Osseodensification by Densah Burs Versus Osteotome

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

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.

Study Overview

• Status: Unknown
• Conditions: Maxillary Sinus Lift
• Intervention / Treatment: Procedure: osteotome sinus lifting; Procedure: oseodensification sinus lifting

Detailed 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

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Recruiting
    • Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University
    • Contact: Mohammed T Elghobashy, BDS; Phone Number: 002 01112158436; Email: abotalaat20112371993@gmail.com
    • Principal Investigator: Mohammed T Elghobashy, BDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: osteotome sinus lifting	Procedure: 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
Experimental: oseodensification sinus lifting	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
change in bone height	using CBCT	at baseline and 6 months
change in bone density	using CBCT	at baseline and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scores	10-point Visual Analogue Scale (VAS). (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe)	at 2 weeks
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

Collaborators and Investigators

• Sponsor: Hams Hamed Abdelrahman

Publications and helpful links

General Publications

• Elghobashy MTM, Shaaban AM, Melek LNF. Radiographic comparison between Densah burs and osteotome for graftless internal sinus lifting with simultaneous implant placement: a randomized clinical trial. Int J Oral Maxillofac Surg. 2022 Jul 12. pii: S0901-5027(22)00286-7. doi: 10.1016/j.ijom.2022.06.020. [Epub ahead of print]

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2020
• Primary Completion (Anticipated): July 1, 2021
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: December 18, 2020
• First Submitted That Met QC Criteria: December 26, 2020
• First Posted (Actual): December 30, 2020

Study Record Updates

• Last Update Posted (Actual): December 30, 2020
• Last Update Submitted That Met QC Criteria: December 26, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: osseodensifcation

Drug and device information, study documents

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