Dental ImplantationNCT06323993
The Effect of Different Window-preparation Approaches on the Clinical Outcomes of Lateral Sinus Floor Elevation
An observational study of Dental Implantation and Cone-Beam Computed Tomography, run by The Dental Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial summary
This study retrospectively evaluated the effect of two different lateral window preparation techniques on peri-implant bone augmentation for patients who underwent lateral sinus floor elevation with simultaneous implant placement using two-dimensional and three-dimensional radiographic results, with special emphasis… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implantation, Cone-Beam Computed Tomography, Surgical Procedure, Unspecified
- What is being tested?
- Piezoelectric osteotomy
- Type of treatment
- Surgery or procedure
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to 15 Jun 2023
- Phase
- Observational
- 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
Study population: Consecutive subjects were selected among patients who have received LSFE with graft materials with simultaneous implant placement from November 2018 to June 2021 in the Department of Implantology at the Affiliated Hospital of Stomatology, Zhejiang University School of Medicine, China.
Who may be able to join
- age ≥18 years;
- one or more maxillary posterior teeth were missing, and the healing time was more than 3 months;
- complete basic information and detailed operation records;
- available CBCT images before surgery, immediately after surgery, and 6 months after surgery;
- RBH ≤6 mm shown by CBCT at T0 at the site of the missing tooth；
- no systematic diseases and no untreated periapical disease or periodontal disease before surgery.
Who cannot join
- (1) maxillary lesions have not been properly treated；
- present or past medication of bisphosphonates;
- pregnancy or lactation;
- present or past radiotherapy of head and neck cancer within 5 years;
- acute and chronic inflammation in the maxillary sinus;
- in need of additional vertical or horizontal bone augmentation besides LSFE with endo-sinus graft materials;
- heavy smoker (>20 cigarettes/day at the time of surgery).
Trial locations and contacts
1 site in 1 country.
China1 site
Stomatology Hospital, School of Stomatology, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
About this study
Official title: The Clinical Outcomes of Lateral Sinus Floor Elevation With Different Window Preparation Approaches: a Retrospective Study
This study retrospectively evaluated the effect of two different lateral window preparation techniques on peri-implant bone augmentation for patients who underwent lateral sinus floor elevation with simultaneous implant placement using two-dimensional and three-dimensional radiographic results, with special emphasis placed on the stability of the graft material after surgery.
- Conditions
- Dental Implantation, Cone-Beam Computed Tomography, Surgical Procedure, Unspecified, Maxillary Sinus Floor Augmentation
- Being tested
- Piezoelectric osteotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piezoelectric osteotomyProcedure or surgery
The piezoelectric technique, another window preparation procedure that does not use a round bur, was first introduced to LSFE in 2001 for its high accuracy of osteotomy and low rate of membrane perforation. Later studies demonstrated that the operation time, postoperative reactions, and perforation rate of this procedure are considered to be acceptable compared with rotary bur. Moreover, the piezoelectric technique allows for the lateral bone window to be cut and preserved relatively completely.
| Study group | Role | What they receive |
|---|---|---|
| Piezoelectric osteotomy | This group used piezoelectric osteotomy (exposure) to prepare the lateral window acceding maxillary sinus Receives: Procedure: Piezoelectric osteotomy | |
| Round Bur | This group used round bur (control) to prepare the lateral window acceding maxillary sinus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apical bone height
The distance (mm) from the implant apex to the most apical position of the graft material along the longitudinal axis of the implant
Measured: Immediately after surgery, and 6 months after surgery
Endo-sinus bone gain
The distance (mm) from the level of the sinus floor (middle of the buccal level and palatal level) to the level of the most apical position of the graft material along the longitudinal axis of the implant
Measured: Immediately after surgery, and 6 months after surgery
Palatal bone height
The vertical distance (mm) from the api- cal margin of the implant shoulder on the palatal side straight up to the position of the most apical position of the graft material
Measured: Immediately after surgery, and 6 months after surgery
Buccal bone height
The vertical distance (mm) from the api- cal margin of the implant shoulder on the buccal side straight up to the position of the most apical position of the graft material
Measured: Immediately after surgery, and 6 months after surgery
Augmentation volume
The volume of the endo-sinus reconstructed graft materials
Measured: Immediately after surgery, and 6 months after surgery
Secondary outcomes (4)
Perforation incidence
Sinus perforation was determined by direct visualization and the Valsalva maneuver during the surgery process.
