Clinical trial NCT06323993: The Effect of Different Window-preparation Approaches on the Clinical Outcomes of Lateral Sinus Floor Elevation
Official title: The Clinical Outcomes of Lateral Sinus Floor Elevation With Different Window Preparation Approaches: a Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Implantation
Cone-Beam Computed Tomography
Surgical Procedure, Unspecified
Maxillary Sinus Floor Augmentation
Lead sponsor: The Dental Hospital of Zhejiang University School of Medicine
Sponsor class: OTHER
First posted: 2024-03-21
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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 placed on the stability of the graft material after surgery.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* (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).

Primary outcomes:
measure: Apical bone height
timeFrame: Immediately after surgery, and 6 months after surgery
measure: Endo-sinus bone gain
timeFrame: Immediately after surgery, and 6 months after surgery
measure: Palatal bone height
timeFrame: Immediately after surgery, and 6 months after surgery
measure: Buccal bone height
timeFrame: Immediately after surgery, and 6 months after surgery
measure: Augmentation volume
timeFrame: Immediately after surgery, and 6 months after surgery
Secondary outcomes:
measure: Perforation incidence
timeFrame: During the surgery
measure: Early implant loss
timeFrame: 6 months after surgery
measure: Lateral window length
timeFrame: Immediately after surgery, and 6 months after surgery
measure: Lateral bone length
timeFrame: Immediately after surgery, and 6 months after surgery
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Stomatology Hospital, School of Stomatology, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References: