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

Not Applicable

Completed

• Conditions: Bone Loss, Alveolar
• Interventions: Combination Product: Densah bur in combination with activated plasma albumin gel

• Registration Number: NCT06360263
• Lead Sponsor: Esraa Salem Kamal

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-10
• Study First Submitted: 2024-04-08
• Study First Submitted QC: 2024-04-08
• Study First Posted: 2024-04-11
• Primary Completion: 2024-07-10
• Study Completion: 2024-07-10
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-29
• Last Update Posted: 2025-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sinus lifting using densah bur in combination with activated plasma albumin gel	Densah bur in combination with activated plasma albumin gel	-

Primary Outcome Measures

Name	Time	Method
Postoperative pain	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)
Implant stability	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.
Vertical bone height gain	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	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

Trial Locations

Locations (1)

Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt