Sinus ElevationNCT06207604
Implant Placement Using Open Sinus Elevation Technique With and Without Bone Grafting Material
A study testing Open sinus lifting without bone grafting and simultaneous implant placement and Open sinus lifting with bone grafting and simultaneous implant placement in people with Sinus Elevation, run by Misr International University.
Trial summary
The success rate of dental implants after graftless sinus augmentation versus conventional sinus augmentation surgery in atrophic maxillae in edentulous patients was investigated and it was concluded that despite the bone gain in ten garftless side, implant survival were significantly lower in the non-grafted side. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sinus Elevation
- What is being tested?
- Open sinus lifting without bone grafting and simultaneous implant placement and Open sinus lifting with bone grafting and simultaneous implant placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Edentulous atrophic posterior maxillary ridge.
- Residual alveolar ridge height within 3-5mm.
- At least 2mm band of keratinized tissue.
- Patients with good oral hygiene.
- Compliant patients to the follow up periods.
Who cannot join
- Medically compromised patients.
- Smokers.
- Pregnant females.
- Patients with active periodontal disease.
- Bruxer patients.
- Patients with chronic or active sinusitis.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Survivability of Dental Implants Placed in Atrophic Maxillae Using Open Sinus Elevation Technique With and Without Bone Grafting Material. A Randomized Controlled Clinical Trial
The success rate of dental implants after graftless sinus augmentation versus conventional sinus augmentation surgery in atrophic maxillae in edentulous patients was investigated and it was concluded that despite the bone gain in ten garftless side, implant survival were significantly lower in the non-grafted side. One year later, Lie et al., conducted a systematic review to evaluate efficacy of graftless maxillary sinus membrane elevation using the lateral window approach for implantation in the atrophic maxilla. It showed a high implant survival rate in non-grafted maxillary sinus lifts and conventional sinus lifts using augmentation materials and there was no significant difference in the ISQ values between both procedures. However, further randomized clinical trials with long-term follow-up were recommended.
Read the detailed description
It is well documented in literature that after dental extractions, the alveolar ridge will undergo some changes in volume both in hard and soft tissue both in the anterior and posterior region of the oral cavity. This adds challenges to properly place dental implants following tooth extraction in a good prosthetic position, specifically in the Maxillary posterior region due to the proximity of the Maxillary Sinus. Maxillary sinus pneumatization is an ongoing process that occurs naturally causing increased maxillary sinus volume on the expense of the alveolar ridge. When the combination of sinus pneumatization and bony atrophy of the maxilla occurs following tooth extractions together over time, the edentulous ridge dimension can be very minimal.
Numerous techniques were suggested to facilitate implant placement in atrophic posterior maxilla. The first proposed technique was the Maxillary Open sinus technique, it was first proposed by Dr. O. Hilt Tatum at an implant meeting in Alabama, however, Boyne and James in 1980 were the first to publish this surgical technique. In order to regain the vertical dimension, open sinus technique was originally performed in a staged manner over two steps, where the implant was placed after a healing period after Maxillary sinus augmentation, however, the different sinus elevation techniques, whether staged or one step did not seem to affect the implant success rate and showed bone gain of up to 12 mm.
Some authors suggested less invasive techniques that were of less discomfort to the patient, more cost effective and less time consuming. Summers proposed the osteotome technique, where similar to traditional drilling, an osteotomy is prepared using a set of osteotomes 1mm short of the sinus floor, followed by fracturing of the floor using the proper sized osteotome with bone graft material, which will allow the introduction of bone grafting material into the sinus floor, followed by the placement of the dental implant. However it was limited to 5 mm in terms of bone gain compared to 12 mm bone gain in the open sinus technique. Over the years, modifications to Summers original technique were made. Short dental implants were proposed; however, a review of the literature reveals implants shorter than 10 mm often have a higher failure rate than longer implants. These complications may be related to an increase in crown height, higher bite forces in the posterior regions, and less bone density. As a result, methods to decrease stresses to the bone-implant interface are to be researched. This necessitates and puts the clinician in a situation where the open sinus procedure is sometimes inevitable.
The formation of bone in elevated sinus space was a mystery and its reason was unknown. However a histological study showed the osteogenic potential of the Schneiderian membrane when it was subcutaneously placed in rats suggesting that bone genesis could be directly related to the presence of the Schneiderian membrane in the maxillary sinus regardless the presence or absence of a bone grafting material. This technique was based on the concept that the lifting of the sinus membrane and the establishment of a compartment with a blood clot could result in new bone around the inserted implants in a similar way that bone-graft materials maintain the augmented space and promote osteogenesis.
