Intraoperative OutcomesNCT04499625
Lateral Window Versus Intralift™ Sinus Floor Elevation
A study testing Sinus floor elevation and Sinus floor elevation using an ultrasonic device in people with Intraoperative Outcomes and Postoperative Outcomes, run by University of Liege.
Trial summary
Several approaches have been used in order to regenerate bone in the upper jaw in case of insufficient alveolar bone height for implant placement. However, new emerging techniques need to be assessed and compared to conventional methods in order to define their potential indications. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intraoperative Outcomes, Postoperative Outcomes
- What is being tested?
- Sinus floor elevation and Sinus floor elevation using an ultrasonic device
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- May 2013to May 2018
- 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
- edentulism in the posterior maxilla (unitary or plural)
- need of a sinus floor augmentation procedure before implant placement
Who cannot join
- any uncontrolled systemic disease
- ongoing chemo- or radiotherapy
- history of maxillary sinus diseases or acute sinus-related issues
About this study
Official title: Intraoperative and Postoperative Outcomes of Sinus Floor Elevation Using Lateral Window Technique Versus Hydrodynamic Transalveolar Approach: A Randomized Controlled Trial
Several approaches have been used in order to regenerate bone in the upper jaw in case of insufficient alveolar bone height for implant placement. However, new emerging techniques need to be assessed and compared to conventional methods in order to define their potential indications.
The purpose of the present randomized controlled clinical trial was to compare the clinical outcomes of two sinus floor elevation techniques: conventional lateral window technique versus a novel transalveolar approach using hydrodynamic ultrasonic device.
- Conditions
- Intraoperative Outcomes, Postoperative Outcomes
- Being tested
- Sinus floor elevation, Sinus floor elevation using an ultrasonic device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sinus floor elevationProcedure or surgery
Sinus floor elevation using an ultrasonic deviceDevice
| Study group | Role | What they receive |
|---|---|---|
| Control - Lateral window | Other | Standard surgical technique to access maxillary sinus for sinus floor augmentation procedure. Receives: Procedure: Sinus floor elevation |
| Test - Hydrodynamic transalveolar approach | Experimental | Novel transalveolar approach (using an ultrasonic device) to access maxillary sinus for sinus floor augmentation procedure. Receives: Device: Sinus floor elevation using an ultrasonic device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sinus membrane perforation
Presence/absence of sinus membrane perforation during the surgery
Measured: During the surgery (from beginning to end)
Surgical procedure duration
The time measurement started from the administration of local anesthesia and ended when the placement of final suture was completed. The time was measured using a stopwatch.
Measured: From beginning of surgery until the end of surgery
Edema
Presence/absence of edema postoperatively
Measured: From the end of surgery up to 1 week postoperatively
Hematoma
Presence/absence of hematoma postoperatively
Measured: From the end of surgery up to 1 week postoperatively
Postsurgical bleeding
Presence/absence of bleeding postoperatively
Measured: From the end of surgery up to 1 week postoperatively
Nasal discharge
Presence/absence of nasal discharge postoperatively
Measured: From the end of surgery up to 1 week postoperatively
NSAID consumption
Quantification of NSAID consumption per day up to 1 week postoperatively (tablets/per day)
Measured: From the end of surgery up to 1 week postoperatively
Patient related outcome measures (PROMs)
PROMs were assessed with a questionnaire using a visual analogue scale (VAS), which was given to all participants in order to assess their perception before, during, and after the intervention. A graduated scale from 0 to 10 was used, with a lower score presenting a better outcome.
Measured: From right before the surgery up to 1 week postoperatively
Secondary outcomes (2)
Radiographic outcomes
Radiographic (CBCT) qualitative assessment of the gained volume (change in volume from baseline to 1 year postoperatively).
Measured: From the baseline (surgery procedure) up to 1 year post-surgery
Implant survival rates
Implant survival rates assessment at 1 year postoperatively.
Measured: From the baseline (surgery procedure) up to 1 year post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study startMay 2013
- Primary completionMay 2018
- Study completionMay 2018
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 Intraoperative OutcomesStudies 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, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. France LAMBERT, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04499625
- Sponsor's protocol ID
- B707201316423
- Status last verified
- Jul 2020
- First submitted
- 14 Jul 2020
- Last updated
- 5 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bacevic M, Compeyron Y, Lecloux G, Rompen E, Lambert F. Intraoperative and postoperative outcomes of sinus floor elevation using the lateral window technique versus the hydrodynamic transalveolar approach: a preliminary randomized controlled trial. Clin Oral Investig. 2021 Sep;25(9):5391-5401. doi: 10.1007/s00784-021-03847-2. Epub 2021 Mar 10.
