Osseodensification by Densah Burs Versus Osteotome

Maxillary Sinus Lift Clinical Trial

Official title:

Osseodensification by Densah Burs Versus Osteotome for Transcrestal Maxillary Sinus Lifting With Simultaneous Implant Placement (Randomized Clinical Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04688957
• Other study ID #: osseodensifcation
• Status: Recruiting
• Phase: N/A
• Start date: December 12, 2020
• Est. completion date: August 1, 2021

Study information

• Verified date: December 2020
• Source: Alexandria University
• Contact: Mohammed T Elghobashy, BDS
• Phone: 011121158436
• Email: abotalaat20112371993[@]gmil.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

implant placement in the posterior maxilla is problematic, not only due to inferior properties of bone but also due to loss of vertical bone height which happens after extraction of posterior teeth. when the required additional height is few millimeters, indirect transcresta sinus lifting procedures are recommended.

This study compares sinus lifting using the conventional osteotome versus the osseodensification with densah burs.

Description:

a total of 12 patients with missing maxillary premolars or molars and with limited vertical bone height below the maxillary sinus floor will receive implants either with osteotome or with Densah burs transcrestal sinus lifting to compare clinically and radiographically transcrestal sinus lifting with Densah burs and osteotome with simultaneous implant placement

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: August 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• Patient with missing maxillary premolas and molars

• Vertical bone height of 5-8 mm

• Non smokers

• Good oral hygiene

Exclusion Criteria:

• Bad oral hygiene

• maxillary sinusitis

• Presence of infection or periapical lesions in adjacent teeth

• Bruxism or clenching

• Alcoholism

• Medically compromised patients with a condition that affect the procedure

• Multiple sinus septa

Related Conditions & MeSH terms

• Maxillary Sinus Lift

Intervention

Procedure:
• oseodensification sinus lifting
application of first densah bur with densifying mood (reverse) counterclockwise, 1200 revolution per minute until the sinus is reached then use a wider densah bur with the same mode and bouncing motion to elevate the sinus floor up to 3 mm in 1mm increments.
• osteotome sinus lifting
drilling implant site with consecutive drills short of the sinus floor by 1-2mm , using osteotome in appropriate size and application of one tap until sinus floor is elevated, using the final drill for the desired implant diameter

Locations

Country	Name	City	State
Egypt	Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Hams Hamed Abdelrahman

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	implant stability	Using the Osstell, The result is presented as an ISQ value of 1-100. The higher the ISQ, the more stable the implant	at 6 months
Primary	change in bone height	using CBCT	at baseline and 6 months
Primary	change in bone density	using CBCT	at baseline and 6 months
Secondary	Pain scores	10-point Visual Analogue Scale (VAS). (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe)	at 2 weeks
Secondary	edema scores	The pitting is graded on a scale of +1 to +4 as follows: +1 (trace) slight indentation rapid return to normal.; +2 (mild) the indentation returns to normal in a few seconds.; +3 (moderate) 6 mm indentation rebounds in 10-20 seconds.; +4 (severe) 8 mm indentation rebounds in more than 30 seconds.	at 2 weeks