Dental ImplantNCT06126536
Transcrestal Sinus Lift Using Osseodensification Versus Lateral Window Technique
A study testing Crestal Maxillary Sinus Floor Elevation using Osseodensification and Lateral Maxillary Sinus Floor Elevation in people with Dental Implant and Sinus Lifting, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the transcrestal sinus lift using Osseodensification versus lateral window technique with simultaneous implant placement. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implant, Sinus Lifting
- What is being tested?
- Crestal Maxillary Sinus Floor Elevation using Osseodensification and Lateral Maxillary Sinus Floor Elevation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Dec 2019to 13 Mar 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient with residual bone height from 4-6 mm and bone quality is D3 or D4.
- Patients had to require implant treatment in the posterior maxilla.
- All patients will sign a consent form before the study.
Who cannot join
- 1- Sinus pathology that precludes routine sinus augmentation.
- All contraindications of dental implants.11,12
- Heavy smokers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcrestal Sinus Lift Using Osseodensification Versus Lateral Window Technique With Simultaneous Implant Placement
The aim of this study is to evaluate the transcrestal sinus lift using Osseodensification versus lateral window technique with simultaneous implant placement.
Read the detailed description
In Group 1, crestal maxillary sinus floor elevation will be done using Osseodensification. An incision will be made near the palate, and a conservative flap will be elevated. Osseodensification burs will be used to create an osteotomy and elevate the sinus membrane gradually. The osteotomy will be filled with bone graft, and the implant will be inserted.
In Group 2, lateral maxillary sinus floor elevation will be performed by creating a bony window in the lateral wall of the sinus. The sinus floor will be carefully elevated using sinus elevation curettes. If there's a membrane perforation, a collagen membrane will be applied. Bone substitute material will be packed into the sinus, and a resorbable membrane will be placed over the window before suturing.
Both groups will use Nanobone as the graft material.
- Conditions
- Dental Implant, Sinus Lifting
- Being tested
- Crestal Maxillary Sinus Floor Elevation using Osseodensification, Lateral Maxillary Sinus Floor Elevation
- Keywords
- Osseodensification, Densah Burs, Internal Sinus lifting, External Sinus lifting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crestal Maxillary Sinus Floor Elevation using OsseodensificationProcedure or surgery
Patients will be prepared for surgery with local anesthesia and thorough oral cavity disinfection. A full thickness crestal incision will be made slightly towards the palate to enhance the possibility of achieving primary wound closure. A conservative flap will be raised, extending slightly beyond the alveolar crest, to minimize flap-related issues. After preparing the osteotomy site using Densah burs and elevating the sinus to the desired height, the implant will be inserted into the osteotomy site.
Lateral Maxillary Sinus Floor ElevationProcedure or surgery
A crestal incision with an anterior vertical releasing incision exposes the sinus's lateral wall. A mucoperiosteal flap is carefully reflected, revealing the sinus. A bony window is created using a Piezoelectric device, and after elevation, the sinus floor is carefully lifted with various curettes. Implant osteotomies follow standard placement protocol, with precautions against sinus membrane perforation. Nanobone is used as graft material, mixed with saline and gently packed into the sinus. A resorbable membrane is placed on the window's outer surface, secured with circumferential resorbable sutures, and the flap is sutured for closure.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Crestal Maxillary Sinus Floor Elevation using Osseodensification: | Experimental | A crestal incision will be made towards the palate for better wound closure. A conservative flap will be raised, extending beyond the alveolar crest to minimize complications. In cases with 4-6mm ridge height and a need for 3mm vertical depth, a narrow densifying bur will be used, followed by wider burs to elevate the sinus membrane. The Densah® Bur will compact graft material to lift the membrane without penetrating the sinus floor. The osteotomy will be filled with bone graft substitute, and the final bur will apically propel the graft for vertical augmentation. Implant placement follows confirmation via radiography. Receives: Procedure: Crestal Maxillary Sinus Floor Elevation using Osseodensification |
| Group 2: Lateral Maxillary Sinus Floor Elevation | Experimental | In the Lateral technique, a crestal incision and mucoperiosteal flap will expose the sinus's lateral wall. A bony window is created, and when removable, sinus elevation curettes are used to elevate the sinus floor cautiously. Membrane perforations are covered with a resorbable collagen membrane if needed. Implant osteotomies follow standard protocol.
