Maxillary Sinus Floor AugmentationNCT06055127
Osseodensifiction Versus Piezoelectric Internal Sinus Elevation Technique in Delayed Implant Placement
A study testing osseodensifiction internal sinus lift / sticky bone graft material and piezoelectric internal sinus lift / sticky bone graft material in people with Maxillary Sinus Floor Augmentation, run by Ain Shams University at 1 site in Egypt.
Trial summary
The present study is a parallel single-blinded randomized controlled clinical trial. The study will be conducted after being reviewed and approved by the Faculty of Dentistry, AinShams University Research Ethics Committee (FDASU-REC). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Maxillary Sinus Floor Augmentation
- What is being tested?
- osseodensifiction internal sinus lift / sticky bone graft material and piezoelectric internal sinus lift / sticky bone graft material
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Sep 2023to 31 May 2024
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient partially edentulous with maxillary posterior edentulous ridge after extraction of more than 4 months.
- Both sexes will be selected males and females.
- Adult patients aged between 18 and 40 years of age.
- Good general health (American Society of Anesthesiology Physical Status Ⅰ-Ⅱ).
- Initial residual alveolar ridge height ranging between 4 to 6 mm according to preoperative CBCT.
- No previous surgery or radiation treatment on the maxillary sinus.
Who cannot join
- 1. Smokers. 2. Pregnant or lactating females. 3. Psychiatric disorders. 4. Uncontrolled systemic disease. 5. Hematologic diseases and coagulation disorders. 6. Chemotherapy or radiotherapy of the head and neck area, and immunocompromised status.
- 7. Medical conditions affecting bone metabolism and ongoing treatment with bisphosphonates drugs or systemic steroids.
- 8. Presence of acute or chronic sinus pathoses or sinus membrane perforation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Osseodensifiction Versus Piezoelectric Internal Sinus Elevation (PISE) Technique in Delayed Implant Placement (A Randomized Controlled Clinical Trial)
The present study is a parallel single-blinded randomized controlled clinical trial.
The study will be conducted after being reviewed and approved by the Faculty of Dentistry, AinShams University Research Ethics Committee (FDASU-REC).
Read more
The study population will be randomly allocated into two groups of the same size:
Group 1: Osseodensifiction sinus lift will be performed using sticky bone as a graft material.
Group 2: Piezoelectric Internal Sinus Elevation (PISE) will be performed using sticky bone as a graft material.
The aim of the present study is to evaluate the effectiveness and clinical results of osseodensification in comparison to Piezoelectric Internal Sinus Elevation (PISE) Technique in Delayed Implant Placement.
- Conditions
- Maxillary Sinus Floor Augmentation
- Being tested
- osseodensifiction internal sinus lift / sticky bone graft material, piezoelectric internal sinus lift / sticky bone graft material
- Keywords
- internal sinus elevation, osseodensfication,, piezoelectric surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
osseodensifiction internal sinus lift / sticky bone graft materialProcedure or surgery
The osteotomy for the osseodensification internal sinus lift begins with a twist drill advanced at 800 rpm with saline irrigation to within 1-2 mm from the sinus floor. Next, a series of osteotomy drills are used in the same fashion at 800 rpm to widen the osteotomy. The final osteotomy drill is advanced with gentle pressure at 100 rpm counterclockwise without irrigation until a bouncing sensation occurs "haptic feedback" at this point infracture of the sinus has taken place. After infracture, injection of the graft material into the osteotomy site will occur. The final osteotomy drill is used to guide the graft apically. This process is repeated in an incremental fashion to lift the membrane. Once enough space has been created below the antral membrane, implant insertion will occur then suturing.
piezoelectric internal sinus lift / sticky bone graft materialProcedure or surgery
In the PISE technique, an ultrasonic piezoelectric device (acteon), to which a specialized tip is attached, is used to break the sinus floor. Developed for sinus lift by the crestal approach, the Intralift™ Kit makes it possible to undertake dental non invasive surgery in full safety.
