Clinical trial NCT05315791: Clinical Application Strategies of Maxillary Sinus Buccal Bony Window
Official title: Clinical Application Strategies of Maxillary Sinus Buccal Bony Window With Different Residual Bone Heights in Lateral Maxillary Sinus Floor Elevation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sinus Floor Augmentation
Maxillary Sinus
Keywords: maxillary sinus floor elevation
CBCT
RCT
Lead sponsor: The Dental Hospital of Zhejiang University School of Medicine
Sponsor class: OTHER
First posted: 2022-04-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Through randomized controlled trials, investigators will recruit participants who need maxillary sinus floor elevation with different residual bone height, and utilize the maxillary sinus buccal bony window during the surgery. Then investigators will gather the related information of participants, collect and analyze their CBCT data, in order to help surgeons select the best operating method for different patients.

Detailed description: Through randomized controlled trials, investigators will recruit 60 participants who need maxillary sinus floor elevation with different residual bone height (0\~3mm; 3\~5mm), and utilize the maxillary sinus buccal bony window during the surgery (A: ground into pieces; B: replace the bone; C: turn inward to hold up the membrane). Then investigators will gather the related information of participants, collect and analyze their CBCT data, in order to help surgeons select the best operating method for different patients.

Eligibility criteria: Inclusion Criteria:

* A single maxillary posterior tooth was missing, and the missing time was ≥ 3 months
* Gingival distance ≥ 4mm
* Residual bone height ≤ 5mm and residual bone width ≥ 6mm
* Good systemic health
* CBCT image was complete and clear, and there was no obvious artifact affecting the measurement
* Informed consent.

Exclusion Criteria:

* Untreated diabetes or other serious systemic diseases
* Untreated periodontal disease
* Uncontrolled periapical lesions of adjacent teeth
* Certain bone diseases such as osteoporosis and osteosclerosis
* Severe night bruxism
* Mental illness
* Pregnant or breast-feeding patients.

Primary outcomes:
measure: ABH change
timeFrame: baseline, 6 months, and 1, 2, 3, 5, 10 years after the surgery
measure: ESBG change
timeFrame: baseline, 6 months, and 1, 2, 3, 5, 10 years after the surgery
measure: RBH
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Affiliated Hospital of Stomatology, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References:
citation: Starch-Jensen T, Jensen JD. Maxillary Sinus Floor Augmentation: a Review of Selected Treatment Modalities. J Oral Maxillofac Res. 2017 Sep 30;8(3):e3. doi: 10.5037/jomr.2017.8303. eCollection 2017 Jul-Sep.
citation: Niu L, Wang J, Yu H, Qiu L. New classification of maxillary sinus contours and its relation to sinus floor elevation surgery. Clin Implant Dent Relat Res. 2018 Aug;20(4):493-500. doi: 10.1111/cid.12606. Epub 2018 Apr 25.
citation: Zhou Y, Shi Y, Si M, Wu M, Xie Z. The comparative evaluation of transcrestal and lateral sinus floor elevation in sites with residual bone height </=6 mm: A two-year prospective randomized study. Clin Oral Implants Res. 2021 Feb;32(2):180-191. doi: 10.1111/clr.13688. Epub 2020 Dec 26.