Maxillary Sinus DiseaseNCT05411510
Evaluation of Bone Height Gain Following Trans-crestal Sinus Floor Elevation
A study testing Densah bur in people with Maxillary Sinus Disease, run by Ahmed Mohamed Said Rozeik at 2 sites in Egypt.
Trial summary
Missing teeth usually result in functional and cosmetic deficits. Traditionally, they have been restored with dentures or fixed bridges. However, dental implants represent an excellent alternative which rely on the maintenance of a direct structural and functional connection between living bone and implant surface… Read more about this study
- Who is it for?
- Ages 23 to 60 years
- Conditions the study is for
- Maxillary Sinus Disease
- What is being tested?
- Densah bur
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesEgypt
- Study dates
- 20 Aug 2022to 20 Dec 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 23 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ● Patients having one missing upper posterior tooth with residual bone height beneath maxillary sinus from 5-8 mm.
- A minimum of 6 mm residual bone width at site of implant placement.
- The recipient site of the implant should be free from any pathological conditions.
- No diagnosed bone disease or medication known to affect bone metabolism.
- Patients who are cooperative, motivated and hygiene conscious.
- Patients having adequate inter-occlusal space of 8-10 mm
Who cannot join
- ● Systemic conditions/diseases that contraindicate surgery.
- Radiation therapy in the head and neck region or chemotherapy during the 12 months prior to surgery.
- Patients who have any habits that might jeopardize the osseointegration process, such as current smokers.
- Patients with parafunctional habits that produce overload on implant, such as bruxism and clenching.
- Patients that have any pathology in the maxillary sinuses.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Cairo University
Cairo, 002
Ahmed Rozeik, Master
Faculty of Dentistry
Cairo, 002
Omar Ashour, PhD, 01115537575, a.saeed8979@gmail.com
Ahmed Rozeik, Master
About this study
Official title: Evaluation of Bone Height Gain Following Trans-crestal Sinus Floor Elevation Using the Densifying Bur in Comparison to The Conventional Osteotome In Patients With Atrophic Posterior Maxillae: A Randomized Controlled Clinical Trial
Missing teeth usually result in functional and cosmetic deficits. Traditionally, they have been restored with dentures or fixed bridges. However, dental implants represent an excellent alternative which rely on the maintenance of a direct structural and functional connection between living bone and implant surface, which is termed osseointergration . When sufficient bone is available in maxilla, implant rehabilitation has shown high success rates of 84-92 %. Atrophy of the alveolar crest and pneumatization of the maxillary sinus limits the quality and quantity of residual bone, therefore complicating the placement of implants in the posterior maxillary area.
Read the detailed description
Among the techniques used to overcome low vertical bone height in the maxilla is maxillary sinus floor augmentation. It can be performed either through a lateral window, or via a crestal access. Many long term studies and systematic reviews have showed that osteotome mediated sinus floor elevation (OSFE) technique is a highly predictable method for rehabilitation of patients with atrophied posterior maxilla with survival rates ranging from 92 % to 100 %. However, endoscopic studies have demonstrated the risk of membrane perforation while performing transalveolar sinus floor elevation. Moreover, the Summers technique can cause some complications as headache and paroxysmal positional vertigo. Additionally, the activity of osteotomes during the application of malleting pressure is difficult to control, resulting in unwanted instrument and/or graft penetration into the sinus cavity, potentially causing membrane penetration.
However, Huwais invented a new technology termed osseodensification for enhancing implant primary stability in 2015. This technology is performed with the use of specially developed drill bits (Densah burs) that combine the benefits of osteotomes with tactile control during the expansion. They have four or more lands with a negative rake angle, which prevents the bur's edges from cutting the bone and so compacts it smoothly. These drills have a tapered shank and a cutting chisel edge. They can thus go deeper into the osteotomy site, while the drill's gradually increasing diameter aids in the site's gradual enlargement. Drills are utilized to enter into the bone in a clockwise rotation (Cutting mode) until the appropriate depth of the osteotomy is reached. Afterwards, counterclockwise rotations (Densifying mode) generate a robust and dense layer of bone tissue along the osteotomy's walls and base. Through controlled deformation, this procedure burnishes bone along the inner layer of the osteotomy site. The goal is to construct a condensed layer of autografted bone along the implant's periphery and apex. This would improve the bone-implant contact, hence increasing insertion torque values and, as a result, implant primary stability.
