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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06360263
Other study ID # #1-6/2023
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 11, 2023
Est. completion date August 2024

Study information

Verified date April 2024
Source Alexandria University
Contact Esraa S Kamal, BDS
Phone 106 054 3345
Email esraasalemkamal@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 6
Est. completion date August 2024
Est. primary completion date August 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years to 60 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Combination Product:
Densah bur in combination with activated plasma albumin gel
Simultaneous implant placement after transcrestal maxillary sinus lifting using densah burs in combination with activated plasma albumin gel.(APAG). A full mucoperiosteal flap will be elevated, and then reflected with periosteal elevator application of first densah bur (the narrowest) with densifying mood (reverse) counterclockwise, 800-1500 revolutions per minute with copious irrigation until the sinus is reached confirm bur position with a radiograph. Then a wider densah bur (3.0) is used with the same mode and bouncing motion to elevate the sinus floor up to 3 mm in 1mm increments.The sequential densah bur will be used with the same mode and bouncing motion to elevate the the sinus floor 3 mm maximum. After achieving the final planned osteotomy diameter, the osteotomy will be filled with APAG. Then, the desired implant length is inserted.

Locations

Country Name City State
Egypt Faculty of Dentistry, Alexandria University Alexandria

Sponsors (1)

Lead Sponsor Collaborator
Esraa Salem Kamal

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative pain This will be assessed using a 10-point Visual Analogue Scale (VAS). (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe) up to one week
Primary Implant stability 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. up to 6 months
Primary Vertical bone height gain 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. up to 6 months
Primary Bone density around implant 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 up to 6 months
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