Crestal Sinus LiftNCT05922592
Different Techniques of Crestal Sinus Lift
A study testing crestal sinus lift using ballon technique and crestal sinus lift using densah burs in people with Crestal Sinus Lift, run by Mansoura University at 1 site in Egypt.
Trial summary
Sixteen patients will be selected from those attending the outpatient clinic of the Oral \& Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University with age range from 20-50 years seeking implantation of their lost posterior maxillary teeth, [premolar and molars] with limited bone height below the… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Crestal Sinus Lift
- What is being tested?
- crestal sinus lift using ballon technique and crestal sinus lift using densah burs
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2022to 1 Jun 2023
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patent ostium of maxillary sinus.
- Patient with missing one or more posterior maxillary teeth.
- A ridge height at the site of implantation of 4-7 mm.
- A ridge width at the site of implantation of 6 mm.
- Good oral hygiene.
- Patients in the age frame between 20 years and 50 years old.
- No gender preface in selection of the patients.
- Acceptable inter-arch space for the future prosthesis.
Who cannot join
- Any pathological condition at the site of surgery.
- Patients with systemic diseases that contra-indicate the surgical procedure such as uncontrolled diabetes mellitus, bleeding disorders, serious osseous disorders, and mental disorders.
- Heavy smoking and alcoholism.
- Parafunctional habits such as bruxism and clenching.
- Signs of acute infection or pus discharge
- Disturbed occlusion.
- Maxillary sinus inflammation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Balloon Technique Versus Densah Bur in Crestal Sinus Lift Operation With Simultaneous Implant Placement. A Prospective Study
Sixteen patients will be selected from those attending the outpatient clinic of the Oral \& Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University with age range from 20-50 years seeking implantation of their lost posterior maxillary teeth, [premolar and molars] with limited bone height below the floor of the maxillary sinus, secondary to sinus pneumatization.
Group I (N = 8): The sinus membrane will be elevated by using balloon technique with simultaneous Implant placement.
Group II (N = 8): The sinus membrane will be elevated by using Densah burs with simultaneous Implant placement.
- Conditions
- Crestal Sinus Lift
- Being tested
- crestal sinus lift using ballon technique, crestal sinus lift using densah burs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
crestal sinus lift using ballon techniqueProcedure or surgery
The sinus membrane will be elevated by using balloon technique with simultaneous Implant placement.
crestal sinus lift using densah bursProcedure or surgery
The sinus membrane will be elevated by using Densah burs with simultaneous Implant placement
| Study group | Role | What they receive |
|---|---|---|
| The sinus membrane will be elevated by using balloon technique with simultaneous Implant placement. | Experimental | Not described Receives: Procedure: crestal sinus lift using ballon technique |
| The sinus membrane will be elevated by using Densah burs with simultaneous Implant placement | Experimental | Not described Receives: Procedure: crestal sinus lift using densah burs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Height gain
Bone height after the surgery measured on CBCT 6-months postoperative _ Residual bone height at implant placement
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start1 Oct 2022
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crestal Sinus LiftStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed mahmoud alajami, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05922592
- Sponsor's protocol ID
- A08030123
- Status last verified
- Jun 2023
- First submitted
- 19 Jun 2023
- Last updated
- 28 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Alajami MM, Elsheikh HA, Abo El-Farag SA, Mansour NA. Antral membrane balloon technique versus Densah bur in crestal sinus lift with simultaneous implant placement: a randomized clinical trial. BMC Oral Health. 2024 Aug 8;24(1):916. doi: 10.1186/s12903-024-04609-8.
PubMed 39118095
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balloon Technique Versus Densah Bur in Crestal Sinus Lift Operation With Simultaneous Implant Placement. A Prospective Study
- ClinicalTrials.gov ID
- NCT05922592
- Acronym / sponsor ID
- A08030123
- Conditions
- Crestal Sinus Lift
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 28 Jun 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.
Sixteen patients will be selected from those attending the outpatient clinic of the Oral \& Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University with age range from 20-50 years seeking implantation of their lost posterior maxillary teeth, [premolar and molars] with limited bone height below the floor of the maxillary sinus, secondary to sinus pneumatization.
Group I (N = 8): The sinus membrane will be elevated by using balloon technique with simultaneous Implant placement.
Group II (N = 8): The sinus membrane will be elevated by using Densah burs with simultaneous Implant placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The sinus membrane will be elevated by using balloon technique with simultaneous Implant placement. | Experimental | Procedure: crestal sinus lift using ballon technique |
| The sinus membrane will be elevated by using Densah burs with simultaneous Implant placement | Experimental | Procedure: crestal sinus lift using densah burs |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patent ostium of maxillary sinus.
- Patient with missing one or more posterior maxillary teeth.
- A ridge height at the site of implantation of 4-7 mm.
- A ridge width at the site of implantation of 6 mm.
- Good oral hygiene.
Key exclusion criteria (7 listed)
- Any pathological condition at the site of surgery.
- Patients with systemic diseases that contra-indicate the surgical procedure such as uncontrolled diabetes mellitus, bleeding disorders, serious osseous disorders, and mental disorders.
- Heavy smoking and alcoholism.
- Parafunctional habits such as bruxism and clenching.
- Signs of acute infection or pus discharge
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 |
|---|---|---|
| crestal sinus lift using ballon techniqueThe sinus membrane will be elevated by using balloon technique with simultaneous Implant placement. | Procedure or surgery | The sinus membrane will be elevated by using balloon technique with simultaneous Implant placement. |
| crestal sinus lift using densah bursThe sinus membrane will be elevated by using Densah burs with simultaneous Implant placement | Procedure or surgery | The sinus membrane will be elevated by using Densah burs with simultaneous Implant placement |
Primary outcome
Height gain
Time frame: 6 months
Bone height after the surgery measured on CBCT 6-months postoperative _ Residual bone height at implant placement
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 28 Jun 2023.
- Derived from this study: PubMed 39118095Alajami MM, Elsheikh HA, Abo El-Farag SA, Mansour NA. Antral membrane balloon technique versus Densah bur in crestal sinus lift with simultaneous implant placement: a randomized clinical trial. BMC Oral Health. 2024 Aug 8;24(1):916. doi: 10.1186/s12903-024-04609-8.
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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 crestal sinus lift using ballon technique and crestal sinus lift using densah burs in people with Crestal Sinus Lift, run by Mansoura 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 8 inclusion and 7 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 28 Jun 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?
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?
Height gain (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05922592, which also lists 1 linked publication.
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 28 Jun 2023.