- Conditions
- Sinus Elevation
- Being tested
- Open sinus lifting without bone grafting and simultaneous implant placement, Open sinus lifting with bone grafting and simultaneous implant placement
- Keywords
- dental implants, bone grafting, posterior maxilla
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open sinus lifting without bone grafting and simultaneous implant placementProcedure or surgery
no bone graft will be used after open sinus lifting
Open sinus lifting with bone grafting and simultaneous implant placementProcedure or surgery
bone graft will be packed palatally after open sinus elevation and before implant placement, then implant placement will took place followed by packing of bone grafts
| Study group | Role | What they receive |
|---|---|---|
| Open sinus lifting without bone grafting and simultaneous implant placement | Experimental | When adequate release of the membrane is achieved and deemed enough by the operator, an osteotomy is created in the edentulous area following the drilling sequence provided by the implant system used. the implant placement is done directly with the implant motor and the use of a hand driver if needed to adjust the implant platform relation to the crestal bone, followed by cover screw placement. Receives: Procedure: Open sinus lifting without bone grafting and simultaneous implant placement |
| Open sinus lifting with bone grafting and simultaneous implant placement | Active comparator | When adequate release of the membrane is achieved and deemed enough by the operator, an osteotomy is created in the edentulous area following the drilling sequence provided by the implant system used. the palatal packing of bone is made before the implant placement, as the palatal aspect of the sinus will be inaccessible after placement of the implant, the implant placement is done directly with the implant motor and the use of a hand driver if needed to adjust the implant platform relation to the crestal bone, followed by cover screw placement. Receives: Procedure: Open sinus lifting with bone grafting and simultaneous implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long- term Implant Stability
Resonance frequency analysis will be employed with a dedicated device (Osstell).
Measured: 12 months
Secondary outcomes (2)
Implant survivability
Individual unattached implant that is immobile when tested clinically, radiography that does not demonstrate evidence of peri-implant radiolucency, Bone loss that is less than 0.2 mm annually after the implant's first year of service, No persistent pain, discomfort or infection
Measured: 12 months
Vertical bone height formed
CBCTS
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start1 Aug 2025 (estimated)
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sinus ElevationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Misr International University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abo El Futtouh, Misr International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06207604
- Sponsor's protocol ID
- IDCE.N8
- Status last verified
- Apr 2025
- First submitted
- 17 Dec 2023
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survivability of Dental Implants Placed in Atrophic Maxillae Using Open Sinus Elevation Technique With and Without Bone Grafting Material. A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06207604
- Acronym / sponsor ID
- IDCE.N8
- Conditions
- Sinus Elevation
- Keywords
- dental implants, bone grafting, posterior maxilla
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Misr International UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 17 Jan 2024 (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.
The success rate of dental implants after graftless sinus augmentation versus conventional sinus augmentation surgery in atrophic maxillae in edentulous patients was investigated and it was concluded that despite the bone gain in ten garftless side, implant survival were significantly lower in the non-grafted side. One year later, Lie et al., conducted a systematic review to evaluate efficacy of graftless maxillary sinus membrane elevation using the lateral window approach for implantation in the atrophic maxilla. It showed a high implant survival rate in non-grafted maxillary sinus lifts and conventional sinus lifts using augmentation materials and there was no significant difference in the ISQ values between both procedures. However, further randomized clinical trials with long-term follow-up were recommended.
Detailed description
It is well documented in literature that after dental extractions, the alveolar ridge will undergo some changes in volume both in hard and soft tissue both in the anterior and posterior region of the oral cavity. This adds challenges to properly place dental implants following tooth extraction in a good prosthetic position, specifically in the Maxillary posterior region due to the proximity of the Maxillary Sinus. Maxillary sinus pneumatization is an ongoing process that occurs naturally causing increased maxillary sinus volume on the expense of the alveolar ridge. When the combination of sinus pneumatization and bony atrophy of the maxilla occurs following tooth extractions together over time, the edentulous ridge dimension can be very minimal.
