Implant Tissue FailureNCT03732885
Maxillary Sinus Floor Elevation Using DENSAH Burs Versus Summers Osteotomes
A study testing densah burs osseo densification drills and Summer's Osteotomes in people with Implant Tissue Failure, run by Cairo University at 1 site in Egypt.
Trial summary
To investigate the efficacy of osseodensification drills (Densah bure) as a new closed sinus lift tool and to compare the effect of it in bone gaine versus traditional osteotomes. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Implant Tissue Failure
- What is being tested?
- densah burs osseo densification drills and Summer's Osteotomes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2018to 15 Jul 2019
- 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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with partially edentulous in the posterior area of the maxilla, with a residual ridge that allowed insertion of ≤8 mm length implants.
- both sexes.
- No intraoral soft and hard tissue pathology
- No systemic condition that contraindicate implant placement.
Who cannot join
- Sinus pathology.
- Heavy smokers more than 20 cigarettes per day.
- Patients with systemic disease that may affect normal healing.
- Psychiatric problems.
- Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Crestal Maxillary Sinus Floor Elevation Using Osseodensification Drills (Densah Burs) Versus Summers Osteotomes
To investigate the efficacy of osseodensification drills (Densah bure) as a new closed sinus lift tool and to compare the effect of it in bone gaine versus traditional osteotomes.
- Conditions
- Implant Tissue Failure
- Being tested
- densah burs osseo densification drills, Summer's Osteotomes
- Keywords
- Sinus, Stability, Bone gain, Osseodensification
- Medical subject headings
- Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
densah burs osseo densification drillsDevice
maxillary sinus floor elevation during implant placement using Densah burs
Summer's OsteotomesDevice
maxillary sinus floor elevation during implant placement using Summer's Osteotomes
| Study group | Role | What they receive |
|---|---|---|
| densah burs drilling group | Experimental | maxillary sinus floor elevation during implant placement using Densah burs Receives: Device: densah burs osseo densification drills |
| Summers osteotomes | Experimental | maxillary sinus floor elevation during implant placement using Summer's Osteotomes Receives: Device: Summer's Osteotomes |
What is being measured
The primary outcome is the main question the study is designed to answer.
implant stability
measurement of implant stability using the Ostell
Measured: 6 months after surgery
Secondary outcomes (1)
bone gain
measurement of bone gain around implant using cone-beam computed tomography CBCT
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start1 Nov 2018 (estimated)
- Primary completion15 Apr 2019 (estimated)
- Study completion15 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant Tissue FailureStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sohaib Mohamed Alzamzamy Mohamed Elsheikh, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03732885
- Sponsor's protocol ID
- NCT035
- Status last verified
- Nov 2018
- First submitted
- 30 Oct 2018
- Last updated
- 7 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Crestal Maxillary Sinus Floor Elevation Using Osseodensification Drills (Densah Burs) Versus Summers Osteotomes
- ClinicalTrials.gov ID
- NCT03732885
- Acronym / sponsor ID
- NCT035
- Conditions
- Implant Tissue Failure
- Keywords
- Sinus, Stability, Bone gain, Osseodensification
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (estimated)
- Primary completion
- 15 Apr 2019 (estimated)
- Study completion
- 15 Jul 2019 (estimated)
- First posted
- 7 Nov 2018 (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.
To investigate the efficacy of osseodensification drills (Densah bure) as a new closed sinus lift tool and to compare the effect of it in bone gaine versus traditional osteotomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| densah burs drilling group | Experimental | Device: densah burs osseo densification drillsmaxillary sinus floor elevation during implant placement using Densah burs |
| Summers osteotomes | Experimental | Device: Summer's Osteotomesmaxillary sinus floor elevation during implant placement using Summer's Osteotomes |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with partially edentulous in the posterior area of the maxilla, with a residual ridge that allowed insertion of ≤8 mm length implants.
- both sexes.
- No intraoral soft and hard tissue pathology
- No systemic condition that contraindicate implant placement.
Key exclusion criteria (5 listed)
- Sinus pathology.
- Heavy smokers more than 20 cigarettes per day.
- Patients with systemic disease that may affect normal healing.
- Psychiatric problems.
- Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to 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 |
|---|---|---|
| densah burs osseo densification drillsmaxillary sinus floor elevation during implant placement using Densah burs | Device | densah burs drilling group |
| Summer's Osteotomesmaxillary sinus floor elevation during implant placement using Summer's Osteotomes | Device | Summers osteotomes |
Primary outcome
implant stability
Time frame: 6 months after surgery
measurement of implant stability using the Ostell
1 secondary outcome
bone gain
Time frame: 6 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing densah burs osseo densification drills and Summer's Osteotomes in people with Implant Tissue Failure, run by Cairo University 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 4 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 7 Nov 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sohaib M Elsheikh, masters (00201222500517 ext. 0, alzamzamy44@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
implant stability (time frame: 6 months after surgery). 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 7 Nov 2018.