The diamond-coated tips, of increasing diameters (from 1.35mm to 2.80mm), are designed to drill and gradually widen the access canal to the sinus membrane. The sterile spray cools the tips down to avoid any rise in temperature, which could lead to oral tissue damage.The membrane elevation is achieved using the TKW5 by means of microcavitation. Thanks to the ultrasonic frequency modulation, the risk of membrane damage is limited. Moreover, the cavitation effect enables excellent visibility of the operating field.
| Study group | Role | What they receive |
|---|---|---|
| osseodensifiction internal sinus lift / sticky bone graft material | Experimental | Osseodensifiction compacts bone and simultaneously autografts it into the osteotomy walls and apex instead of removing it. The use of a Densah® drill bit at high speed counterclockwise, without a cutting edge and with a steady irrigation causes the formation of a layer of strong dense bone along the walls of the base of the osteotomy preparation. Receives: Procedure: osseodensifiction internal sinus lift / sticky bone graft material |
| piezoelectric internal sinus lift / sticky bone graft material | Active comparator | The piezoelectric surgical sets comprise various inserts from osteotomies to diamond-cutting inserts. The hydropneumatics pressure of the saline solution irrigation is subjected to the piezoelectric cavitation pushing the Schneiderian membrane upwards resulting in its' detachment and floating Receives: Procedure: piezoelectric internal sinus lift / sticky bone graft material |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic assessment of change in the vertical bone height (bone gain)
Immediate postoperative CBCTs will be taken to all participants to assess bone gain .
Measured: per-operative and immediately post-operative
Radiographic assessment of bone density
Immediate postoperative CBCTs will be taken to all participants to assess bone density.
Measured: per-operative and immediately post-operative
Secondary outcomes (5)
implant primary stability (insertion torque )
implant insertion torque will be assessed using torque wrench .
Measured: during procedure
implant primary stability (ISQ)
implant stability quotient will be assessed using Osstell device
Measured: during procedure
patient post-operative pain assessment
obtained using a 100 mm visual analogue scale
Measured: 1 week post-operative
patient's satisfaction assessment
obtained by the aid of a health-related quality of life questionnaire
Measured: 1 week post-operative
operator's satisfaction assessment
obtained by the aid of a questionnaire assessing the operator's satisfaction
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start8 Sep 2023
- Primary completion30 Jan 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Maxillary Sinus Floor AugmentationStudies 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
- parallel single blind masking randomized controlled clinical trail
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Samir, Ain Shams University
- Investigators
- Mohammed Samir, BDs, Principal investigator, AinShams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06055127
- Sponsor's protocol ID
- FDASU_Rec IM 122215
- Status last verified
- Jul 2024
- First submitted
- 16 Sep 2023
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 30427961Pjetursson BE, Lang NP. Sinus floor elevation utilizing the transalveolar approach. Periodontol 2000. 2014 Oct;66(1):59-71. doi: 10.1111/prd.12043.
PubMed 25123761Torrella F, Pitarch J, Cabanes G, Anitua E. Ultrasonic ostectomy for the surgical approach of the maxillary sinus: a technical note. Int J Oral Maxillofac Implants. 1998 Sep-Oct;13(5):697-700.
PubMed 9796155Li J, Lee K, Chen H, Ou G. Piezoelectric surgery in maxillary sinus floor elevation with hydraulic pressure for xenograft and simultaneous implant placement. J Prosthet Dent. 2013 Nov;110(5):344-8. doi: 10.1016/j.prosdent.2013.04.002. Epub 2013 Sep 29.
PubMed 24084145Mourao CF, Valiense H, Melo ER, Mourao NB, Maia MD. Obtention of injectable platelets rich-fibrin (i-PRF) and its polymerization with bone graft: technical note. Rev Col Bras Cir. 2015 Nov-Dec;42(6):421-3. doi: 10.1590/0100-69912015006013. English, Portuguese.