Graft material mixed with saline is gently packed into the sinus to achieve the desired bone height. A resorbable membrane is placed on the window's outer surface, and the flap is sutured for primary closure. Receives: Procedure: Lateral Maxillary Sinus Floor Elevation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone height gain
In Millimeter(mm)
Measured: Immediate post-operative, 6 Months post-operative
Secondary outcomes (3)
Ridge height
In Millimeter(mm)
Measured: Immediate post-operative, 6 Months post-operative
Implant stability
In implant stability quotient (ISQ)
Measured: Immediate post-operative, 6 Months post-operative
Bone Density
In Hounsfield units (HU)
Measured: Immediate post-operative, 6 Months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start7 Dec 2019
- Primary completion13 Mar 2022
- Study completion13 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Dental ImplantStudies 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, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Elsaid, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06126536
- Sponsor's protocol ID
- AUAREC20190100-04
- Status last verified
- Nov 2023
- First submitted
- 7 Nov 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Moraschini V, Uzeda MG, Sartoretto SC, Calasans-Maia MD. Maxillary sinus floor elevation with simultaneous implant placement without grafting materials: a systematic review and meta-analysis. Int J Oral Maxillofac Surg. 2017 May;46(5):636-647. doi: 10.1016/j.ijom.2017.01.021. Epub 2017 Feb 21.
PubMed 28254402Pjetursson BE, Tan WC, Zwahlen M, Lang NP. A systematic review of the success of sinus floor elevation and survival of implants inserted in combination with sinus floor elevation. J Clin Periodontol. 2008 Sep;35(8 Suppl):216-40. doi: 10.1111/j.1600-051X.2008.01272.x.
PubMed 18724852Jensen SS, Terheyden H. Bone augmentation procedures in localized defects in the alveolar ridge: clinical results with different bone grafts and bone-substitute materials. Int J Oral Maxillofac Implants. 2009;24 Suppl:218-36.
PubMed 19885447Chiapasco M, Casentini P, Zaniboni M. Bone augmentation procedures in implant dentistry. Int J Oral Maxillofac Implants. 2009;24 Suppl:237-59.
PubMed 19885448Summers RB. Sinus floor elevation with osteotomes. J Esthet Dent. 1998;10(3):164-71. doi: 10.1111/j.1708-8240.1998.tb00352.x.
PubMed 9759033Suk-Arj P, Wongchuensoontorn C, Taebunpakul P. Evaluation of bone formation following the osteotome sinus floor elevation technique without grafting using cone beam computed tomography: a preliminary study. Int J Implant Dent. 2019 Aug 1;5(1):27. doi: 10.1186/s40729-019-0181-7.
PubMed 31367919Kfir E, Goldstein M, Yerushalmi I, Rafaelov R, Mazor Z, Kfir V, Kaluski E. Minimally invasive antral membrane balloon elevation - results of a multicenter registry. Clin Implant Dent Relat Res. 2009 Oct;11 Suppl 1:e83-91. doi: 10.1111/j.1708-8208.2009.00213.x. Epub 2009 Aug 3.
PubMed 19681937Toffler M, Rosen P. Complications with transcrestal sinus floor elevation: Etiology, prevention, and treatment. In: Froum S (ed). Dental Implant Complications: Etiology, Prevention, and Treatment Hoboken, New Jersey: Wiley, 2015.
Huwais S, Mazor Z, Ioannou AL, Gluckman H, Neiva R. A Multicenter Retrospective Clinical Study with Up-to-5-Year Follow-up Utilizing a Method that Enhances Bone Density and Allows for Transcrestal Sinus Augmentation Through Compaction Grafting. Int J Oral Maxillofac Implants. 2018 Nov/Dec;33(6):1305-1311. doi: 10.11607/jomi.6770.
PubMed 30427961Huwais S, Meyer EG. A Novel Osseous Densification Approach in Implant Osteotomy Preparation to Increase Biomechanical Primary Stability, Bone Mineral Density, and Bone-to-Implant Contact. Int J Oral Maxillofac Implants. 2017 Jan/Feb;32(1):27-36. doi: 10.11607/jomi.4817. Epub 2016 Oct 14.
