- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04625192
Trephine Osteotomy in Lateral Sinus Lift
Lateral Sinus Lift Technique Using Trephine Osteotomy With Simultaneous Implant Placement (Clinical Trial)
Study Overview
Detailed Description
The study includes 14 patients in whom the lateral sinus lift technique was performed using the trephine osteotomy with simultaneous implant placement.
Sinus floor augmentation with autogenous bone graft resulting from implant site preparation with trephine drills.
Implant stability and rate of complications such as Schneiderian membrane perforation and bleeding will be assessed.
Patients will also provide their subjective assessment of postoperative pain and swelling. Vertical bone height, that will be gained, will be assessed radiographically
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Alexandria, Egypt
- Faculty of Dentistry, Alexandria University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients of both genders requiring implant placement in the posterior maxilla.
- Age between 20-50 years.
- Tooth extractions at the implant sites were performed at least 4 months before surgery.
- Residual bone height between the alveolar bone crest and the sinus floor ranges from 4 to 6 mm.
- Patients who are willing and fully capable to comply with the study protocol
Exclusion Criteria:
- Maxillary sinus pathologies (sinusitis, long standing nasal obstruction)
- Any disease contraindicating surgery (e.g. uncontrolled diabetes)
- Heavy smokers
- Acute oral infections
- Poor oral hygiene
- A history of radiotherapy or chemotherapy of the head and neck region
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sinus lifting with trephine osteotomy
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|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Implant stability
Time Frame: at baseline and 6 months
|
This will be measured by implant stability meter (OsstellTM)
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at baseline and 6 months
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change in bone density
Time Frame: at baseline, 3rd and 6th months
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Panoramic radiography will be performed immediately postoperatively and cone beam computed tomography (CBCT)
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at baseline, 3rd and 6th months
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change in bone volume
Time Frame: at baseline, 3rd and 6th months
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Panoramic radiography will be performed immediately postoperatively and cone beam computed tomography (CBCT)
|
at baseline, 3rd and 6th months
|
change in bone vertical bone height
Time Frame: at baseline, 3rd and 6th months
|
Panoramic radiography will be performed immediately postoperatively and cone beam computed tomography (CBCT)
|
at baseline, 3rd and 6th months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
post operative pain
Time Frame: after 1 week
|
This will be assessed using a 10-point Visual Analogue Scale (VAS) in the 1st week postoperatively. (0-1=None, 2-4=Mild-Moderate, 8-10= Severe) |
after 1 week
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Postoperative edema
Time Frame: after 1 week
|
|
after 1 week
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Trephine osteotomy
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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