Marginal Bone LevelsPhase 4NCT06811337
Marginal Bone Changes Around Dental Implant Placed With Open vs. Closed Sinus Elevation
A Phase 4 study testing Open Sinus Elevation and Closed Sinus Elevation in people with Marginal Bone Levels and Open Sinus Elevation, run by Misr International University at 1 site in Egypt.
Trial summary
Background: In cases with atrophic posterior maxilla, sinus elevation techniques are essential for a successful implant placement. The optimal strategy for treating pneumatized maxillary sinus in terms of dental implant insertion and surrounding bone stability has been a scientific conundrum for many years. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Marginal Bone Levels, Open Sinus Elevation, Closed Sinus Elevation
- What is being tested?
- Open Sinus Elevation and Closed Sinus Elevation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 15 Jan 2025
- Phase
- Phase 4
- 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 who have at least one missing posterior maxillary tooth with sound adjacent teeth.
- Adults above the age of 18.
- Bone height from 4mm to 7mm under the maxillary sinus assessed in CBCT.
- Good oral hygiene.
- Patient accepts to sign an informed consent.
Who cannot join
- Smokers (more than 10 cigarettes per day).
- Medically compromised patients.
- Patients with active infection related at the site of implant/bone graft placement.
- Patients with untreated active periodontal diseases.
- Patients with parafunctional habits.
- Acute or chronic sinusitis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 36 - Month Randomized Controlled Trial Comparing the Marginal Bone Changes Surrounding Dental Implants Placed With Open Versus Closed Sinus Elevation and Allogenic Bone Grafting.
Background: In cases with atrophic posterior maxilla, sinus elevation techniques are essential for a successful implant placement. The optimal strategy for treating pneumatized maxillary sinus in terms of dental implant insertion and surrounding bone stability has been a scientific conundrum for many years. The objective of this study was to evaluate and contrast the long-term marginal bone alterations around dental implants that were positioned utilizing transcrestal (closed) versus lateral (open) sinus elevation procedures.
Material and methods:
Fifty six dental implants were inserted for patients with inadequate residual bone height due to maxillary sinus pneumatization after receiving approval from Suez Canal University's ethics council. Depending on the method, these patients were randomly assigned to one of two groups: the test group, which received the closed sinus elevation, or the control group, which received the open sinus elevation.Allogenic bone grafting was used to treat the elevated sinuses in both groups.The mesial and distal marginal bone loss for these dental implants was evaluated over a 12-month period following surgery using a standardized digital periapical radiography and the Cliniview Software to measure radiographic bone alterations.
- Being tested
- Open Sinus Elevation, Closed Sinus Elevation
- Keywords
- Dental Implants, Bone Loss, Maxillary Sinus Floor Augmentation., Bone-Implant Interface, Bone Resorption,
- Medical subject headings
- Bone Diseases, Metabolic, Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open Sinus ElevationProcedure or surgery
Open Sinus Elevation
Closed Sinus ElevationProcedure or surgery
Closed Sinus Elevation
| Study group | Role | What they receive |
|---|---|---|
| Lateral Sinus Elevation | Experimental | Not described Receives: Procedure: Open Sinus Elevation |
| Transcrestal Sinus Elevation | Active comparator | Not described Receives: Procedure: Closed Sinus Elevation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mesial and Distal marginal bone loss
Utilizing A standardized digital periapical radiography, and the Cliniview Software to measure radiographic bone changes mesially and distally to 56 implants placed after sinus elevation in the posterior maxilla.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start1 Jan 2022
- Primary completion15 Jan 2025
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Marginal Bone LevelsStudies 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Misr International University
- Sponsor type
- University, hospital or other
- Collaborators
- Suez Canal University
- Responsible party
- Principal investigator, Hebatallah Abdo's Elsaid Mattar, Misr International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06811337
- Sponsor's protocol ID
- 2021/419
- Status last verified
- Jan 2025
- First submitted
- 19 Jan 2025
- Last updated
- 6 Feb 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 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 36 - Month Randomized Controlled Trial Comparing the Marginal Bone Changes Surrounding Dental Implants Placed With Open Versus Closed Sinus Elevation and Allogenic Bone Grafting.
- ClinicalTrials.gov ID
- NCT06811337
- Acronym / sponsor ID
- 2021/419
- Keywords
- Dental Implants, Bone Loss, Maxillary Sinus Floor Augmentation., Bone-Implant Interface, Bone Resorption,
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Misr International UniversityUniversity, hospital or other
- Collaborators
- Suez Canal University
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 6 Feb 2025 (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.
Background: In cases with atrophic posterior maxilla, sinus elevation techniques are essential for a successful implant placement. The optimal strategy for treating pneumatized maxillary sinus in terms of dental implant insertion and surrounding bone stability has been a scientific conundrum for many years. The objective of this study was to evaluate and contrast the long-term marginal bone alterations around dental implants that were positioned utilizing transcrestal (closed) versus lateral (open) sinus elevation procedures.
Material and methods:
Fifty six dental implants were inserted for patients with inadequate residual bone height due to maxillary sinus pneumatization after receiving approval from Suez Canal University's ethics council. Depending on the method, these patients were randomly assigned to one of two groups: the test group, which received the closed sinus elevation, or the control group, which received the open sinus elevation.Allogenic bone grafting was used to treat the elevated sinuses in both groups.The mesial and distal marginal bone loss for these dental implants was evaluated over a 12-month period following surgery using a standardized digital periapical radiography and the Cliniview Software to measure radiographic bone alterations.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lateral Sinus Elevation | Experimental | Procedure: Open Sinus Elevation |
| Transcrestal Sinus Elevation | Active comparator | Procedure: Closed Sinus Elevation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who have at least one missing posterior maxillary tooth with sound adjacent teeth.
- Adults above the age of 18.
- Bone height from 4mm to 7mm under the maxillary sinus assessed in CBCT.
- Good oral hygiene.
- Patient accepts to sign an informed consent.
Key exclusion criteria (6 listed)
- Smokers (more than 10 cigarettes per day).
- Medically compromised patients.
- Patients with active infection related at the site of implant/bone graft placement.
- Patients with untreated active periodontal diseases.
- Patients with parafunctional habits.
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 ElevationOpen Sinus Elevation | Procedure or surgery | Lateral Sinus Elevation |
| Closed Sinus ElevationClosed Sinus Elevation | Procedure or surgery | Transcrestal Sinus Elevation |
Primary outcome
Mesial and Distal marginal bone loss
Time frame: 3 years
Utilizing A standardized digital periapical radiography, and the Cliniview Software to measure radiographic bone changes mesially and distally to 56 implants placed after sinus elevation in the posterior maxilla.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 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. 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 Phase 4 study testing Open Sinus Elevation and Closed Sinus Elevation in people with Marginal Bone Levels and Open Sinus Elevation, run by Misr International 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 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: finished, as of the sponsor's last update on 6 Feb 2025. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mesial and Distal marginal bone loss (time frame: 3 years). 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 6 Feb 2025.