Clinical Application Strategies of Maxillary Sinus Buccal Bony Window
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorThe Dental Hospital of Zhejiang University School of Medicine
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Untreated diabetes or other serious systemic diseases
Untreated periodontal disease
Uncontrolled periapical lesions of adjacent teeth
Certain bone diseases such as osteoporosis and osteosclerosis
Trial design
Design model
Parallel
Treatments tested in this trial
different methods for maxillary sinus floor elevation
Procedure/Surgerya: 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
Treatment groups
60 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: a: ground into piecesExperimental treatment 1 intervention
Group B: b: replace the boneExperimental treatment 1 intervention
Group C: c: turn inwardExperimental treatment 1 intervention
Group D: d: ground into piecesExperimental treatment 1 intervention
Group E: e: replace the boneExperimental treatment 1 intervention
Group F: f: turn inwardExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
ABH change
Apical bone height (ABH): Represented the grafted height at baseline and the grafted height with neo-formed bone at follow-ups.
Time frame
baseline, 6 months, and 1, 2, 3, 5, 10 years after the surgery2
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.
Time frame
baseline, 6 months, and 1, 2, 3, 5, 10 years after the surgery3
RBH
Residual bone height (RBH): Only assessed at baseline
Time frame
baselineSponsors and contacts
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Source ClinicalTrials.gov