Maxillary Sinus, Sinus Floor Augmentation
Conditions
Keywords
maxillary sinus floor elevation, CBCT, RCT
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.
Interventions
PROCEDUREdifferent methods for maxillary sinus floor elevation
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
Sponsors
The Dental Hospital of Zhejiang University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
Countries
China
Outcome results
None listed