Titanium Platelet-rich Fibrin in Sinus Floor Elevation Through Flapless Transcrestal Approach

Study Overview
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Brief Summary
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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).

Official Title
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Evaluation of the Use of Titanium Platelet-rich Fibrin in Sinus Floor Elevation Through Flapless Transcrestal Approach ( a Randomized Controlled Clinical Trial)

Conditions
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Sinus Floor Elevation

Intervention / Treatment
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* Other: Flapless transcrestal sinus lift approach with TPRF
* Other: Flapless transcrestal sinus lift approach with PRF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Uncontrolled Diabetes. Coagulation disorders. Immunological disorders. Previous radiation of the head and neck region. Abnormal bone physiology. Therapy with Bisphosphonates.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br> | Other: Flapless transcrestal sinus lift approach with TPRF<br>* Including 8 patients who will be treated by flapless transcrestal sinus floor elevation using the TPRF as a sole grafting material.<br>|
| Active Comparator: Control gorup<br> | Other: Flapless transcrestal sinus lift approach with PRF<br>* Including 8 patients who will be treated by flapless transcrestal sinus floor elevation using the PRF as a sole grafting material.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in implant stability | Secondary implant stability will be measured 6 months post-operatively using Osstell device. | Baseline and 6 months | 
| change in pain scores | Pain (by Visual Analogous Scale) ranges from 0 to 10 0 - No pain. 2 to 4 - Mild pain. 5 to 7 - Moderate pain. 8 to 10 - severe pain. | 1st day, 3rd day and 1 week |