Osseodensification by Densah Burs Versus Osteotome

Not Applicable

• Conditions: Maxillary Sinus Lift
• Interventions: Procedure: oseodensification sinus lifting; Procedure: osteotome sinus lifting

• Registration Number: NCT04688957
• Lead Sponsor: Hams Hamed Abdelrahman

Brief 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.

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 Timeline

• Status Verified: 2020-12
• Study Start: 2020-12-12
• Study First Submitted: 2020-12-18
• Study First Submitted QC: 2020-12-26
• Last Update Submitted: 2020-12-26
• Study First Posted: 2020-12-30
• Last Update Posted: 2020-12-30
• Primary Completion: 2021-07-01
• Study Completion: 2021-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oseodensification sinus lifting	oseodensification sinus lifting	-
osteotome sinus lifting	osteotome sinus lifting	-

Primary Outcome Measures

Name	Time	Method
implant stability	at 6 months	Using the Osstell, The result is presented as an ISQ value of 1-100. The higher the ISQ, the more stable the implant
change in bone height	at baseline and 6 months	using CBCT
change in bone density	at baseline and 6 months	using CBCT

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt