Titanium Platelet-rich Fibrin in Sinus Floor Elevation Through Flapless Transcrestal Approach
Evaluation of the Use of Titanium Platelet-rich Fibrin in Sinus Floor Elevation Through Flapless Transcrestal Approach ( a Randomized Controlled Clinical Trial)
1 other identifier
interventional
16
1 country
1
Brief Summary
Dental implant therapy in the posterior maxilla may be difficult owing to limited bone height after dental extraction with sinus pneumatization. Several approaches for sinus floor elevation have been documented, and hence flapless transcrestal sinus floor elevation is minimally invasive technique which is used in moderately defected maxilla. Aim of the study: to evaluate both clinical and radiographic outcomes in sinus floor elevation following dental implant placement using flapless transcrestal sinus lift approach with Titanium platelet rich fibrin (TPRF) as a sole sinus graft material compared to Platelet rich fibrin (PRF).
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 Mar 2022
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
March 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2023
CompletedFirst Submitted
Initial submission to the registry
February 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 5, 2023
CompletedFirst Posted
Study publicly available on registry
February 10, 2023
CompletedFebruary 21, 2023
February 1, 2023
11 months
February 1, 2023
February 20, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Change in bone density
Cuts of CBCT (cross sectional, axial and sagittal view), bone density, will be analyzed using On-demand software. The radiographic evaluation will be based on radiological parameters, using reference points and lines at T0 and T1.
Baseline and 6 months
Secondary Outcomes (2)
Change in implant stability
Baseline and 6 months
change in pain scores
1st day, 3rd day and 1 week
Study Arms (2)
Study group
EXPERIMENTALControl gorup
ACTIVE COMPARATORInterventions
Including 8 patients who will be treated by flapless transcrestal sinus floor elevation using the TPRF as a sole grafting material.
Including 8 patients who will be treated by flapless transcrestal sinus floor elevation using the PRF as a sole grafting material.
Eligibility Criteria
You may qualify if:
- Patient seeking replacement of a missed maxillary posterior teeth by a delayed dental implant procedure.
- Residual bone height is (4-7) mm measured from crestal bone to sinus floor.
- Good oral hygiene
You may not qualify if:
- Uncontrolled Diabetes.
- Coagulation disorders.
- Immunological disorders.
- Previous radiation of the head and neck region.
- Abnormal bone physiology.
- Therapy with Bisphosphonates.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Alexandria Faculty of Dentistry
Alexandria, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant lecturer of DPH and Clinical statistician
Study Record Dates
First Submitted
February 1, 2023
First Posted
February 10, 2023
Study Start
March 15, 2022
Primary Completion
January 30, 2023
Study Completion
February 5, 2023
Last Updated
February 21, 2023
Record last verified: 2023-02