PubMed 26814997Samir M, Bissar MW, Abuel-Ela HA. Osseodensification versus piezoelectric internal sinus elevation (PISE) technique in delayed implant placement (a randomized controlled clinical trial). BMC Oral Health. 2024 Oct 28;24(1):1306. doi: 10.1186/s12903-024-04964-6.
PubMed 39468538
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osseodensifiction Versus Piezoelectric Internal Sinus Elevation (PISE) Technique in Delayed Implant Placement (A Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT06055127
- Acronym / sponsor ID
- FDASU_Rec IM 122215
- Conditions
- Maxillary Sinus Floor Augmentation
- Keywords
- internal sinus elevation, osseodensfication,, piezoelectric surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 8 Sep 2023 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 26 Sep 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 present study is a parallel single-blinded randomized controlled clinical trial.
The study will be conducted after being reviewed and approved by the Faculty of Dentistry, AinShams University Research Ethics Committee (FDASU-REC).
The study population will be randomly allocated into two groups of the same size:
Group 1: Osseodensifiction sinus lift will be performed using sticky bone as a graft material.
Group 2: Piezoelectric Internal Sinus Elevation (PISE) will be performed using sticky bone as a graft material.
The aim of the present study is to evaluate the effectiveness and clinical results of osseodensification in comparison to Piezoelectric Internal Sinus Elevation (PISE) Technique in Delayed Implant Placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- parallel single blind masking randomized controlled clinical trail
| Arm | Type | Receives |
|---|---|---|
| osseodensifiction internal sinus lift / sticky bone graft material | Experimental | Procedure: osseodensifiction internal sinus lift / sticky bone graft materialOsseodensifiction compacts bone and simultaneously autografts it into the osteotomy walls and apex instead of removing it. The use of a Densah® drill bit at high speed counterclockwise, without a cutting edge and with a steady irrigation causes the formation of a layer of strong dense bone along the walls of the base of the osteotomy preparation. |
| piezoelectric internal sinus lift / sticky bone graft material | Active comparator | Procedure: piezoelectric internal sinus lift / sticky bone graft materialThe piezoelectric surgical sets comprise various inserts from osteotomies to diamond-cutting inserts. The hydropneumatics pressure of the saline solution irrigation is subjected to the piezoelectric cavitation pushing the Schneiderian membrane upwards resulting in its' detachment and floating |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patient partially edentulous with maxillary posterior edentulous ridge after extraction of more than 4 months.
- Both sexes will be selected males and females.
- Adult patients aged between 18 and 40 years of age.
- Good general health (American Society of Anesthesiology Physical Status Ⅰ-Ⅱ).
- Initial residual alveolar ridge height ranging between 4 to 6 mm according to preoperative CBCT.
Key exclusion criteria (3 listed)
- 1. Smokers. 2. Pregnant or lactating females. 3. Psychiatric disorders. 4. Uncontrolled systemic disease. 5. Hematologic diseases and coagulation disorders. 6. Chemotherapy or radiotherapy of the head and neck area, and immunocompromised status.
- 7. Medical conditions affecting bone metabolism and ongoing treatment with bisphosphonates drugs or systemic steroids.
- 8. Presence of acute or chronic sinus pathoses or sinus membrane perforation.