Numerous techniques were suggested to facilitate implant placement in atrophic posterior maxilla. The first proposed technique was the Maxillary Open sinus technique, it was first proposed by Dr. O. Hilt Tatum at an implant meeting in Alabama, however, Boyne and James in 1980 were the first to publish this surgical technique. In order to regain the vertical dimension, open sinus technique was originally performed in a staged manner over two steps, where the implant was placed after a healing period after Maxillary sinus augmentation, however, the different sinus elevation techniques, whether staged or one step did not seem to affect the implant success rate and showed bone gain of up to 12 mm.
Some authors suggested less invasive techniques that were of less discomfort to the patient, more cost effective and less time consuming. Summers proposed the osteotome technique, where similar to traditional drilling, an osteotomy is prepared using a set of osteotomes 1mm short of the sinus floor, followed by fracturing of the floor using the proper sized osteotome with bone graft material, which will allow the introduction of bone grafting material into the sinus floor, followed by the placement of the dental implant. However it was limited to 5 mm in terms of bone gain compared to 12 mm bone gain in the open sinus technique. Over the years, modifications to Summers original technique were made. Short dental implants were proposed; however, a review of the literature reveals implants shorter than 10 mm often have a higher failure rate than longer implants. These complications may be related to an increase in crown height, higher bite forces in the posterior regions, and less bone density. As a result, methods to decrease stresses to the bone-implant interface are to be researched. This necessitates and puts the clinician in a situation where the open sinus procedure is sometimes inevitable.
The formation of bone in elevated sinus space was a mystery and its reason was unknown. However a histological study showed the osteogenic potential of the Schneiderian membrane when it was subcutaneously placed in rats suggesting that bone genesis could be directly related to the presence of the Schneiderian membrane in the maxillary sinus regardless the presence or absence of a bone grafting material. This technique was based on the concept that the lifting of the sinus membrane and the establishment of a compartment with a blood clot could result in new bone around the inserted implants in a similar way that bone-graft materials maintain the augmented space and promote osteogenesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open sinus lifting without bone grafting and simultaneous implant placement | Experimental | Procedure: Open sinus lifting without bone grafting and simultaneous implant placementWhen adequate release of the membrane is achieved and deemed enough by the operator, an osteotomy is created in the edentulous area following the drilling sequence provided by the implant system used. the implant placement is done directly with the implant motor and the use of a hand driver if needed to adjust the implant platform relation to the crestal bone, followed by cover screw placement. |
| Open sinus lifting with bone grafting and simultaneous implant placement | Active comparator | Procedure: Open sinus lifting with bone grafting and simultaneous implant placementWhen adequate release of the membrane is achieved and deemed enough by the operator, an osteotomy is created in the edentulous area following the drilling sequence provided by the implant system used. the palatal packing of bone is made before the implant placement, as the palatal aspect of the sinus will be inaccessible after placement of the implant, the implant placement is done directly with the implant motor and the use of a hand driver if needed to adjust the implant platform relation to the crestal bone, followed by cover screw placement. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Edentulous atrophic posterior maxillary ridge.
- Residual alveolar ridge height within 3-5mm.
- At least 2mm band of keratinized tissue.
- Patients with good oral hygiene.
- Compliant patients to the follow up periods.
Key exclusion criteria (6 listed)
- Medically compromised patients.
- Smokers.
- Pregnant females.
- Patients with active periodontal disease.
- Bruxer patients.
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 |
|---|---|---|
| Open sinus lifting without bone grafting and simultaneous implant placementno bone graft will be used after open sinus lifting | Procedure or surgery | Open sinus lifting without bone grafting and simultaneous implant placement |
| Open sinus lifting with bone grafting and simultaneous implant placementbone graft will be packed palatally after open sinus elevation and before implant placement, then implant placement will took place followed by packing of bone grafts | Procedure or surgery | Open sinus lifting with bone grafting and simultaneous implant placement |
Primary outcome
Long- term Implant Stability
Time frame: 12 months
Resonance frequency analysis will be employed with a dedicated device (Osstell).
2 secondary outcomes
Implant survivability
Time frame: 12 months
Vertical bone height formed
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Open sinus lifting without bone grafting and simultaneous implant placement and Open sinus lifting with bone grafting and simultaneous implant placement in people with Sinus Elevation, run by Misr International University.
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 5 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: opening soon, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed I Abo El Futtouh, Dr (+201019999983, ahmedkey7@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long- term Implant Stability (time frame: 12 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 18 Apr 2025.