Sinus Lift With Hydroxyapatite Nano Particles Versus Tenting Technique
Schneiderian Membrane Elevation and Augmentation With Hydroxyapatite Nano Particles [ Nano Streams ] Versus Graft Less Tenting Technique With Simultaneous Implant Placement: Randomized Clinical Trial
1 other identifier
interventional
20
0 countries
N/A
Brief Summary
twenty recruited patients indicated for sinus augmentation and immediate implant placement will be divided into two groups (10 in each of the two groups), to compare bone formation and implant stability after shneiderian membrane elevation and augmentation with Hydroxyapatite Nano particles \[Nanostreams\] or augmentation with graft less tenting technique with simultaneous implant placement.
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 Jul 2016
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
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 19, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedFirst Posted
Study publicly available on registry
June 6, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedJune 6, 2017
June 1, 2017
11 months
May 19, 2017
June 5, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
patient satisfaction
evaluation of post operative complications in terms of pain and edema using patient pain chart
7 days post operative
Secondary Outcomes (2)
implant stability
will be measured intra-operative after implant insertion and will be measured one more time 6 months after the first operation at the time of implant exposure
height of bone gain or loss around the implant
6 months post operative
Study Arms (2)
sinus lift implant placement Hydroxyapatite Nano particles
EXPERIMENTALshneiderian membrane elevation and augmentation with Hydroxyapatite Nano particles \[Nanostreams\] with simultaneous implant placement
sinus lift implant placement tenting
ACTIVE COMPARATORshneiderian membrane elevation and augmentation with graft less tenting technique with simultaneous implant placement
Interventions
shneiderian membrane elevation and augmentation with Hydroxyapatite Nano particles with simultaneous implant placement
shneiderian membrane elevation and augmentation with graft less tenting technique with simultaneous implant placement
Eligibility Criteria
You may qualify if:
- Patients with atrophic maxilla and pneumatization of the maxillary sinus with residual bone height at least 5mm of residual ridge as per MISCH criteria
- Both sexes
You may not qualify if:
- Sinus pathology
- Heavy smokers more than 20 cigarettes per day
- Patients with systemic disease that may affect normal healing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
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
- Doctor
Study Record Dates
First Submitted
May 19, 2017
First Posted
June 6, 2017
Study Start
July 1, 2016
Primary Completion
June 1, 2017
Study Completion
July 1, 2017
Last Updated
June 6, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will share