Sinus Lift Using PTFE Titanium Reinforced Membrane
Evaluation of Direct Sinus Lift Using Ptfe Titanium Reinfored Membrane Assosiated With Immediate Implant Placement (Clinical Trial)
1 other identifier
interventional
12
1 country
1
Brief Summary
Various attempts have been implemented using different materials and techniques to augment the maxillary sinus floor enhancing autogenous bone formation to allow proper dental implant positioning. The aim of this study is to evaluate the sinus lift procedure using polytetrafluoroethylene (PTFE) titanium-reinforced membrane to maintain the space formed after Schneiderian membrane elevation followed by immediate 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 Sep 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
September 1, 2020
CompletedFirst Submitted
Initial submission to the registry
September 6, 2021
CompletedFirst Posted
Study publicly available on registry
September 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2021
CompletedSeptember 14, 2021
September 1, 2021
1.1 years
September 6, 2021
September 6, 2021
Conditions
Outcome Measures
Primary Outcomes (4)
Change in implant stability
It will be measured using Osstell
at baseline and 6 months
Change in bone formation
It will be measured uisng CBCT on Demand 3d software
at baseline and 6 months
Change in bone height
It will be measured uisng CBCT on Demand 3d software
at baseline and 6 months
Change in bone density
It will be measured uisng CBCT on Demand 3d software
at baseline and 6 months
Study Arms (1)
Direct Sinus elevation using SLA Kit
EXPERIMENTALInterventions
Implants will be placed immediately after sinus lifting procedure and maintaining the sinus membrane in position using PTFE titanium reinforced membrane.
Eligibility Criteria
You may qualify if:
- Patients of both genders requiring implant placement in posterior maxilla
- Age range: 40-60 years.
- Good oral hygiene
- Healthy maxillary sinus free from pathology
- The minimum crestal bone height is (4-6) mm
- Patients who are willing and fully capable to comply with the study protocol.
You may not qualify if:
- Sinus infection
- Tumors or pathologic lesions in sinus
- Severe allergic rhinitis.
- Chronic topical steroid use.
- Radiation therapy.
- Psychologic / mental impairment
- Acute infection (periodontitis or mucosal infection
- Patients on radiotherapy or chemotherapy.
- Alcohol or drug abuse.
- Patient with systemic disorder (uncontrolled Diabetes mellitus, autoimmune diseases, bone diseases, etc.)
- Smokers
- Parafuctional habits
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Alexandria Faculty of Dentistry
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
September 6, 2021
First Posted
September 14, 2021
Study Start
September 1, 2020
Primary Completion
October 20, 2021
Study Completion
October 20, 2021
Last Updated
September 14, 2021
Record last verified: 2021-09