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This prospective clinical trial aims to evaluate the efficiency, safety, and reliability of a minimally invasive graftless transcrestal sinus lifting approach with simultaneous dental implant placement in patients with edentulous posterior maxilla and limited residual bone height.
The study investigates bone formation beneath the Schneiderian membrane, implant stability, osseointegration, and long-term implant survival.
This prospective clinical study evaluates a minimally invasive graftless sinus lifting technique using a transcrestal approach with simultaneous implant placement in the posterior maxilla.
The procedure involves tenting the Schneiderian membrane without the use of grafting material, relying on blood clot formation and natural bone regeneration beneath the elevated membrane.
Radiographic and clinical evaluations will be performed preoperatively, immediately postoperatively, and at 6 months to assess bone formation, implant stability, and osseointegration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Graftless Transcrestal Sinus Lift with Simultaneous Implant Placement | Experimental | Participants with edentulous posterior maxilla and residual bone height of approximately 5 mm will undergo minimally invasive graftless transcrestal sinus membrane elevation followed by simultaneous placement of a 10 mm length and 4-4.5 mm diameter dental implant. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Graftless Transcrestal Sinus Membrane Elevation with Simultaneous Implant Placement | Procedure | A minimally invasive transcrestal approach for sinus membrane elevation without graft material, followed by simultaneous placement of a 10 mm length and 4-4.5 mm diameter dental implant in the posterior maxilla with residual bone height of approximately 5 mm. |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of Newly Formed Bone After Graftless Transcrestal Sinus Elevation | Radiographic assessment of the amount of newly formed bone in the elevated sinus space using CBCT. | 6 months after surgery |
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Inclusion Criteria:
Exclusion Criteria:
7. Poor oral hygiene.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oral and Maxillofacial Surgery, Sana'a University | Recruiting | Sanaa | Sanaa Governorate | 00000 | Yemen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38350895 | Result | Albadani MM, Elayah SA, Al-Wesabi MA, Al-Aroomi OA, Al Qadasy NE, Saleh H. A graftless maxillary sinus lifting approach with simultaneous dental implant placement: a prospective clinical study. BMC Oral Health. 2024 Feb 13;24(1):227. doi: 10.1186/s12903-024-03949-9. |
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De-identified individual participant data (IPD) underlying the results reported in this study will be shared after publication. Data will be available upon reasonable request to the corresponding author. Requests must include a methodologically sound proposal and will require approval by the institutional review board. Data will be shared for academic purposes only.
De-identified individual participant data (IPD) and supporting documents will be made available beginning 6 months after publication of the primary results and will remain available for up to 5 years.
Access will be granted to qualified researchers who provide a methodologically sound research proposal. Requests will be reviewed by the principal investigator. Data will be shared after approval and signing of a data use agreement to ensure participant confidentiality.
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| ID | Term |
|---|---|
| D016301 | Alveolar Bone Loss |
| ID | Term |
|---|---|
| D001862 | Bone Resorption |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D055093 | Periodontal Atrophy |
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This is a prospective single-arm clinical study in which all enrolled participants undergo transcrestal graftless sinus membrane elevation with simultaneous dental implant placement. Clinical and radiographic evaluations are performed preoperatively, immediately postoperatively, and at 6 months to assess bone formation and implant stability.
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This is an open-label single-arm prospective clinical study. No masking will be applied to participants, care providers, investigators, or outcome assessors.
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|
| D010510 |
| Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |