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Clinical Trials/NCT06360263
NCT06360263
Completed
Not Applicable

OSSEODENSIFICATION BY DENSAH BURS IN COMBINATION WITH ACTIVATED PLASMA ALBUMIN GEL FOR TRANSCRESTAL MAXILLARY SINUS LIFTING WITH SIMULTANEOUS IMPLANT PLACEMENT (CLINICAL TRIAL)

Esraa Salem Kamal1 site in 1 country6 target enrollmentJuly 10, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bone Loss, Alveolar
Sponsor
Esraa Salem Kamal
Enrollment
6
Locations
1
Primary Endpoint
Implant stability
Status
Completed
Last Updated
last year

Overview

Brief Summary

Aim of the current study is to evaluate clinically and radiographically transcrestal sinus lifting with densah burs with the use of activated plasma albumin gel associated with simultaneous implant placement.

Registry
clinicaltrials.gov
Start Date
July 10, 2023
End Date
July 10, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Esraa Salem Kamal
Responsible Party
Sponsor Investigator
Principal Investigator

Esraa Salem Kamal

Oral and Maxillofacial Surgery MSc Candidate

Alexandria University

Eligibility Criteria

Inclusion Criteria

  • Patient with missing maxillary premolars and molars.
  • Vertical bone height of 3-5 mm.
  • Good oral hygiene.
  • Non smokers.

Exclusion Criteria

  • Bad oral hygiene.
  • Presence of infection or periapical lesions in adjacent teeth.
  • Acute maxillary sinusitis.
  • Bruxism or clenching.
  • Medically compromised patients with a condition that affects the procedure (patients with bone diseases such as osteogenesis imperfecta and polyarthritis and patients on radiotherapy and chemotherapy)

Outcomes

Primary Outcomes

Implant stability

Time Frame: up to 6 months

Resonance frequency analysis is based on determining whether or not an implant is stable enough. The result is presented as an ISQ value of 1-100. The higher the ISQ, the more stable the implant.

Postoperative pain

Time Frame: up to one week

This will be assessed using a 10-point Visual Analogue Scale (VAS). (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe)

Vertical bone height gain

Time Frame: up to 6 months

To determine the amount of bone height gain, cone beam computed tomography (CBCT) scans will be taken immediately and after 6 months. Amount of bone height gain will be measured linearly in millimeter by determine the difference between residual bone height and bone height above the implant immediately and 6 months postoperatively in anteroposterior and mediolateral dimensions.

Bone density around implant

Time Frame: up to 6 months

This will be measured from CBCT scans in grayscale using a software. Densitometric analysis will be performed around dental implants on CBCT image using the software supplied with the machine. This analysis gives the actual bone density around the immersed dental implant that proves the process of osseointegration. Higher values indicate better results

Study Sites (1)

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