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Clinical Trials/NCT06135077
NCT06135077
Completed
N/A

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

Hams Hamed Abdelrahman1 site in 1 country18 target enrollmentNovember 11, 2021
ConditionsSinus Lifting

Overview

Phase
N/A
Intervention
Not specified
Conditions
Sinus Lifting
Sponsor
Hams Hamed Abdelrahman
Enrollment
18
Locations
1
Primary Endpoint
Change in bone denisty
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
November 11, 2021
End Date
March 21, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Hams Hamed Abdelrahman
Responsible Party
Sponsor Investigator
Principal Investigator

Hams Hamed Abdelrahman

Assistant lecturer of DPH and Clinical statistician

Alexandria University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Change in bone denisty

Time Frame: up to 3 months

pre opertaive and post operative CBCT

Change in bone height

Time Frame: up to 3 months

pre opertaive and post operative CBCT

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.

Change in bone volume

Time Frame: up to 3 months

pre opertaive and post operative CBCT

Study Sites (1)

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