PubMed 27741329
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcrestal Sinus Lift Using Osseodensification Versus Lateral Window Technique With Simultaneous Implant Placement
- ClinicalTrials.gov ID
- NCT06126536
- Acronym / sponsor ID
- AUAREC20190100-04
- Conditions
- Dental Implant, Sinus Lifting
- Keywords
- Osseodensification, Densah Burs, Internal Sinus lifting, External Sinus lifting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 7 Dec 2019 (actual)
- Primary completion
- 13 Mar 2022 (actual)
- Study completion
- 13 Mar 2022 (actual)
- First posted
- 13 Nov 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.
The aim of this study is to evaluate the transcrestal sinus lift using Osseodensification versus lateral window technique with simultaneous implant placement.
Detailed description
In Group 1, crestal maxillary sinus floor elevation will be done using Osseodensification. An incision will be made near the palate, and a conservative flap will be elevated. Osseodensification burs will be used to create an osteotomy and elevate the sinus membrane gradually. The osteotomy will be filled with bone graft, and the implant will be inserted.
In Group 2, lateral maxillary sinus floor elevation will be performed by creating a bony window in the lateral wall of the sinus. The sinus floor will be carefully elevated using sinus elevation curettes. If there's a membrane perforation, a collagen membrane will be applied. Bone substitute material will be packed into the sinus, and a resorbable membrane will be placed over the window before suturing.
Both groups will use Nanobone as the graft material.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Crestal Maxillary Sinus Floor Elevation using Osseodensification: | Experimental | Procedure: Crestal Maxillary Sinus Floor Elevation using OsseodensificationA crestal incision will be made towards the palate for better wound closure. A conservative flap will be raised, extending beyond the alveolar crest to minimize complications. In cases with 4-6mm ridge height and a need for 3mm vertical depth, a narrow densifying bur will be used, followed by wider burs to elevate the sinus membrane. The Densah® Bur will compact graft material to lift the membrane without penetrating the sinus floor. The osteotomy will be filled with bone graft substitute, and the final bur will apically propel the graft for vertical augmentation. Implant placement follows confirmation via radiography. |
| Group 2: Lateral Maxillary Sinus Floor Elevation | Experimental | Procedure: Lateral Maxillary Sinus Floor ElevationIn the Lateral technique, a crestal incision and mucoperiosteal flap will expose the sinus's lateral wall. A bony window is created, and when removable, sinus elevation curettes are used to elevate the sinus floor cautiously. Membrane perforations are covered with a resorbable collagen membrane if needed. Implant osteotomies follow standard protocol. Graft material mixed with saline is gently packed into the sinus to achieve the desired bone height. A resorbable membrane is placed on the window's outer surface, and the flap is sutured for primary closure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with residual bone height from 4-6 mm and bone quality is D3 or D4.
- Patients had to require implant treatment in the posterior maxilla.
- All patients will sign a consent form before the study.
Key exclusion criteria (3 listed)
- 1- Sinus pathology that precludes routine sinus augmentation.
- All contraindications of dental implants.11,12
- Heavy smokers.
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 Maxillary Sinus Floor Elevation using OsseodensificationPatients will be prepared for surgery with local anesthesia and thorough oral cavity disinfection. A full thickness crestal incision will be made slightly towards the palate to enhance the possibility of achieving primary wound closure. A conservative flap will be raised, extending slightly beyond the alveolar crest, to minimize flap-related issues. After preparing the osteotomy site using Densah burs and elevating the sinus to the desired height, the implant will be inserted into the osteotomy site. | Procedure or surgery | Group 1: Crestal Maxillary Sinus Floor Elevation using Osseodensification: |
| Lateral Maxillary Sinus Floor ElevationA crestal incision with an anterior vertical releasing incision exposes the sinus's lateral wall. A mucoperiosteal flap is carefully reflected, revealing the sinus. A bony window is created using a Piezoelectric device, and after elevation, the sinus floor is carefully lifted with various curettes. Implant osteotomies follow standard placement protocol, with precautions against sinus membrane perforation. Nanobone is used as graft material, mixed with saline and gently packed into the sinus. A resorbable membrane is placed on the window's outer surface, secured with circumferential resorbable sutures, and the flap is sutured for closure. | Procedure or surgery | Group 2: Lateral Maxillary Sinus Floor Elevation |
Primary outcome
Bone height gain
Time frame: Immediate post-operative, 6 Months post-operative
In Millimeter(mm)
3 secondary outcomes
Ridge height
Time frame: Immediate post-operative, 6 Months post-operative
Implant stability
Time frame: Immediate post-operative, 6 Months post-operative
Bone Density
Time frame: Immediate post-operative, 6 Months post-operative
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 13 Nov 2023.
