Primary Stability of ImplantsNCT03661957
Non Grafted Maxillary Sinus Floor Elevation With Implant Placement Versus the Use of Short Endosseous Implants
A study testing Non grafted maxillary sinus floor elevation with simultaneous implant placement and using short dental implants for posterior atrophic maxilla in people with Primary Stability of Implants and Marginal Bone Loss, run by Cairo University at 1 site in Egypt.
Trial summary
Assessment the need for sinus floor elevation when restoring atrophic posterior maxilla or it will be enough to use of short implant Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Stability of Implants, Marginal Bone Loss
- What is being tested?
- Non grafted maxillary sinus floor elevation with simultaneous implant placement and using short dental implants for posterior atrophic maxilla
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2018to Apr 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 60 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
- Immunodeficiency pathology, bruxism, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ahmed Maher Mansour
Cairo
ahmed maher mansour, BDS, 00201092955447, a7mad.maher10@gmail.com
About this study
Official title: Non Grafted Maxillary Sinus Floor Elevation With Simultaneous Implant Placement Versus the Use of Short Endosseous Implants
Assessment the need for sinus floor elevation when restoring atrophic posterior maxilla or it will be enough to use of short implant
- Conditions
- Primary Stability of Implants, Marginal Bone Loss
- Being tested
- Non grafted maxillary sinus floor elevation with simultaneous implant placement, using short dental implants for posterior atrophic maxilla
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non grafted maxillary sinus floor elevation with simultaneous implant placementProcedure or surgery
lateral window for sinus elevation ,membrane elevation ,implant placement , membrane for window closure
using short dental implants for posterior atrophic maxillaProcedure or surgery
placement of short dental implant with bone height below 8mm
| Study group | Role | What they receive |
|---|---|---|
| Non grafted maxillary sinus floor elevation with implant pacem | Active comparator | Not described Receives: Procedure: Non grafted maxillary sinus floor elevation with simultaneous implant placement |
| using short dental implants for posterior atrophic maxilla | Experimental | Not described Receives: Procedure: using short dental implants for posterior atrophic maxilla |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary stability
measuring primary stability using osstel
Measured: 6 months
Secondary outcomes (1)
marginal bone loss
measuring marginal bone loss using cone beam ct
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 posted7 Sep 2018
- Study startSep 2018 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Stability of ImplantsStudies 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Maher Mansour, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03661957
- Sponsor's protocol ID
- cairo university 99
- Status last verified
- Sep 2018
- First submitted
- 2 Sep 2018
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Grafted Maxillary Sinus Floor Elevation With Simultaneous Implant Placement Versus the Use of Short Endosseous Implants
- ClinicalTrials.gov ID
- NCT03661957
- Acronym / sponsor ID
- cairo university 99
- Conditions
- Primary Stability of Implants, Marginal Bone Loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2018 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 7 Sep 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.
Assessment the need for sinus floor elevation when restoring atrophic posterior maxilla or it will be enough to use of short implant
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 |
|---|---|---|
| Non grafted maxillary sinus floor elevation with implant pacem | Active comparator | Procedure: Non grafted maxillary sinus floor elevation with simultaneous implant placement |
| using short dental implants for posterior atrophic maxilla | Experimental | Procedure: using short dental implants for posterior atrophic maxilla |
Who may qualify
- Ages
- 25 to 60 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 (6 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 |
|---|---|---|
| Non grafted maxillary sinus floor elevation with simultaneous implant placementlateral window for sinus elevation ,membrane elevation ,implant placement , membrane for window closure | Procedure or surgery | Non grafted maxillary sinus floor elevation with implant pacem |
| using short dental implants for posterior atrophic maxillaplacement of short dental implant with bone height below 8mm | Procedure or surgery | using short dental implants for posterior atrophic maxilla |
Primary outcome
primary stability
Time frame: 6 months
measuring primary stability using osstel
1 secondary outcome
marginal bone loss
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 7 Sep 2018.
- Individual participant dataSharing planned: Yes
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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 Non grafted maxillary sinus floor elevation with simultaneous implant placement and using short dental implants for posterior atrophic maxilla in people with Primary Stability of Implants and Marginal Bone Loss, 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 6 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 Sep 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?
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?
primary stability (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 7 Sep 2018.