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Clinical Trials/NCT05831267
NCT05831267
Completed
Not Applicable

Fibrin Glue Versus Titanium Platelet-rich Fibrin as a Sole Filling Material in Lateral Sinus Lifting With Simultaneous Implant Placement (Randomized Controlled Clinical Trial )

Hams Hamed Abdelrahman1 site in 1 country30 target enrollmentFebruary 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sinus Floor Augmentation
Sponsor
Hams Hamed Abdelrahman
Enrollment
30
Locations
1
Primary Endpoint
change in bone density
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Graftless sinus lift with simultaneous implant placement is one of the new techniques, this new technique is presented based on the physiology of intrasinus bone repair.

Schneiderian membrane is known to have an osteogenic nature, now blood clot can be considered autologous osteogenic graft material, to which osteoprogenitors can migrate, differentiate, and regenerate bone.

The aim of this study is to evaluate the effectiveness of using Fibrin glue versus Titanium platelet rich fibrin (T-PRF) as a sole filling material in lateral sinus lifting using with simultaneous implant placement in comparison to a negative control group.

Registry
clinicaltrials.gov
Start Date
February 1, 2022
End Date
September 30, 2022
Last Updated
3 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

  • Patients requiring implant placement in the posterior maxilla.
  • Tooth extractions at the implant sites were performed at least 4 months before surgery.
  • Residual bone height between the alveolar bone crest and the sinus floor is 3-5 mm

Exclusion Criteria

  • Maxillary sinus pathologies (sinusitis, long-standing nasal obstruction).
  • Any disease-contraindicating surgery (e.g. uncontrolled diabetes).
  • Heavy smokers (smoke greater than or equal 25 cigarettes daily).
  • Acute oral infections.
  • Untreated periodontal disease (gingival index 2 and 3).
  • Poor oral hygiene ( Silness-Löe index (score 2-3) ).
  • A history of radiotherapy or chemotherapy of the head and neck region.
  • Pregnancy.

Outcomes

Primary Outcomes

change in bone density

Time Frame: Baseline and 6 months

bone density will be measured using CBCT

change in implant stability

Time Frame: Baseline and 6 months

implant stability will be measures using Ostell device.

change in vertical bone height

Time Frame: Baseline and 6 months

vertical bone height will be measured using CBCT

Secondary Outcomes

  • change in pain intensity(Through 1 week postopertaive)
  • Change in edema score(Through 1 week postopertaive)

Study Sites (1)

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