Trephine Osteotomy in Lateral Sinus Lift
Lateral Sinus Lift Technique Using Trephine Osteotomy With Simultaneous Implant Placement (Clinical Trial)
1 other identifier
interventional
14
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2020
CompletedFirst Submitted
Initial submission to the registry
November 6, 2020
CompletedFirst Posted
Study publicly available on registry
November 12, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2021
CompletedNovember 12, 2020
November 1, 2020
12 months
November 6, 2020
November 6, 2020
Conditions
Outcome Measures
Primary Outcomes (4)
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 Outcomes (2)
post operative pain
after 1 week
Postoperative edema
after 1 week
Study Arms (1)
Sinus lifting with trephine osteotomy
EXPERIMENTALInterventions
* 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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Dentistry, Alexandria University
Alexandria, Egypt
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant lecturer of DPH and Clinical statistician
Study Record Dates
First Submitted
November 6, 2020
First Posted
November 12, 2020
Study Start
February 1, 2020
Primary Completion
January 30, 2021
Study Completion
January 30, 2021
Last Updated
November 12, 2020
Record last verified: 2020-11