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Clinical Trials/NCT06626776
NCT06626776
Not yet recruiting
Not Applicable

Extended Platelet Rich Fibrin in Lateral Maxillary Sinus Lifting With Simultaneous Implant Placement.

Mansoura University1 site in 1 country30 target enrollmentOctober 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sinus Lift Augmentation
Sponsor
Mansoura University
Enrollment
30
Locations
1
Primary Endpoint
implant stability
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

thirty implants will be inserted in patients seeking implantation of their lost posterior maxillary teeth (premolar and molars) with limited bone height below the floor of the maxillary sinus, secondary to sinus pneumatization. The patients will be selected from those attending the outpatient clinic of the Oral & Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University.

  1. Clinical Evaluation

    • Implant stability

  2. Radiographic Evaluation Vertical bone gain (VBG)

Registry
clinicaltrials.gov
Start Date
October 1, 2024
End Date
October 1, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patent ostium of maxillary sinus.
  • Patient with missing one or more posterior maxillary teeth.
  • Residual bone height of 3-6 mm, measured from the crest of alveolar ridge to the floor of the maxillary sinus at the planned implant site.
  • A ridge width at the site of implantation of \<5mm.
  • Platelets of normal range.
  • Good oral hygiene.
  • Patients in the age frame between 20 years and 60 years old.
  • No gender preface in selection of the patients.
  • A minimum crown height space of 8 mm.

Exclusion Criteria

  • Active sinusitis, cyst, tumors or root tips at the planned surgical site.
  • Patients with systemic diseases that contra-indicate the surgical procedure such as uncontrolled diabetes mellitus, bleeding disorders, serious osseous disorders, and mental disorders.
  • Heavy smoking and alcoholism.
  • Parafunctional habits such as bruxism and clenching.
  • Signs of acute infection or pus discharge.
  • Disturbed occlusion.

Outcomes

Primary Outcomes

implant stability

Time Frame: 9 months

the stability of the implants will be evaluated by RFA with the Osstell Mentor device.

Vertical bone height

Time Frame: 6 months

vertical bone height will be measured as the distance from the alveolar crest to the new sinus floor at the middle of the implant

Study Sites (1)

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