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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)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05721612
Enrollment
16
Registered
2023-02-10
Start date
2022-03-15
Completion date
2023-02-05
Last updated
2023-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sinus Floor Elevation

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).

Interventions

OTHERFlapless transcrestal sinus lift approach with TPRF

Including 8 patients who will be treated by flapless transcrestal sinus floor elevation using the TPRF as a sole grafting material.

OTHERFlapless transcrestal sinus lift approach with PRF

Including 8 patients who will be treated by flapless transcrestal sinus floor elevation using the PRF as a sole grafting material.

Sponsors

Hams Hamed Abdelrahman
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
25 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in bone densityBaseline and 6 monthsCuts 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

MeasureTime frameDescription
Change in implant stabilityBaseline and 6 monthsSecondary implant stability will be measured 6 months post-operatively using Osstell device.
change in pain scores1st day, 3rd day and 1 weekPain (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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026