Non-grafted Maxillary Sinus Floor Elevation With Simultaneous Implant Placement Using Different Implant Lengths
1 other identifier
interventional
20
0 countries
N/A
Brief Summary
twenty recruited patients indicated for sinus augmentation and simultaneous implant placement will be divided into two groups (10 in each of the groups).to evaluate \& compare bone formation \& implant stability after shneiderian membrane elevation and augmentation with graft less tenting technique with different implant lengths. group one will receive 8mm implant lenght while group two will receive 10mm implants.
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 Jan 2019
Shorter than P25 for not_applicable
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
First Submitted
Initial submission to the registry
September 12, 2018
CompletedFirst Posted
Study publicly available on registry
November 6, 2018
CompletedStudy Start
First participant enrolled
January 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2019
CompletedNovember 6, 2018
November 1, 2018
7 months
September 12, 2018
November 3, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
height of gained bone
two cone beam CT will be done for the patients, one immediate post operative \& the other 6 months post operative then the amount of gained bone will be assessed by superimposing the same section in the two cone beam CT.
6 months post operative
Secondary Outcomes (1)
implant stability
will be measured intra operative after implant insertion and will be measured once more 6 months post operative after the first operation at the time of implant exposure
Study Arms (2)
active comparator
EXPERIMENTALplacebo
EXPERIMENTALInterventions
non grafted maxillary sinus floor augmentation with simultaneous implant placement
Eligibility Criteria
You may qualify if:
- patient with atrophic maxilla \& pneumatized maxillary sinus with residual bone height at least 4mm of residual ridge
- both sexes
You may not qualify if:
- patients with systematic diseases that may affect normal healing
- sinus pathology
- heavy smokers more than 20 cigarettes per day
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
September 12, 2018
First Posted
November 6, 2018
Study Start
January 1, 2019
Primary Completion
August 1, 2019
Study Completion
August 15, 2019
Last Updated
November 6, 2018
Record last verified: 2018-11