Measured: During the surgery
Early implant loss
Early implant loss was defined as an implant show- ing clinical mobility prior to the placement of the abutment
Measured: 6 months after surgery
Lateral window length
the distance between the edges of lateral window caused by the lateral antrostomy
Measured: Immediately after surgery, and 6 months after surgery
Lateral bone length
the length of the bone window ob- tained by piezoelectric osteotomy
Measured: Immediately after surgery, and 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start1 Mar 2022
- Primary completion1 May 2022
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Dental Hospital of Zhejiang University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guoli Yang, The Dental Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06323993
- Sponsor's protocol ID
- 2021-115
- Status last verified
- Mar 2024
- First submitted
- 3 Sep 2023
- Last updated
- 21 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Outcomes of Lateral Sinus Floor Elevation With Different Window Preparation Approaches: a Retrospective Study
- ClinicalTrials.gov ID
- NCT06323993
- Acronym / sponsor ID
- 2021-115
- Conditions
- Dental Implantation, Cone-Beam Computed Tomography, Surgical Procedure, Unspecified, Maxillary Sinus Floor Augmentation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- The Dental Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 21 Mar 2024 (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.
This study retrospectively evaluated the effect of two different lateral window preparation techniques on peri-implant bone augmentation for patients who underwent lateral sinus floor elevation with simultaneous implant placement using two-dimensional and three-dimensional radiographic results, with special emphasis placed on the stability of the graft material after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Piezoelectric osteotomy | – | Procedure: Piezoelectric osteotomyThis group used piezoelectric osteotomy (exposure) to prepare the lateral window acceding maxillary sinus |
| Round Bur | – | –This group used round bur (control) to prepare the lateral window acceding maxillary sinus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive subjects were selected among patients who have received LSFE with graft materials with simultaneous implant placement from November 2018 to June 2021 in the Department of Implantology at the Affiliated Hospital of Stomatology, Zhejiang University School of Medicine, China.
Key inclusion criteria (6 listed)
- age ≥18 years;
- one or more maxillary posterior teeth were missing, and the healing time was more than 3 months;
- complete basic information and detailed operation records;
- available CBCT images before surgery, immediately after surgery, and 6 months after surgery;
- RBH ≤6 mm shown by CBCT at T0 at the site of the missing tooth；
Key exclusion criteria (7 listed)
- (1) maxillary lesions have not been properly treated；
- present or past medication of bisphosphonates;
- pregnancy or lactation;
- present or past radiotherapy of head and neck cancer within 5 years;
- acute and chronic inflammation in the maxillary sinus;
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 |
|---|---|---|
| Piezoelectric osteotomyThe piezoelectric technique, another window preparation procedure that does not use a round bur, was first introduced to LSFE in 2001 for its high accuracy of osteotomy and low rate of membrane perforation. Later studies demonstrated that the operation time, postoperative reactions, and perforation rate of this procedure are considered to be acceptable compared with rotary bur. Moreover, the piezoelectric technique allows for the lateral bone window to be cut and preserved relatively completely. | Procedure or surgery | Piezoelectric osteotomy |
Primary outcome
Apical bone height
Time frame: Immediately after surgery, and 6 months after surgery
The distance (mm) from the implant apex to the most apical position of the graft material along the longitudinal axis of the implant
Endo-sinus bone gain
Time frame: Immediately after surgery, and 6 months after surgery
The distance (mm) from the level of the sinus floor (middle of the buccal level and palatal level) to the level of the most apical position of the graft material along the longitudinal axis of the implant
Palatal bone height
Time frame: Immediately after surgery, and 6 months after surgery
The vertical distance (mm) from the api- cal margin of the implant shoulder on the palatal side straight up to the position of the most apical position of the graft material
Buccal bone height
Time frame: Immediately after surgery, and 6 months after surgery
The vertical distance (mm) from the api- cal margin of the implant shoulder on the buccal side straight up to the position of the most apical position of the graft material
Augmentation volume
Time frame: Immediately after surgery, and 6 months after surgery
The volume of the endo-sinus reconstructed graft materials
4 secondary outcomes
Perforation incidence
Time frame: During the surgery
Early implant loss
Time frame: 6 months after surgery
Lateral window length
Time frame: Immediately after surgery, and 6 months after surgery
Lateral bone length
Time frame: Immediately after surgery, and 6 months after 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 21 Mar 2024.
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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?
An observational study of Dental Implantation and Cone-Beam Computed Tomography, run by The Dental Hospital of Zhejiang University School of Medicine at 1 site in China.
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 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 21 Mar 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 China. 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?
Apical bone height (time frame: Immediately after surgery, and 6 months after surgery). The study lists 5 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 21 Mar 2024.