Bone Formation Around Implant After Crestal Sinus LiftingPhase 1NCT05166434
Assessment Crestal Maxillary Sinus Membrane Elevation Using Different Implant Heights
A Phase 1 study testing trans-crestal sinus lifting in people with Bone Formation Around Implant After Crestal Sinus Lifting, run by Cairo University at 1 site in Egypt.
Trial summary
This study is aiming to evaluate primary stability and bone gain in trans-crestal osseodencification technique using Regular concaved osteotomes at different height elevations. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bone Formation Around Implant After Crestal Sinus Lifting
- What is being tested?
- trans-crestal sinus lifting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2021to 1 May 2022
- Phase
- Phase 1
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with edentulous vertically deficient posterior maxillary ridge a minimum 4 mm height of alveolar bone, and 6 mm in width.
- Both males as well as females without any active periodontal disease.
- All patients are in a good health with no systemic, immunologic or debilitating diseases that could affect normal bone healing.
- All selected patients are non-smokers and non-alcoholics.
- Patients are free from T.M.J troubles, abnormal oral habits such as bruxism.
- The edentulous ridges are covered with optimal thickness of mucoperiosteum with no signs of inflammation, ulceration or scar tissue.
- Remaining natural teeth have good periodontal tissue support and occlusion showed sufficient inter arch space for future prosthesis.
Who cannot join
- On the local level, patients with maxillary sinus diseases, former sinus surgery and unfavorable inter maxillary relationship will be excluded.
- General contraindications to implant surgery.
- Subjected to irradiation in the head and neck area less than 1 year before implantation.
- Untreated periodontitis.
- Poor oral hygiene and motivation.
- Uncontrolled diabetes.
Show all 19Show fewer
- Pregnant or nursing.
- Substance abuse.
- Psychiatric problems or unrealistic expectations.
- Severe bruxism or clenching.
- Immunosuppressed or immunocompromised.
- Treated or under treatment with intravenous amino-bisphosphonates.
- Lack of opposite occluding dentition/prosthesis in the area intended for implant placement.
- Active infection or severe inflammation in the area intended for implant placement.
- Need of bone augmentation procedures at implant placement.
- Unable to open mouth sufficiently to accommodate the surgical tooling.
- Patients participating in other studies, if the present protocol could not be properly followed.
- Referred only for implant placement or unable to attend a 5-year follow-up.
- Requiring only single implant-supported crowns.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Maher Mohammed Hebah Maqbol
Cairo, Giza Governorate, 11553
Mohammad m Khashaba, PHD, 01227754765 ext. 0020, mohammedkhashaba@hotmail.com
Mohammad m Atef, PHD
About this study
Official title: Radiographic Assessment of Crestal Maxillary Sinus Membrane Elevation Using Different Dental Implant Heights in Atrophic Posterior Maxilla
This study is aiming to evaluate primary stability and bone gain in trans-crestal osseodencification technique using Regular concaved osteotomes at different height elevations.
Read the detailed description
For those patient who need up to 2-6 mm of vertical height, the 1-stage transcrestal osteotome technique shown to be stable over long term.
The most important negative factor that can be inferred from the results is that BAOSFE becomes less predictable when there is 4 mm or less of preexisting alveolar bone height beneath the sinus. Moreover, more challenging situation is the magnitude of tapping force, which may accidently perforate the antral membrane causing a lot of complication in the naso-antral apparatus by excessive taping force. The expansion of the osteotomy sites is performed with a number of Concave tipped tapered osteotomes with increasing diameters that are applied through the edentulous alveolar crest at the inferior border of the maxillary sinus floor. With each insertion of a larger osteotome, bone is compressed, pushed laterally and apically while pushing the garnered bone apically beneath the tented membrane.
- Being tested
- trans-crestal sinus lifting
- Keywords
- Stability, implant. sinus lifting, bone formation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trans-crestal sinus liftingProcedure or surgery
Also called Closed sinus lifting
this study will be divided in to three different groups, each group will receive a same technique of Crestal maxillary sinus lifting and implant placement at 2,4,6 mm heights.