- Background: PubMed 28254402Moraschini V, Uzeda MG, Sartoretto SC, Calasans-Maia MD. Maxillary sinus floor elevation with simultaneous implant placement without grafting materials: a systematic review and meta-analysis. Int J Oral Maxillofac Surg. 2017 May;46(5):636-647. doi: 10.1016/j.ijom.2017.01.021. Epub 2017 Feb 21.
- Background: PubMed 18724852Pjetursson BE, Tan WC, Zwahlen M, Lang NP. A systematic review of the success of sinus floor elevation and survival of implants inserted in combination with sinus floor elevation. J Clin Periodontol. 2008 Sep;35(8 Suppl):216-40. doi: 10.1111/j.1600-051X.2008.01272.x.
- Background: PubMed 19885447Jensen SS, Terheyden H. Bone augmentation procedures in localized defects in the alveolar ridge: clinical results with different bone grafts and bone-substitute materials. Int J Oral Maxillofac Implants. 2009;24 Suppl:218-36.
- Background: PubMed 19885448Chiapasco M, Casentini P, Zaniboni M. Bone augmentation procedures in implant dentistry. Int J Oral Maxillofac Implants. 2009;24 Suppl:237-59.
- Background: PubMed 9759033Summers RB. Sinus floor elevation with osteotomes. J Esthet Dent. 1998;10(3):164-71. doi: 10.1111/j.1708-8240.1998.tb00352.x.
- Background: PubMed 31367919Suk-Arj P, Wongchuensoontorn C, Taebunpakul P. Evaluation of bone formation following the osteotome sinus floor elevation technique without grafting using cone beam computed tomography: a preliminary study. Int J Implant Dent. 2019 Aug 1;5(1):27. doi: 10.1186/s40729-019-0181-7.
- Background: PubMed 19681937Kfir E, Goldstein M, Yerushalmi I, Rafaelov R, Mazor Z, Kfir V, Kaluski E. Minimally invasive antral membrane balloon elevation - results of a multicenter registry. Clin Implant Dent Relat Res. 2009 Oct;11 Suppl 1:e83-91. doi: 10.1111/j.1708-8208.2009.00213.x. Epub 2009 Aug 3.
- BackgroundToffler M, Rosen P. Complications with transcrestal sinus floor elevation: Etiology, prevention, and treatment. In: Froum S (ed). Dental Implant Complications: Etiology, Prevention, and Treatment Hoboken, New Jersey: Wiley, 2015.
- Background: PubMed 30427961Huwais S, Mazor Z, Ioannou AL, Gluckman H, Neiva R. A Multicenter Retrospective Clinical Study with Up-to-5-Year Follow-up Utilizing a Method that Enhances Bone Density and Allows for Transcrestal Sinus Augmentation Through Compaction Grafting. Int J Oral Maxillofac Implants. 2018 Nov/Dec;33(6):1305-1311. doi: 10.11607/jomi.6770.
- Background: PubMed 27741329Huwais S, Meyer EG. A Novel Osseous Densification Approach in Implant Osteotomy Preparation to Increase Biomechanical Primary Stability, Bone Mineral Density, and Bone-to-Implant Contact. Int J Oral Maxillofac Implants. 2017 Jan/Feb;32(1):27-36. doi: 10.11607/jomi.4817. Epub 2016 Oct 14.
- Individual participant dataSharing planned: Yes
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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 Maxillary Sinus Floor Elevation using Osseodensification and Lateral Maxillary Sinus Floor Elevation in people with Dental Implant and Sinus Lifting, run by Al-Azhar 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 3 inclusion and 3 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 13 Nov 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?
Bone height gain (time frame: Immediate post-operative, 6 Months post-operative). 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 NCT06126536, which also lists 10 linked publications.
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 13 Nov 2023.