- Conditions
- Maxillary Sinus Disease
- Being tested
- Densah bur
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Densah burProcedure or surgery
Also called Densifying bur
Surgical treatment
| Study group | Role | What they receive |
|---|---|---|
| Densah bur | Experimental | According to the protocol for densah burs. The direction was reversed and the cutting speed was raised to 1200 rpm after the initial perforation close to the sinus floor. After that, two densifying burs were used in succession to elevate the sinus membrane by 2 mm and prepare the implant hole to the desired implant size. Receives: Procedure: Densah bur |
| Ostetome | Active comparator | Flat end osteotome of appropriate size will be introduced through the osteotomy to infracture the floor of the sinus by light malleting. Receives: Procedure: Densah bur |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone gain height
It will be measured using Cone beam computed tomography (CBCT) in mm
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start20 Aug 2022 (estimated)
- Primary completion20 Feb 2023 (estimated)
- Study completion20 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary Sinus DiseaseStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahmed Mohamed Said Rozeik
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Mohamed Said Rozeik, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05411510
- Sponsor's protocol ID
- 2022
- Status last verified
- Jun 2022
- First submitted
- 20 May 2022
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Bone Height Gain Following Trans-crestal Sinus Floor Elevation Using the Densifying Bur in Comparison to The Conventional Osteotome In Patients With Atrophic Posterior Maxillae: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05411510
- Acronym / sponsor ID
- 2022
- Conditions
- Maxillary Sinus Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ahmed Mohamed Said RozeikUniversity, hospital or other
- Study start
- 20 Aug 2022 (estimated)
- Primary completion
- 20 Feb 2023 (estimated)
- Study completion
- 20 Dec 2023 (estimated)
- First posted
- 9 Jun 2022 (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.
Missing teeth usually result in functional and cosmetic deficits. Traditionally, they have been restored with dentures or fixed bridges. However, dental implants represent an excellent alternative which rely on the maintenance of a direct structural and functional connection between living bone and implant surface, which is termed osseointergration . When sufficient bone is available in maxilla, implant rehabilitation has shown high success rates of 84-92 %. Atrophy of the alveolar crest and pneumatization of the maxillary sinus limits the quality and quantity of residual bone, therefore complicating the placement of implants in the posterior maxillary area.
Detailed description
Among the techniques used to overcome low vertical bone height in the maxilla is maxillary sinus floor augmentation. It can be performed either through a lateral window, or via a crestal access. Many long term studies and systematic reviews have showed that osteotome mediated sinus floor elevation (OSFE) technique is a highly predictable method for rehabilitation of patients with atrophied posterior maxilla with survival rates ranging from 92 % to 100 %. However, endoscopic studies have demonstrated the risk of membrane perforation while performing transalveolar sinus floor elevation. Moreover, the Summers technique can cause some complications as headache and paroxysmal positional vertigo. Additionally, the activity of osteotomes during the application of malleting pressure is difficult to control, resulting in unwanted instrument and/or graft penetration into the sinus cavity, potentially causing membrane penetration.
However, Huwais invented a new technology termed osseodensification for enhancing implant primary stability in 2015. This technology is performed with the use of specially developed drill bits (Densah burs) that combine the benefits of osteotomes with tactile control during the expansion. They have four or more lands with a negative rake angle, which prevents the bur's edges from cutting the bone and so compacts it smoothly. These drills have a tapered shank and a cutting chisel edge. They can thus go deeper into the osteotomy site, while the drill's gradually increasing diameter aids in the site's gradual enlargement. Drills are utilized to enter into the bone in a clockwise rotation (Cutting mode) until the appropriate depth of the osteotomy is reached. Afterwards, counterclockwise rotations (Densifying mode) generate a robust and dense layer of bone tissue along the osteotomy's walls and base. Through controlled deformation, this procedure burnishes bone along the inner layer of the osteotomy site. The goal is to construct a condensed layer of autografted bone along the implant's periphery and apex. This would improve the bone-implant contact, hence increasing insertion torque values and, as a result, implant primary stability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Densah bur | Experimental | Procedure: Densah burAccording to the protocol for densah burs. The direction was reversed and the cutting speed was raised to 1200 rpm after the initial perforation close to the sinus floor. After that, two densifying burs were used in succession to elevate the sinus membrane by 2 mm and prepare the implant hole to the desired implant size. |
| Ostetome | Active comparator | Procedure: Densah burFlat end osteotome of appropriate size will be introduced through the osteotomy to infracture the floor of the sinus by light malleting. |
Who may qualify
- Ages
- 23 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- ● Patients having one missing upper posterior tooth with residual bone height beneath maxillary sinus from 5-8 mm.
Key exclusion criteria (5 listed)
- ● Systemic conditions/diseases that contraindicate surgery.
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 |
|---|---|---|
| Densah burAlso: Densifying burSurgical treatment | Procedure or surgery | Densah bur, Ostetome |
Primary outcome
Bone gain height
Time frame: 6 months
It will be measured using Cone beam computed tomography (CBCT) in mm
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Maxillary Sinus Disease
Not yet recruiting
Efficacy of Bioactive Glass vs. Xenograft in Maxillary Sinus Augmentation
Alveolar Bone Loss, Maxillary Sinus Disease
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Densah bur in people with Maxillary Sinus Disease, run by Ahmed Mohamed Said Rozeik at 2 sites 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 6 inclusion and 5 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 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 gain height (time frame: 6 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 9 Jun 2022; AzTrials last refreshed its copy on 7 Nov 2026.