| Study group | Role | What they receive |
|---|---|---|
| bone formation around implant at 2mm membrane elevation crestal sinus lifting | Active comparator | Not described Receives: Procedure: trans-crestal sinus lifting |
| bone formation around implant at 4mm membrane elevation crestal sinus lifting | Active comparator | Not described Receives: Procedure: trans-crestal sinus lifting |
| bone formation around implant at 6mm membrane elevation crestal sinus lifting | Active comparator | Not described Receives: Procedure: trans-crestal sinus lifting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring bone formation and density beyond apical part of dental implant after closed sinus lifting
CBCT superimposition of the Pre-operative and Post-operative
Measured: 4 months after Dental implant placement
Secondary outcomes (1)
Measuring secondary stability of dental implants
osttell device (ISQ)
Measured: 4 months after Dental implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start1 Oct 2021
- Primary completion20 Dec 2021
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Formation Around Implant After Crestal Sinus LiftingStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maher Mohammed Hebah Maqbol, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05166434
- Sponsor's protocol ID
- o m f s 335
- Status last verified
- Dec 2021
- First submitted
- 7 Dec 2021
- Last updated
- 22 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiographic Assessment of Crestal Maxillary Sinus Membrane Elevation Using Different Dental Implant Heights in Atrophic Posterior Maxilla
- ClinicalTrials.gov ID
- NCT05166434
- Acronym / sponsor ID
- o m f s 335
- Keywords
- Stability, implant. sinus lifting, bone formation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 22 Dec 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.
This study is aiming to evaluate primary stability and bone gain in trans-crestal osseodencification technique using Regular concaved osteotomes at different height elevations.
Detailed description
For those patient who need up to 2-6 mm of vertical height, the 1-stage transcrestal osteotome technique shown to be stable over long term.
The most important negative factor that can be inferred from the results is that BAOSFE becomes less predictable when there is 4 mm or less of preexisting alveolar bone height beneath the sinus. Moreover, more challenging situation is the magnitude of tapping force, which may accidently perforate the antral membrane causing a lot of complication in the naso-antral apparatus by excessive taping force. The expansion of the osteotomy sites is performed with a number of Concave tipped tapered osteotomes with increasing diameters that are applied through the edentulous alveolar crest at the inferior border of the maxillary sinus floor. With each insertion of a larger osteotome, bone is compressed, pushed laterally and apically while pushing the garnered bone apically beneath the tented membrane.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| bone formation around implant at 2mm membrane elevation crestal sinus lifting | Active comparator | Procedure: trans-crestal sinus lifting |
| bone formation around implant at 4mm membrane elevation crestal sinus lifting | Active comparator | Procedure: trans-crestal sinus lifting |
| bone formation around implant at 6mm membrane elevation crestal sinus lifting | Active comparator | Procedure: trans-crestal sinus lifting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with edentulous vertically deficient posterior maxillary ridge a minimum 4 mm height of alveolar bone, and 6 mm in width.
- Both males as well as females without any active periodontal disease.
- All patients are in a good health with no systemic, immunologic or debilitating diseases that could affect normal bone healing.
- All selected patients are non-smokers and non-alcoholics.
- Patients are free from T.M.J troubles, abnormal oral habits such as bruxism.
Key exclusion criteria (19 listed)
- On the local level, patients with maxillary sinus diseases, former sinus surgery and unfavorable inter maxillary relationship will be excluded.
- General contraindications to implant surgery.
- Subjected to irradiation in the head and neck area less than 1 year before implantation.
- Untreated periodontitis.
- Poor oral hygiene and motivation.
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 |
|---|---|---|
| trans-crestal sinus liftingAlso: Closed sinus liftingthis study will be divided in to three different groups, each group will receive a same technique of Crestal maxillary sinus lifting and implant placement at 2,4,6 mm heights. | Procedure or surgery | bone formation around implant at 2mm membrane elevation crestal sinus lifting, bone formation around implant at 4mm membrane elevation crestal sinus lifting, bone formation around implant at 6mm membrane elevation crestal sinus lifting |
Primary outcome
Measuring bone formation and density beyond apical part of dental implant after closed sinus lifting
Time frame: 4 months after Dental implant placement
CBCT superimposition of the Pre-operative and Post-operative
1 secondary outcome
Measuring secondary stability of dental implants
Time frame: 4 months after Dental implant placement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2021.
- Individual participant dataSharing planned: No
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 Phase 1 study testing trans-crestal sinus lifting in people with Bone Formation Around Implant After Crestal Sinus Lifting, 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 7 inclusion and 19 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 22 Dec 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Maher mohammad Maqbol, BDS (01141722802 ext. 0020, maher.maqbol@dentistry.cu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring bone formation and density beyond apical part of dental implant after closed sinus lifting (time frame: 4 months after Dental implant placement). 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 22 Dec 2021.