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

Not Applicable

Completed

• Conditions: Sinus Floor Elevation
• Interventions: Other: Flapless transcrestal sinus lift approach with TPRF; Other: Flapless transcrestal sinus lift approach with PRF

• Registration Number: NCT05721612
• Lead Sponsor: Hams Hamed Abdelrahman

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-15
• Primary Completion: 2023-01-30
• Status Verified: 2023-02
• Study First Submitted: 2023-02-01
• Study First Submitted QC: 2023-02-01
• Study Completion: 2023-02-05
• Study First Posted: 2023-02-10
• Last Update Submitted: 2023-02-20
• Last Update Posted: 2023-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group	Flapless transcrestal sinus lift approach with TPRF	-
Control gorup	Flapless transcrestal sinus lift approach with PRF	-

Primary Outcome Measures

Name	Time	Method
Change in bone density	Baseline and 6 months	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.

Secondary Outcome Measures

Name	Time	Method
Change in implant stability	Baseline and 6 months	Secondary implant stability will be measured 6 months post-operatively using Osstell device.
change in pain scores	1st day, 3rd day and 1 week	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.

Trial Locations

Locations (1)

Alexandria Faculty of Dentistry; 🇪🇬 Alexandria, Egypt