Sinus LiftNCT05044260
Sinus Lift Using PTFE Titanium Reinforced Membrane
A study testing Direct sinus lift with titanium reinforced PTFE membrane in people with Sinus Lift, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
Various attempts have been implemented using different materials and techniques to augment the maxillary sinus floor enhancing autogenous bone formation to allow proper dental implant positioning. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Sinus Lift
- What is being tested?
- Direct sinus lift with titanium reinforced PTFE membrane
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2020to 20 Oct 2021
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients of both genders requiring implant placement in posterior maxilla
- Age range: 40-60 years.
- Good oral hygiene
- Healthy maxillary sinus free from pathology
- The minimum crestal bone height is (4-6) mm
- Patients who are willing and fully capable to comply with the study protocol.
Who cannot join
- Sinus infection
- Tumors or pathologic lesions in sinus
- Severe allergic rhinitis.
- Chronic topical steroid use.
- Radiation therapy.
- Psychologic / mental impairment
Show all 12Show fewer
- Acute infection (periodontitis or mucosal infection
- Patients on radiotherapy or chemotherapy.
- Alcohol or drug abuse.
- Patient with systemic disorder (uncontrolled Diabetes mellitus, autoimmune diseases, bone diseases, etc.)
- Smokers
- Parafuctional habits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Direct Sinus Lift Using Ptfe Titanium Reinfored Membrane Assosiated With Immediate Implant Placement (Clinical Trial)
Various attempts have been implemented using different materials and techniques to augment the maxillary sinus floor enhancing autogenous bone formation to allow proper dental implant positioning. The aim of this study is to evaluate the sinus lift procedure using polytetrafluoroethylene (PTFE) titanium-reinforced membrane to maintain the space formed after Schneiderian membrane elevation followed by immediate implant placement.
- Conditions
- Sinus Lift
- Being tested
- Direct sinus lift with titanium reinforced PTFE membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct sinus lift with titanium reinforced PTFE membraneProcedure or surgery
Implants will be placed immediately after sinus lifting procedure and maintaining the sinus membrane in position using PTFE titanium reinforced membrane.
| Study group | Role | What they receive |
|---|---|---|
| Direct Sinus elevation using SLA Kit | Experimental | Not described Receives: Procedure: Direct sinus lift with titanium reinforced PTFE membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in implant stability
It will be measured using Osstell
Measured: at baseline and 6 months
Change in bone formation
It will be measured uisng CBCT on Demand 3d software
Measured: at baseline and 6 months
Change in bone height
It will be measured uisng CBCT on Demand 3d software
Measured: at baseline and 6 months
Change in bone density
It will be measured uisng CBCT on Demand 3d software
Measured: at baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start1 Sep 2020
- Primary completion20 Oct 2021 (estimated)
- Study completion20 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sinus LiftStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 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
- NCT05044260
- Sponsor's protocol ID
- sinus_lift2020
- Status last verified
- Sep 2021
- First submitted
- 6 Sep 2021
- Last updated
- 14 Sep 2021
- 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 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Direct Sinus Lift Using Ptfe Titanium Reinfored Membrane Assosiated With Immediate Implant Placement (Clinical Trial)
- ClinicalTrials.gov ID
- NCT05044260
- Acronym / sponsor ID
- sinus_lift2020
- Conditions
- Sinus Lift
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 20 Oct 2021 (estimated)
- Study completion
- 20 Oct 2021 (estimated)
- First posted
- 14 Sep 2021 (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.
Various attempts have been implemented using different materials and techniques to augment the maxillary sinus floor enhancing autogenous bone formation to allow proper dental implant positioning. The aim of this study is to evaluate the sinus lift procedure using polytetrafluoroethylene (PTFE) titanium-reinforced membrane to maintain the space formed after Schneiderian membrane elevation followed by immediate implant placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Direct Sinus elevation using SLA Kit | Experimental | Procedure: Direct sinus lift with titanium reinforced PTFE membrane |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients of both genders requiring implant placement in posterior maxilla
- Age range: 40-60 years.
- Good oral hygiene
- Healthy maxillary sinus free from pathology
- The minimum crestal bone height is (4-6) mm
Key exclusion criteria (12 listed)
- Sinus infection
- Tumors or pathologic lesions in sinus
- Severe allergic rhinitis.
- Chronic topical steroid use.
- Radiation therapy.
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 |
|---|---|---|
| Direct sinus lift with titanium reinforced PTFE membraneImplants will be placed immediately after sinus lifting procedure and maintaining the sinus membrane in position using PTFE titanium reinforced membrane. | Procedure or surgery | Direct Sinus elevation using SLA Kit |
Primary outcome
Change in implant stability
Time frame: at baseline and 6 months
It will be measured using Osstell
Change in bone formation
Time frame: at baseline and 6 months
It will be measured uisng CBCT on Demand 3d software
Change in bone height
Time frame: at baseline and 6 months
It will be measured uisng CBCT on Demand 3d software
Change in bone density
Time frame: at baseline and 6 months
It will be measured uisng CBCT on Demand 3d software
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct sinus lift with titanium reinforced PTFE membrane in people with Sinus Lift, 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 6 inclusion and 12 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 14 Sep 2021. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in implant stability (time frame: at baseline and 6 months). The study lists 4 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 14 Sep 2021.