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Completed

NCT Number: NCT06135077

Titanium Prepared Platelet-rich Fibrin in Bone Regeneration in Lateral Window Maxillary Sinus Augmentation

This trial aims to evaluate the effect of the sole use of T-PRF in bone formation process as applied in maxillary sinus floor elevation in comparison to traditional T-PRF/bone graft combination.

This study is clinical trial that will include 18 patients seeking implant placement in upper posterior maxilla compromised with maxillary sinus pneumatization. Patients will be assigned into control and test groups. All the patients will undergo sinus lifting procedure through which a combination of xenograft and T-PRF was used in the control group whereas; sole T-PRF will be applied in the test group.

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Key information

Conditions

Sinus Lifting

Age range

18 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Systemically in a healthy condition.
  • Residual bone height is ≤5mm in the posterior maxilla as measured with CBCT.
  • Non-smokers.
  • Good oral hygiene as indicated by plaque and bleeding scores

Exclusion criteria

  • Medically compromised conditions will be excluded to avoid infections or any adverse reaction related to immunity suppression.
  • Acute maxillary sinusitis.
  • Patients administering any antibiotics or regular anti-inflammatory drugs.

Treatment and study plan

T-PRF alone

Other

T-PRF is the material to be tested in this study as an alternative to classical bone graft

T-PRF/Xenograft

Other

One part of T-PRF will be divided into minute pieces to be mixed with xenograft

Primary outcomes

  1. Change in pain level

    Time frame: up to 2 weeks

    measuring level of pain using visual analog scale (VAS) 0-10, where 0 reading indicates no pain and 10 reading reflects the most severe pain.

  2. Change in bone volume

    Time frame: up to 3 months

    pre opertaive and post operative CBCT

  3. Change in bone denisty

    Time frame: up to 3 months

    pre opertaive and post operative CBCT

  4. Change in bone height

    Time frame: up to 3 months

    pre opertaive and post operative CBCT

Sponsors and collaborators

Lead sponsor

Hams Hamed Abdelrahman

Other

Registry information

Official study title

Evaluation of Titanium-prepared Platelet-rich Fibrin in Bone Regeneration in Lateral Window Maxillary Sinus Augmentation (Clinical Trial)

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 18, 2023
Registry last updated
Nov 18, 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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