Sinus PneumatizationNCT07329179
Crestal Sinus Lifting Using Densah Burs Versus Lateral Window Technique at Residual Alveolar Ridge Height 3-5 mm With Simultaneous Implant Placement
A study testing crestal sinus lifting using densah burs and sinus lifting using lateral window technique in people with Sinus Pneumatization, run by Delta University for Science and Technology at 1 site in Egypt.
Trial summary
The aim of the study was to assess the clinical and radiographic outcomes of crestal sinus lifting using densah burs versus lateral window technique in vertically deficient posterior maxilla with simultaneous implant placement. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Sinus Pneumatization
- What is being tested?
- crestal sinus lifting using densah burs and sinus lifting using lateral window technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Feb 2023to 20 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1. Patient medically free from systemic, immunologic or debilitating diseases or local conditions that could affect normal bone healing and/or implant placement.
- 2. Patient with good oral hygiene. 3. Age from 18 to 55 years. 4. Partially edentulous patients with missed one or more of maxillary posterior teeth with residual alveolar ridge height 3-5 mm and a minimal width of the alveolar ridge 7 mm in the region of the planned implant site.
- 5. Patients' edentulous ridges covered with optimal width of keratinized mucosa (<3 mm) with no signs of inflammation, ulceration of scar tissue.
- 6. No history of parafunctional habits. 7. Patients were ready to comply with the follow-up and maintenance program. 8. Sufficient inter arch space for prothesis.
Who cannot join
- 1. Patients with clinical or radiographic evidence of rhinosinusitis or any other pathology in the maxillary sinus.
- 2. Smokers. 3. Pregnancy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Mansoura University
Al Mansurah, Dakahlia Governorate
About this study
The aim of the study was to assess the clinical and radiographic outcomes of crestal sinus lifting using densah burs versus lateral window technique in vertically deficient posterior maxilla with simultaneous implant placement.
- Conditions
- Sinus Pneumatization
- Being tested
- crestal sinus lifting using densah burs, sinus lifting using lateral window technique
- Keywords
- Densah burs, CBCT, Sinus lifting, Implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
crestal sinus lifting using densah bursProcedure or surgery
- Crestal flap was made.
- 2 mm densah bur was used first as a pilot drill in clockwise direction and stopped 1 mm before sinus floor. Implant surgical motor setting was changed to reverse.
- The next wider densah bur (3.00 mm) was used and advanced into the previous created osteotomy. When feeling the haptic feedback of the bur reaching the dense sinus floor, pressure was modulated with a pumping motion to advance past the sinus floor in 1 mm increments, up to 3 mm.
- The sequential wider densah burs were used in densifing mode with copious irrigation with pumping motion to achieve additional width with maximum membrane lift of 3 mm to reach final desired width for implant placement.
- The osteotomy was filled with a well hydrated, xenograft. The last densah bur was used in densifing mode with low speed 150-200 rpm with no irrigation.
- The implant was placed into the osteotomy.
sinus lifting using lateral window techniqueProcedure or surgery
Also called lateral sinus lifting
- Trapezoidal flap was made and full thickness mucoperiosteal flap was raised to visualize the lateral side of the maxilla. (Fig. 23)
- Complete osteotomy of lateral window was made to gain access to the Schneiderian membrane using piezosurgery unit to minimize the probability of membrane perforation with round tip (SL3).
- Sinus membrane elevators were used carefully to free up sinus membrane in all directions (mesially, distally and medially).
- The membrane at the inferior aspect of the osteotomy was dissected from the floor of the maxillary sinus and elevated upward to create a space in the floor of the sinus for the bone graft material.
- Drilling of the implant was done using surgical implant kit while using periosteal elevators to protect schniderian membrane.
- Bone graft was packed under the membrane in all directions with the help of pluggers till reach the medial wall of the maxillary sinus.
- Implant was placed and the lateral osteotomy was covered with collagen membrane
| Study group | Role | What they receive |
|---|---|---|
| crestal technique using densah burs | Experimental | Seven implant sites underwent sinus membrane elevation procedure using densah burs with crestal approach. Crestal flap was made and Densah bur with diameter 2.00 mm will be used in osseodensification mode with copious irrigation till sinus floor, then diameter 3.00 mm bur up to 3 mm past the sinus floor, then sequential wider burs to reach the final desired width followed by bone grafting and simultaneous implant placement. Receives: Procedure: crestal sinus lifting using densah burs |
| lateral window technique | Active comparator | Seven implant sites underwent sinus membrane elevation procedure using lateral window technique. Pyramidal flap was made and an trap door is created in the lateral sinus wall to gain access to Schneiderian membrane in order to elevate it and provide space for the bone graft material to be placed followed by simultaneous implant placement. Receives: Procedure: sinus lifting using lateral window technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in pain, as measured by Numerical Rating Scale (NRS)
Pain was evaluated postoperatively at the day of surgery, 3rd and 7th day post-surgically Numerical Rating Scale (NRS). Numerical Rating Scale (NRS) is a simple, widely used tool, typically an 11-point scale (0-10), where patients rate their pain intensity, with 0 meaning "no pain" and 10 meaning "worst imaginable pain,".
