Clinical Application Strategies of Maxillary Sinus Buccal Bony Window

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Application Strategies of Maxillary Sinus Buccal Bony Window With Different Residual Bone Heights in Lateral Maxillary Sinus Floor Elevation

Conditions
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Sinus Floor Augmentation, Maxillary Sinus

Intervention / Treatment
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* Procedure: different methods for maxillary sinus floor elevation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: a: ground into pieces<br>0 3mm | Procedure: different methods for maxillary sinus floor elevation<br>* a: 0 3mm+ground into pieces; b: 0 3mm+replace the bone; c: 0 3mm+turn inward to hold up the membrane; d: 3 5mm+ground into pieces; e: 3 5mm+replace the bone; f: 3 5mm+turn inward to hold up the membrane<br>|
| Experimental: b: replace the bone<br>0 3mm | Procedure: different methods for maxillary sinus floor elevation<br>* a: 0 3mm+ground into pieces; b: 0 3mm+replace the bone; c: 0 3mm+turn inward to hold up the membrane; d: 3 5mm+ground into pieces; e: 3 5mm+replace the bone; f: 3 5mm+turn inward to hold up the membrane<br>|
| Experimental: c: turn inward<br>0 3mm | Procedure: different methods for maxillary sinus floor elevation<br>* a: 0 3mm+ground into pieces; b: 0 3mm+replace the bone; c: 0 3mm+turn inward to hold up the membrane; d: 3 5mm+ground into pieces; e: 3 5mm+replace the bone; f: 3 5mm+turn inward to hold up the membrane<br>|
| Experimental: d: ground into pieces<br>3 5mm | Procedure: different methods for maxillary sinus floor elevation<br>* a: 0 3mm+ground into pieces; b: 0 3mm+replace the bone; c: 0 3mm+turn inward to hold up the membrane; d: 3 5mm+ground into pieces; e: 3 5mm+replace the bone; f: 3 5mm+turn inward to hold up the membrane<br>|
| Experimental: e: replace the bone<br>3 5mm | Procedure: different methods for maxillary sinus floor elevation<br>* a: 0 3mm+ground into pieces; b: 0 3mm+replace the bone; c: 0 3mm+turn inward to hold up the membrane; d: 3 5mm+ground into pieces; e: 3 5mm+replace the bone; f: 3 5mm+turn inward to hold up the membrane<br>|
| Experimental: f: turn inward<br>3 5mm | Procedure: different methods for maxillary sinus floor elevation<br>* a: 0 3mm+ground into pieces; b: 0 3mm+replace the bone; c: 0 3mm+turn inward to hold up the membrane; d: 3 5mm+ground into pieces; e: 3 5mm+replace the bone; f: 3 5mm+turn inward to hold up the membrane<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ABH change | Apical bone height (ABH): Represented the grafted height at baseline and the grafted height with neo-formed bone at follow-ups. | baseline, 6 months, and 1, 2, 3, 5, 10 years after the surgery | 
| ESBG change | 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. | baseline, 6 months, and 1, 2, 3, 5, 10 years after the surgery | 
| RBH | Residual bone height (RBH): Only assessed at baseline | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CBCT, maxillary sinus floor elevation, RCT