Periodontal Disease, Sinusitis
Conditions
Keywords
crestal sinus lift, dental implants, endoscopy, osseodensification, sinus floor augmentation, sinus membrane perforation
Brief summary
This present study will evaluate Schneiderian membrane perforation rates using osseodensification in TSFE with simultaneous graftless implant placement, under sinuscopic control monitored by an ENT specialist. An endoscopic evaluation will be continuously conducted throughout the surgical procedure. TSFE will be performed using Densah burs without the addition of bone graft material, followed by implant placement. The rationale behind this approach is to monitor the response of the Schneiderian membrane and assess the effects of Densah burs on membrane distention and the occurrence of SMP.
Interventions
DEVICEScheiderian Membrane Perforation
Assess endoscopically any Scheiderian membrane perforation while performing transcrestal sinus floor elevation using the densah burs
Sponsors
Saint-Joseph University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Pilot Study
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* males and females over 21 years of age; * partial edentulism in the posterior maxilla involving 2 or more adjacent teeth in the premolar-molar area; * teeth at the intended implant sites must have been extracted or lost at least 9 months before the date of implant surgery; * sinus floor with a relatively flat contour confirmed on baseline CBCT; * bucco-palatal sinus width (distance between the buccal and palatal walls at 10-mm apical level comprising the residual alveolar crest ) 8-12 mm confirmed on baseline CBCT to minimize the risk of SMP during surgery (Stacchi et al. 2022); * sinus membrane thickness ≤ 2 mm; * subsinus residual bone height (RBH) 4-6 mm at the intended implant sites and bucco-palatal bone width allowing implant placement without bone augmentation procedures.
Exclusion criteria
* systemic conditions contraindicating implant surgery; * pregnancy or lactation; * ongoing or history of pathologies or medications affecting bone metabolism; * ongoing or history of head and neck irradiation; * oral inflammatory and autoimmune diseases; * presence of osseous lesions or persistent infections in the planned implant sites; * previous bone augmentation surgery; * uncontrolled periodontal diseases; * heavy smoking (\> 10 cigarettes/day); * history of sinus surgery; * presence of intrasinus bony septa that could affect membrane elevation and distention; and * ongoing or history of rhinitis or sinusitis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of Scheiderian membrane perforation | Perioperative | The primary aim of the present clinical study is to evaluate the incidence of SMP during TSFE with immediate implant placement performed by a trainee surgeon using the osseodensification technique under sinuscopic control in sinuses of comparable contour |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| primary stability achieved by the implants at insertion measured with the insertion torque value, in N.cm | Perioperative | studied in all cases |
| qualitative pattern of membrane distention, differentiated into either a U-shaped dome or a V-shaped dome | Perioperative | Studies in case of SMP occurrence |
| time at which the potential perforation occur | Perioperative | Studies in case of SMP occurrence |
| Size of potential perforations, in mm, classified as pinhole <1mm, small >1mm and <2mm, medium >2mm and < 3mm, large >3mm | Perioperative | Studied in case of SMP occurrence |
Countries
Lebanon
Outcome results
None listed