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Completed

NCT Number: NCT05721612

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

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).

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Key information

Conditions

Sinus Floor Elevation

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alexandria Faculty of Dentistry

Alexandria, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Flapless transcrestal sinus lift approach with TPRF

Other

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

Flapless transcrestal sinus lift approach with PRF

Other

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

Primary outcomes

  1. Change in bone density

    Time frame: 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 outcomes

  1. Change in implant stability

    Time frame: Baseline and 6 months

    Secondary implant stability will be measured 6 months post-operatively using Osstell device.

  2. change in pain scores

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hams Hamed Abdelrahman

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 10, 2023
Registry last updated
Feb 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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