
- Residual bone height is (5-7) mm measured from crestal bone to sinus floor.
- Both genders.
- Good general health;
- Good oral hygiene.
Key exclusion criteria (8 listed)
- Uncontrolled Diabetes.
- Coagulation disorders.
- Immunological disorders.
- Previous radiation of the head and neck region.
- Presence of chronic systemic diseases;
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 MalletThe osteotome will be directly attached and pushed by magnetic mallet and a shock wave will be pushed on their tip. The electrical mallet will be imparted to osteotomes a longitudinal movement along a central axis moving up and down toward pilot bone hole providing a driving mechanism of longitudinal movements. Then the sinus lift instruments (Sweden and Martina) will be used to slowly lift the sinus. After that implant will be placed with the help of implant drilling device. | Procedure or surgery | Test Group |
| Densah burThe implant motor will be adjusted on reverse-densifying mode with 800 to 1200 rpm. According to the desired implant dimension, it will be started with the smallest densah bur. The first densah bur will advanced in densifying mode with bouncing motion in and out movement with copious irrigation until. | Procedure or surgery | Control Group |
Primary outcome
Change in pain socres
Time frame: 3rd day, 1 week and 10 days
pain will be examined using visual analogue scale (VAS) 0 means no pain 10 means extreme pain
change in implant stability
Time frame: baseline and 4 months
will be measured by the Resonance Frequency Analysis using osstel
3 secondary outcomes
change in implant protrusion length
Time frame: baseline and 4 months
change in bone density
Time frame: baseline and 4 months
change in prescence of complications
Time frame: 3rd day, 1 week and 10 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical Mallet and Densah bur in people with Maxillary Sinus Left, run by Hams Hamed Abdelrahman 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 5 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: looking for participants now, as of the sponsor's last update on 6 Nov 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Abdelbaset, BDS (01017900706, mohabdelbaset96@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain socres (time frame: 3rd day, 1 week and 10 days). 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 6 Nov 2024.