PubMed 33694027
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative and Postoperative Outcomes of Sinus Floor Elevation Using Lateral Window Technique Versus Hydrodynamic Transalveolar Approach: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04499625
- Acronym / sponsor ID
- B707201316423
- Conditions
- Intraoperative Outcomes, Postoperative Outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- May 2013 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 5 Aug 2020 (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.
Several approaches have been used in order to regenerate bone in the upper jaw in case of insufficient alveolar bone height for implant placement. However, new emerging techniques need to be assessed and compared to conventional methods in order to define their potential indications.
The purpose of the present randomized controlled clinical trial was to compare the clinical outcomes of two sinus floor elevation techniques: conventional lateral window technique versus a novel transalveolar approach using hydrodynamic ultrasonic device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control - Lateral window | Other | Procedure: Sinus floor elevationStandard surgical technique to access maxillary sinus for sinus floor augmentation procedure. |
| Test - Hydrodynamic transalveolar approach | Experimental | Device: Sinus floor elevation using an ultrasonic deviceNovel transalveolar approach (using an ultrasonic device) to access maxillary sinus for sinus floor augmentation procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- edentulism in the posterior maxilla (unitary or plural)
- need of a sinus floor augmentation procedure before implant placement
Key exclusion criteria (3 listed)
- any uncontrolled systemic disease
- ongoing chemo- or radiotherapy
- history of maxillary sinus diseases or acute sinus-related issues
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 |
|---|---|---|
| Sinus floor elevation | Procedure or surgery | Control - Lateral window |
| Sinus floor elevation using an ultrasonic device | Device | Test - Hydrodynamic transalveolar approach |
Primary outcome
Sinus membrane perforation
Time frame: During the surgery (from beginning to end)
Presence/absence of sinus membrane perforation during the surgery
Surgical procedure duration
Time frame: From beginning of surgery until the end of surgery
The time measurement started from the administration of local anesthesia and ended when the placement of final suture was completed. The time was measured using a stopwatch.
Edema
Time frame: From the end of surgery up to 1 week postoperatively
Presence/absence of edema postoperatively
Hematoma
Time frame: From the end of surgery up to 1 week postoperatively
Presence/absence of hematoma postoperatively
Postsurgical bleeding
Time frame: From the end of surgery up to 1 week postoperatively
Presence/absence of bleeding postoperatively
Nasal discharge
Time frame: From the end of surgery up to 1 week postoperatively
Presence/absence of nasal discharge postoperatively
NSAID consumption
Time frame: From the end of surgery up to 1 week postoperatively
Quantification of NSAID consumption per day up to 1 week postoperatively (tablets/per day)
Patient related outcome measures (PROMs)
Time frame: From right before the surgery up to 1 week postoperatively
PROMs were assessed with a questionnaire using a visual analogue scale (VAS), which was given to all participants in order to assess their perception before, during, and after the intervention. A graduated scale from 0 to 10 was used, with a lower score presenting a better outcome.
2 secondary outcomes
Radiographic outcomes
Time frame: From the baseline (surgery procedure) up to 1 year post-surgery
Implant survival rates
Time frame: From the baseline (surgery procedure) up to 1 year post-surgery
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 5 Aug 2020.
- Derived from this study: PubMed 33694027Bacevic M, Compeyron Y, Lecloux G, Rompen E, Lambert F. Intraoperative and postoperative outcomes of sinus floor elevation using the lateral window technique versus the hydrodynamic transalveolar approach: a preliminary randomized controlled trial. Clin Oral Investig. 2021 Sep;25(9):5391-5401. doi: 10.1007/s00784-021-03847-2. Epub 2021 Mar 10.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Sinus floor elevation and Sinus floor elevation using an ultrasonic device in people with Intraoperative Outcomes and Postoperative Outcomes, run by University of Liege.
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 2 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 5 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Sinus membrane perforation (time frame: During the surgery (from beginning to end)). The study lists 8 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 NCT04499625, 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 5 Aug 2020.