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 |
|---|---|---|
| osseodensifiction internal sinus lift / sticky bone graft materialThe osteotomy for the osseodensification internal sinus lift begins with a twist drill advanced at 800 rpm with saline irrigation to within 1-2 mm from the sinus floor. Next, a series of osteotomy drills are used in the same fashion at 800 rpm to widen the osteotomy. The final osteotomy drill is advanced with gentle pressure at 100 rpm counterclockwise without irrigation until a bouncing sensation occurs "haptic feedback" at this point infracture of the sinus has taken place. After infracture, injection of the graft material into the osteotomy site will occur. The final osteotomy drill is used to guide the graft apically. This process is repeated in an incremental fashion to lift the membrane. Once enough space has been created below the antral membrane, implant insertion will occur then suturing. | Procedure or surgery | osseodensifiction internal sinus lift / sticky bone graft material |
| piezoelectric internal sinus lift / sticky bone graft materialIn the PISE technique, an ultrasonic piezoelectric device (acteon), to which a specialized tip is attached, is used to break the sinus floor. Developed for sinus lift by the crestal approach, the Intralift™ Kit makes it possible to undertake dental non invasive surgery in full safety. The diamond-coated tips, of increasing diameters (from 1.35mm to 2.80mm), are designed to drill and gradually widen the access canal to the sinus membrane. The sterile spray cools the tips down to avoid any rise in temperature, which could lead to oral tissue damage.The membrane elevation is achieved using the TKW5 by means of microcavitation. Thanks to the ultrasonic frequency modulation, the risk of membrane damage is limited. Moreover, the cavitation effect enables excellent visibility of the operating field. | Procedure or surgery | piezoelectric internal sinus lift / sticky bone graft material |
Primary outcome
Radiographic assessment of change in the vertical bone height (bone gain)
Time frame: per-operative and immediately post-operative
Immediate postoperative CBCTs will be taken to all participants to assess bone gain .
Radiographic assessment of bone density
Time frame: per-operative and immediately post-operative
Immediate postoperative CBCTs will be taken to all participants to assess bone density.
5 secondary outcomes
implant primary stability (insertion torque )
Time frame: during procedure
implant primary stability (ISQ)
Time frame: during procedure
patient post-operative pain assessment
Time frame: 1 week post-operative
patient's satisfaction assessment
Time frame: 1 week post-operative
operator's satisfaction assessment
Time frame: 1 year
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 31 Jul 2024.
- 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 25123761Pjetursson BE, Lang NP. Sinus floor elevation utilizing the transalveolar approach. Periodontol 2000. 2014 Oct;66(1):59-71. doi: 10.1111/prd.12043.
- Background: PubMed 9796155Torrella F, Pitarch J, Cabanes G, Anitua E. Ultrasonic ostectomy for the surgical approach of the maxillary sinus: a technical note. Int J Oral Maxillofac Implants. 1998 Sep-Oct;13(5):697-700.
- Background: PubMed 24084145Li J, Lee K, Chen H, Ou G. Piezoelectric surgery in maxillary sinus floor elevation with hydraulic pressure for xenograft and simultaneous implant placement. J Prosthet Dent. 2013 Nov;110(5):344-8. doi: 10.1016/j.prosdent.2013.04.002. Epub 2013 Sep 29.
- Background: PubMed 26814997Mourao CF, Valiense H, Melo ER, Mourao NB, Maia MD. Obtention of injectable platelets rich-fibrin (i-PRF) and its polymerization with bone graft: technical note. Rev Col Bras Cir. 2015 Nov-Dec;42(6):421-3. doi: 10.1590/0100-69912015006013. English, Portuguese.
- Derived from this study: PubMed 39468538Samir M, Bissar MW, Abuel-Ela HA. Osseodensification versus piezoelectric internal sinus elevation (PISE) technique in delayed implant placement (a randomized controlled clinical trial). BMC Oral Health. 2024 Oct 28;24(1):1306. doi: 10.1186/s12903-024-04964-6.
- 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.
Mohammed Samir, BDs principal investigator
AinShams 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 osseodensifiction internal sinus lift / sticky bone graft material and piezoelectric internal sinus lift / sticky bone graft material in people with Maxillary Sinus Floor Augmentation, run by Ain Shams 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 6 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 31 Jul 2024. 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?
Radiographic assessment of change in the vertical bone height (bone gain) (time frame: per-operative and immediately post-operative). The study lists 2 primary outcomes in all. 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 NCT06055127, which also lists 6 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 31 Jul 2024.