Bone ResorptionNCT05779345
Stability of Short Implants Versus Standard Blx Implants With Internal Sinus Floor Elevation in Posterior Maxilla
A study testing surgery in people with Bone Resorption, run by Cairo University at 1 site in Egypt.
Trial summary
Implants in the maxillary posterior region are associated with compromised bone in both quantity - notably in vertical dimension- and quality. Along with the fact that the posterior teeth are subjected to higher occlusal forces than the anterior teeth (Marianne Morand \& Tassos Irinakis, 2007). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Resorption
- What is being tested?
- surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Mar 2023to 2 Jul 2025
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Single edentuolous site at maxillary posterior region
- The available bone height below the maxillary sinus should be 7-8mm
- Patients ≥ 20 years old
- Bucco-palatal bone width should be ≥6mm
- Adequate interarch space
- Bounded, single
Who cannot join
- Patients with local pathological defects related to the area of interest.
- Patients with habits that may jeopardize the implant longevity and affect the results of the study such as alcoholism or parafunctional habits.
- Inadequate inter-arch space for implant prosthetic part
- Smokers
- pregnancy
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, Greater Cairo, 12613
Hani El Nahass, Professor
About this study
Official title: Clinical and Radiographic Evaluation of Stability of Short Implants Versus Standard Blx Implants Placed With Internal Sinus Floor Elevation in Posterior Maxilla: A Randomized Controlled Clinical Trial
Implants in the maxillary posterior region are associated with compromised bone in both quantity - notably in vertical dimension- and quality. Along with the fact that the posterior teeth are subjected to higher occlusal forces than the anterior teeth (Marianne Morand \& Tassos Irinakis, 2007). In order to overcome these shortcomings, various procedures have been advocated including open and closed sinus lift (Nkenke E \& Stelzle F, 2009; Schropp et al, 2003). The use of short implants is a valid alternative for these procedures (Wallace SS \& Froum SJ, 2003) sparing the need of applying augmentation techniques with the associated increased time, morbidity and complexity of such procedures.
Read the detailed description
To overcome anatomical and physiological limitations, different sinus augmentation techniques with immediate or delayed (6-8 months post augmentation) implant placement have been proposed. The most common one is the sinus elevation with a lateral window approach. Although these protocols evoke a high level of success in augmenting the bone quantity (Nkenke E \& Stelzle F, 2009; Schropp et al, 2003) many patients refuse them because of the invasiveness of the augmentative procedure, with obvious prolonged healing times and increased morbidity and costs (Fugazzotto, 2003; Bra¨gger et al, 2004; Toffler, 2004). An alternative therapy for restoring areas of limited bone dimension is the placement of short implants (Wallace SS \& Froum SJ, 2003). ''Standard length implants'' are those of 10 mm in length and have been defined as the minimal length for anticipated success (Griffin TJ \& Cheung WS, 2004).
- Conditions
- Bone Resorption
- Being tested
- surgery
- Medical subject headings
- Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgeryProcedure or surgery
short implant placement
| Study group | Role | What they receive |
|---|---|---|
| short implants | Active comparator | short 6 mm straumann blx implants Receives: Procedure: surgery |
| regular length + internal sinus lift | Active comparator | regular length implant 10 mm, in addition to internal sinus lift procedure Receives: Procedure: surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
crestal bone level
crestal bone level will be assessed by periapical standardized radiographs
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start2 Mar 2023
- Primary completion2 Apr 2025 (estimated)
- Study completion2 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone ResorptionStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hani Elnahass, Cairo University
- Investigators
- Hani El Nahass, Professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05779345
- Sponsor's protocol ID
- 00
- Status last verified
- Dec 2023
- First submitted
- 10 Mar 2023
- Last updated
- 15 Dec 2023
- 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 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Stability of Short Implants Versus Standard Blx Implants Placed With Internal Sinus Floor Elevation in Posterior Maxilla: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05779345
- Acronym / sponsor ID
- 00
- Conditions
- Bone Resorption
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 Mar 2023 (actual)
- Primary completion
- 2 Apr 2025 (estimated)
- Study completion
- 2 Jul 2025 (estimated)
- First posted
- 22 Mar 2023 (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.
Implants in the maxillary posterior region are associated with compromised bone in both quantity - notably in vertical dimension- and quality. Along with the fact that the posterior teeth are subjected to higher occlusal forces than the anterior teeth (Marianne Morand \& Tassos Irinakis, 2007). In order to overcome these shortcomings, various procedures have been advocated including open and closed sinus lift (Nkenke E \& Stelzle F, 2009; Schropp et al, 2003). The use of short implants is a valid alternative for these procedures (Wallace SS \& Froum SJ, 2003) sparing the need of applying augmentation techniques with the associated increased time, morbidity and complexity of such procedures.
Detailed description
To overcome anatomical and physiological limitations, different sinus augmentation techniques with immediate or delayed (6-8 months post augmentation) implant placement have been proposed. The most common one is the sinus elevation with a lateral window approach. Although these protocols evoke a high level of success in augmenting the bone quantity (Nkenke E \& Stelzle F, 2009; Schropp et al, 2003) many patients refuse them because of the invasiveness of the augmentative procedure, with obvious prolonged healing times and increased morbidity and costs (Fugazzotto, 2003; Bra¨gger et al, 2004; Toffler, 2004). An alternative therapy for restoring areas of limited bone dimension is the placement of short implants (Wallace SS \& Froum SJ, 2003). ''Standard length implants'' are those of 10 mm in length and have been defined as the minimal length for anticipated success (Griffin TJ \& Cheung WS, 2004).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| short implants | Active comparator | Procedure: surgeryshort 6 mm straumann blx implants |
| regular length + internal sinus lift | Active comparator | Procedure: surgeryregular length implant 10 mm, in addition to internal sinus lift procedure |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Single edentuolous site at maxillary posterior region
- The available bone height below the maxillary sinus should be 7-8mm
- Patients ≥ 20 years old
- Bucco-palatal bone width should be ≥6mm
- Adequate interarch space
Key exclusion criteria (5 listed)
- Patients with local pathological defects related to the area of interest.
- Patients with habits that may jeopardize the implant longevity and affect the results of the study such as alcoholism or parafunctional habits.
- Inadequate inter-arch space for implant prosthetic part
- Smokers
- pregnancy
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 |
|---|---|---|
| surgeryshort implant placement | Procedure or surgery | regular length + internal sinus lift, short implants |
Primary outcome
crestal bone level
Time frame: 1 year
crestal bone level will be assessed by periapical standardized radiographs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
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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.
Hani El Nahass, Professor study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surgery in people with Bone Resorption, 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 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 15 Dec 2023. 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 Suzy Naiem, MSc (+201224785645, suzy.naiem@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
crestal bone level (time frame: 1 year). 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 15 Dec 2023.