OSSEODENSIFICATION BY DENSAH BURS WITH ACTIVATED PLASMA ALBUMIN GEL FOR SINUS LIFTING WITH SIMULTANEOUS IMPLANT PLACEMENT

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

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.

Study Overview

• Status: Completed
• Conditions: Bone Loss, Alveolar
• Intervention / Treatment: Combination product: Densah bur in combination with activated plasma albumin gel

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Faculty of Dentistry, Alexandria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Sinus lifting using densah bur in combination with activated plasma albumin gel

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Esraa Salem Kamal

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2023
• Primary Completion (Actual): July 10, 2024
• Study Completion (Actual): July 10, 2024

Study Registration Dates

• First Submitted: April 8, 2024
• First Submitted That Met QC Criteria: April 8, 2024
• First Posted (Actual): April 11, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 29, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: transcrestal sinus lifting
• Additional Relevant MeSH Terms: Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Alveolar Bone Loss
• Other Study ID Numbers: #1-6/2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No