Trephine Osteotomy in Lateral Sinus Lift

Study Overview
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Brief Summary
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Trephine osteotomy was used for lateral sinus lifting technique associated with sinus floor augmentation using the autogenous bone resulting from implant drilling using specialized trephine drills.

Detailed Description
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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

Official Title
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Lateral Sinus Lift Technique Using Trephine Osteotomy With Simultaneous Implant Placement (Clinical Trial)

Conditions
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Sinus Lift

Intervention / Treatment
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* Procedure: Trephine osteotomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sinus lifting with trephine osteotomy<br> | Procedure: Trephine osteotomy<br>* Using a trephine on a straight implant handpiece (at approximately 1800 rpm) with copious irrigation to avoid overheating the bone, a round bone cut will be made 4 -5 mm above the crest of the alveolar ridge. The trephine is positioned perpendicular to the lateral wall, removing the outer cortex with a very gentle touch to avoid tearing the schneiderian membrane.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Implant stability | This will be measured by implant stability meter (OsstellTM) | at baseline and 6 months | 
| change in bone density | Panoramic radiography will be performed immediately postoperatively and cone beam computed tomography (CBCT) | at baseline, 3rd and 6th months | 
| change in bone volume | 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 | 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 | 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 | 
| Postoperative edema | None (no inflammation). Mild (intraoral swelling confined to the surgical field). Moderate (extraoral swelling in the surgical zone). Severe (extraoral swelling spreading beyond the surgical zone | after 1 week |