Measured: Baseline, 7 days
change from baseline of edema
Edema was evaluated with the aid of tape measure (in centimeters). Three measurements were performed on the patient's operated site preoperatively, 3rd and 7th day after surgery. The evaluation of edema was done by subtracting the total value of the three measurements obtained postoperatively (at 3rd and 7th day) from the total value of the three measurements obtained at pre-operative baseline.
The three measuring lines are:
- Lateral corner of the eye-angle of the mandible.
- Tragus-outer corner of the mouth.
- Tragus pogonion.
Measured: baseline, 7 days
change of implant stability, as measured by osstell
Stability was measured with osstell (ISQ) immediately after implant placement (T0) after 12 months (T12). ISQ is a scale that ranges from 1 to 100 and is used to assess implant stability. Scales greater than 70 ISQ indicate a high level of stability, scales between 60 and 69 means medium stability and scales >60 ISQ are considered as low stability.
Measured: baseline, 12 months
change from baseline in Grafted sinus height (GSH)
CBCT was made preoperatively, immediately after sinus augmentation (T0) and 6 months after loading (T12) for evaluation of Grafted sinus height (GSH): the distance between the original sinus floor to the new sinus floor regarding crestal cortical line.
Measured: baseline, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start5 Feb 2023
- Primary completion13 Apr 2025
- Study completion20 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sinus PneumatizationStudies 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
- Model description
- The patients were divided randomly into two equal groups; each included 7 implants: \- For group I: Sinus membrane elevation procedure using densah burs with crestal approach followed by bone grafting and simultaneous implant placement were done in this group. \- For group II: Sinus membrane elevation procedure using lateral window technique followed by bone grafting and simultaneous implant placement were done in this group.
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Delta University for Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Mansoura University
- Responsible party
- Sponsor
- Investigators
- Wael Mohamed Ahmed, professor, Study director, department of oral and maxillofacial surgery, faculty of dentistry, mansoura university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07329179
- Sponsor's protocol ID
- A02061222
- Status last verified
- Dec 2025
- First submitted
- 29 Dec 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Crestal Sinus Lifting Using Densah Burs Versus Lateral Window Technique at Residual Alveolar Ridge Height 3-5 mm With Simultaneous Implant Placement
- ClinicalTrials.gov ID
- NCT07329179
- Acronym / sponsor ID
- A02061222
- Conditions
- Sinus Pneumatization
- Keywords
- Densah burs, CBCT, Sinus lifting, Implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Delta University for Science and TechnologyUniversity, hospital or other
- Collaborators
- Mansoura University
- Study start
- 5 Feb 2023 (actual)
- Primary completion
- 13 Apr 2025 (actual)
- Study completion
- 20 Jul 2025 (actual)
- First posted
- 9 Jan 2026 (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 aim of the study was to assess the clinical and radiographic outcomes of crestal sinus lifting using densah burs versus lateral window technique in vertically deficient posterior maxilla with simultaneous implant placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The patients were divided randomly into two equal groups; each included 7 implants: - For group I: Sinus membrane elevation procedure using densah burs with crestal approach followed by bone grafting and simultaneous implant placement were done in this group. - For group II: Sinus membrane elevation procedure using lateral window technique followed by bone grafting and simultaneous implant placement were done in this group.
| Arm | Type | Receives |
|---|---|---|
| crestal technique using densah burs | Experimental | Procedure: crestal sinus lifting using densah bursSeven implant sites underwent sinus membrane elevation procedure using densah burs with crestal approach. Crestal flap was made and Densah bur with diameter 2.00 mm will be used in osseodensification mode with copious irrigation till sinus floor, then diameter 3.00 mm bur up to 3 mm past the sinus floor, then sequential wider burs to reach the final desired width followed by bone grafting and simultaneous implant placement. |
| lateral window technique | Active comparator | Procedure: sinus lifting using lateral window techniqueSeven implant sites underwent sinus membrane elevation procedure using lateral window technique. Pyramidal flap was made and an trap door is created in the lateral sinus wall to gain access to Schneiderian membrane in order to elevate it and provide space for the bone graft material to be placed followed by simultaneous implant placement. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 1. Patient medically free from systemic, immunologic or debilitating diseases or local conditions that could affect normal bone healing and/or implant placement.
- 2. Patient with good oral hygiene. 3. Age from 18 to 55 years. 4. Partially edentulous patients with missed one or more of maxillary posterior teeth with residual alveolar ridge height 3-5 mm and a minimal width of the alveolar ridge 7 mm in the region of the planned implant site.
- 5. Patients' edentulous ridges covered with optimal width of keratinized mucosa (<3 mm) with no signs of inflammation, ulceration of scar tissue.
- 6. No history of parafunctional habits. 7. Patients were ready to comply with the follow-up and maintenance program. 8. Sufficient inter arch space for prothesis.
