Compromised Vertical Bone Height in the Maxillary Posterior RegionNCT02926781
A Comparative Study to Evaluate Bone Height Gain Following Transcrestal Sinus Floor Elevation Using Specially Designed Drills Versus the Conventional Osteotome Technique.
A study testing Dask Advanced Sinus kit in people with Compromised Vertical Bone Height in the Maxillary Posterior Region, run by Cairo University.
Trial summary
Radiographic evaluation of the amount of bone height gain and clinical evaluation of the possibility of developing complications after transcrestal sinus floor elevation using drills and the conventional osteotome technique. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Compromised Vertical Bone Height in the Maxillary Posterior Region
- What is being tested?
- Dask Advanced Sinus kit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Aug 2017
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients having at least one missing upper posterior tooth.
- Residual bone height beneath maxillary sinus from 5-8 mm .
- A minimum of 6 mm residual bone width.
- The recipient site of the implant should be free from any pathological condition.
- No diagnosed bone disease or medication known to affect bone metabolism.
- Patients who are cooperative, motivated and hygiene conscious.
- Patients having proper inter-occlusal space.
Who cannot join
- Systemic conditions/disease that contraindicated 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
No sites are listed yet.
About this study
Official title: A Comparative Study to Evaluate Bone Height Gain Following Transcrestal Sinus Floor Elevation Using Specially Designed Drills Versus the Conventional Osteotome Technique: a Randomized Controlled Clinical Trial.
Radiographic evaluation of the amount of bone height gain and clinical evaluation of the possibility of developing complications after transcrestal sinus floor elevation using drills and the conventional osteotome technique.
Read the detailed description
Short implants (< 10 mm) are one of the options used to overcome low vertical bone height in the maxilla. However, short implants have faced many challenges as smaller implant surface; therefore less bone-to-implant contact after osseointegration with force distribution on a reduced surface after loading. This leads to more crestal bone resorption with more threads exposure decreasing the long term implant success Another treatment option is placing implants in specific anatomical areas, such as the pterygoid region or the zygoma .Many complications are reported as postoperative sinusitis, temporary paresthesia, epistaxis, facial, periorbital hematoma, orbital penetration and prosthetic difficulties due to the implants palatal emergence.
Vertical augmentation with bone grafts is another treatment option. However, it has many drawbacks as the unpredictable graft resorption, low bone to implant contact, higher possibility of wound dehiscence, as well as compromised implant position leading to undesirable prosthetic restorations.
To overcome the problems of the previously mentioned procedures, elevation of the sinus membrane techniques were proposed, it can be performed either through a lateral window , or via a crestal access depending on the remaining bone height (RBH). If the RBH is around 6-9 mm, the crestal approach is indicated. If the RBH is less than 5 mm, a lateral approach should be performed.
For the crestal approach, it could be performed by the conventional osteotome technique. However, it is a visually restrictive technique which may lead to sinus perforation as well as it can cause some complications as headache and paroxysmal positional vertigo (Saker e Ogle, 2005; Peñarrocha-Diago et al., 2008).
To overcome the disadvantages of the conventional osteotome technique, various kits have been developed for transcrestal sinus floor elevations using specially designed drills.
- Being tested
- Dask Advanced Sinus kit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dask Advanced Sinus kitDevice
a kit of specially designed drills for closed sinus lift
| Study group | Role | What they receive |
|---|---|---|
| osteotome technique | Experimental | transcrestal sinus floor elevation using osteotomes Receives: Device: Dask Advanced Sinus kit |
| drills | Active comparator | transcrestal sinus floor elevation using drills Receives: Device: Dask Advanced Sinus kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone height gain
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 posted6 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionJan 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Compromised Vertical Bone Height in the Maxillary Posterior RegionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Ashour, Cairo University
- Investigators
- Omar A Ashour, Bachelor, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02926781
- Sponsor's protocol ID
- Omar Ashour
- Status last verified
- Oct 2016
- First submitted
- 3 Oct 2016
- Last updated
- 6 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study to Evaluate Bone Height Gain Following Transcrestal Sinus Floor Elevation Using Specially Designed Drills Versus the Conventional Osteotome Technique: a Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT02926781
- Acronym / sponsor ID
- Omar Ashour
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 6 Oct 2016 (estimated)
- 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.
Radiographic evaluation of the amount of bone height gain and clinical evaluation of the possibility of developing complications after transcrestal sinus floor elevation using drills and the conventional osteotome technique.
Detailed description
Short implants (< 10 mm) are one of the options used to overcome low vertical bone height in the maxilla. However, short implants have faced many challenges as smaller implant surface; therefore less bone-to-implant contact after osseointegration with force distribution on a reduced surface after loading. This leads to more crestal bone resorption with more threads exposure decreasing the long term implant success Another treatment option is placing implants in specific anatomical areas, such as the pterygoid region or the zygoma .Many complications are reported as postoperative sinusitis, temporary paresthesia, epistaxis, facial, periorbital hematoma, orbital penetration and prosthetic difficulties due to the implants palatal emergence.
Vertical augmentation with bone grafts is another treatment option. However, it has many drawbacks as the unpredictable graft resorption, low bone to implant contact, higher possibility of wound dehiscence, as well as compromised implant position leading to undesirable prosthetic restorations.
To overcome the problems of the previously mentioned procedures, elevation of the sinus membrane techniques were proposed, it can be performed either through a lateral window , or via a crestal access depending on the remaining bone height (RBH). If the RBH is around 6-9 mm, the crestal approach is indicated. If the RBH is less than 5 mm, a lateral approach should be performed.
For the crestal approach, it could be performed by the conventional osteotome technique. However, it is a visually restrictive technique which may lead to sinus perforation as well as it can cause some complications as headache and paroxysmal positional vertigo (Saker e Ogle, 2005; Peñarrocha-Diago et al., 2008).
To overcome the disadvantages of the conventional osteotome technique, various kits have been developed for transcrestal sinus floor elevations using specially designed drills.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| osteotome technique | Experimental | Device: Dask Advanced Sinus kittranscrestal sinus floor elevation using osteotomes |
| drills | Active comparator | Device: Dask Advanced Sinus kittranscrestal sinus floor elevation using drills |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients having at least one missing upper posterior tooth.
- Residual bone height beneath maxillary sinus from 5-8 mm .
- A minimum of 6 mm residual bone width.
- The recipient site of the implant should be free from any pathological condition.
- No diagnosed bone disease or medication known to affect bone metabolism.
Key exclusion criteria (5 listed)
- Systemic conditions/disease that contraindicated 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.
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 |
|---|---|---|
| Dask Advanced Sinus kita kit of specially designed drills for closed sinus lift | Device | drills, osteotome technique |
Primary outcome
bone height gain
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2016.
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.
Omar A Ashour, Bachelor principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Dask Advanced Sinus kit in people with Compromised Vertical Bone Height in the Maxillary Posterior Region, run by Cairo 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 7 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 6 Oct 2016. 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 Omar A Ashour, Bachelor (01115537575, o.ashour@live.com), 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). 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 Oct 2016.