Comparing two techniques for lifting the maxillary sinus floor during dental implant placement
Osseodensification Versus Osteotome Internal Sinus Lifting in Delayed Implant Placement (A Randomized Controlled Clinical Trial)
This study is testing two different methods for lifting the maxillary sinus during dental implant surgery to see which one works better for patients with missing teeth in the upper jaw.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | Ain Shams University Academic / other |
| Drugs / interventions | Chemotherapy, radiation |
| Locations | 2 sites (Asyut and 1 other locations) |
| Trial ID | NCT05495490 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the efficacy of two techniques for maxillary sinus floor augmentation: Osseodensification and Osteotome internal sinus lifting. Twenty patients with a maxillary posterior edentulous ridge will be randomly assigned to either technique, utilizing sticky bone as graft material. Pre-surgical evaluations will include Cone Beam Computed Tomography (CBCT) to assess sinus anatomy and residual ridge dimensions. Post-surgery, the study will evaluate bone gain, bone density, and implant stability, alongside patient-reported outcomes regarding pain and recovery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 40 with a partially edentulous maxillary posterior ridge and a residual alveolar ridge height of 4 to 6 mm.
Not a fit: Patients with smoking habits, uncontrolled systemic diseases, or those with acute or chronic sinus issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve dental implant outcomes and patient comfort during sinus lift procedures.
How similar studies have performed: While similar techniques have been explored, this specific comparison of Osseodensification and Osteotome internal sinus lifting is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\. Patient partially edentulous with maxillary posterior edentulous ridge after extraction of more than 4 months. 2\. Both sexes will be selected males and females. 3\. Adult patients aged between 18 and 40 years of age. 4\. Good general health (American Society of Anesthesiology Physical Status Ⅰ-Ⅱ). 5\. Initial residual alveolar ridge height ranging between 4 to 6 mm according to preoperative CBCT. 6\. No previous surgery or radiation treatment on the maxillary sinus. Exclusion Criteria: * 1\. Smokers. 2\. Pregnant or lactating females. 3\. Psychiatric disorders. 4\. Uncontrolled systemic disease. 5\. Hematologic diseases and coagulation disorders. 6\. Chemotherapy or radiotherapy of the head and neck area, and immunocompromised status. 7\. Medical conditions affecting bone metabolism and ongoing treatment with bisphosphonates drugs or systemic steroids. 8\. Presence of acute or chronic sinus pathoses or sinus membrane perforation.
Where this trial is running
Asyut and 1 other locations
- Faculty of Dentistry- Assiut University — Asyut, Egypt (Recruiting)
- Faculty of Dentistry- Ain Shams University — Cairo, Egypt (Recruiting)
Study contacts
- Principal investigator: Omneya M. Elkadi — Faculty of Dentistry- Ain Shams University
- Study coordinator: Omneya M. Elkadi, Ass.Lecturer
- Email: ninielkadi@gmail.com
- Phone: 00201121844448
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.