Key exclusion criteria (2 listed)
- 1. Patients with clinical or radiographic evidence of rhinosinusitis or any other pathology in the maxillary sinus.
- 2. Smokers. 3. 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 |
|---|---|---|
| crestal sinus lifting using densah burs* Crestal flap was made. * 2 mm densah bur was used first as a pilot drill in clockwise direction and stopped 1 mm before sinus floor. Implant surgical motor setting was changed to reverse. * The next wider densah bur (3.00 mm) was used and advanced into the previous created osteotomy. When feeling the haptic feedback of the bur reaching the dense sinus floor, pressure was modulated with a pumping motion to advance past the sinus floor in 1 mm increments, up to 3 mm. * The sequential wider densah burs were used in densifing mode with copious irrigation with pumping motion to achieve additional width with maximum membrane lift of 3 mm to reach final desired width for implant placement. * The osteotomy was filled with a well hydrated, xenograft. The last densah bur was used in densifing mode with low speed 150-200 rpm with no irrigation. * The implant was placed into the osteotomy. | Procedure or surgery | crestal technique using densah burs |
| sinus lifting using lateral window techniqueAlso: lateral sinus lifting* Trapezoidal flap was made and full thickness mucoperiosteal flap was raised to visualize the lateral side of the maxilla. (Fig. 23) * Complete osteotomy of lateral window was made to gain access to the Schneiderian membrane using piezosurgery unit to minimize the probability of membrane perforation with round tip (SL3). * Sinus membrane elevators were used carefully to free up sinus membrane in all directions (mesially, distally and medially). * The membrane at the inferior aspect of the osteotomy was dissected from the floor of the maxillary sinus and elevated upward to create a space in the floor of the sinus for the bone graft material. * Drilling of the implant was done using surgical implant kit while using periosteal elevators to protect schniderian membrane. * Bone graft was packed under the membrane in all directions with the help of pluggers till reach the medial wall of the maxillary sinus. * Implant was placed and the lateral osteotomy was covered with collagen membrane | Procedure or surgery | lateral window technique |
Primary outcome
change from baseline in pain, as measured by Numerical Rating Scale (NRS)
Time frame: Baseline, 7 days
Pain was evaluated postoperatively at the day of surgery, 3rd and 7th day post-surgically Numerical Rating Scale (NRS). Numerical Rating Scale (NRS) is a simple, widely used tool, typically an 11-point scale (0-10), where patients rate their pain intensity, with 0 meaning "no pain" and 10 meaning "worst imaginable pain,".
change from baseline of edema
Time frame: baseline, 7 days
Edema was evaluated with the aid of tape measure (in centimeters). Three measurements were performed on the patient's operated site preoperatively, 3rd and 7th day after surgery. The evaluation of edema was done by subtracting the total value of the three measurements obtained postoperatively (at 3rd and 7th day) from the total value of the three measurements obtained at pre-operative baseline. The three measuring lines are: 1. Lateral corner of the eye-angle of the mandible. 2. Tragus-outer corner of the mouth. 3. Tragus pogonion.
change of implant stability, as measured by osstell
Time frame: baseline, 12 months
Stability was measured with osstell (ISQ) immediately after implant placement (T0) after 12 months (T12). ISQ is a scale that ranges from 1 to 100 and is used to assess implant stability. Scales greater than 70 ISQ indicate a high level of stability, scales between 60 and 69 means medium stability and scales >60 ISQ are considered as low stability.
change from baseline in Grafted sinus height (GSH)
Time frame: baseline, 12 months
CBCT was made preoperatively, immediately after sinus augmentation (T0) and 6 months after loading (T12) for evaluation of Grafted sinus height (GSH): the distance between the original sinus floor to the new sinus floor regarding crestal cortical line.
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 9 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Sinus Pneumatization
RecruitingPhase 2/3
Assessment of a New Enhanced Xenograft in Open Maxillary Sinus Augmentation
Maxillary Sinus Floor Augmentation, Maxillary Sinus Elevation
Recruiting
Graftless TSFE Via Self-tapping Implants
Edentulous Posterior Maxilla, Maxillary Sinus Pneumatization
RecruitingObservational study
Impact of Alveolar Ridge Preservation on the Potential Need for Sinus Floor Elevation: A 10-year Retrospective Radiographical Study
Alveolar Bone Loss, Sinus Floor Augmentation
Not yet recruitingObservational study
CBCT Study of Maxillary Sinus Dimensions and Greater Palatine Canal Pathway: A Retrospective Analysis
Pneumatization
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.
Wael Mohamed Ahmed, professor study director
department of oral and maxillofacial surgery, faculty of dentistry, mansoura 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 crestal sinus lifting using densah burs and sinus lifting using lateral window technique in people with Sinus Pneumatization, run by Delta University for Science and Technology 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 4 inclusion and 2 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 9 Jan 2026. 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?
change from baseline in pain, as measured by Numerical Rating Scale (NRS) (time frame: Baseline, 7 days). The study lists 4 primary outcomes in all. 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 9 Jan 2026.