Clinical Application Strategies of Maxillary Sinus Buccal Bony Window

Not Applicable

Recruiting

• Conditions: Maxillary Sinus; Sinus Floor Augmentation

• Registration Number: NCT05315791
• Lead Sponsor: The Dental Hospital of Zhejiang University School of Medicine

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.

Study Timeline

• Status Verified: 2022-03
• Study Start: 2022-03-10
• Study First Submitted: 2022-03-12
• Study First Submitted QC: 2022-03-30
• Last Update Submitted: 2022-03-30
• Study First Posted: 2022-04-07
• Last Update Posted: 2022-04-07
• Primary Completion: 2023-03-02
• Study Completion: 2032-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
ESBG change	baseline, 6 months, and 1, 2, 3, 5, 10 years after the surgery	Endo-sinus bone gain (ESBG): ESBG = ABH + implant protrusion length at baseline; ESBG represented the grafted height and neo-formed bone, and described the height difference of radiopaque area in the sinus cavity at different times.
RBH	baseline	Residual bone height (RBH): Only assessed at baseline
ABH change	baseline, 6 months, and 1, 2, 3, 5, 10 years after the surgery	Apical bone height (ABH): Represented the grafted height at baseline and the grafted height with neo-formed bone at follow-ups.

Trial Locations

Locations (1)

The Affiliated Hospital of Stomatology, Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China