Ridge Expansion by Osseodensification

Completed

• Conditions: Horizontal Ridge Deficiency
• Interventions: Device: Densah burs

• Registration Number: NCT04748952
• Lead Sponsor: University of Baghdad

Brief Summary

A prospective observational clinical study guided by the guidelines of Strengthening the Reporting of Observational Studies in Epidemiology (STORBE) in 2014, that conducted to assess amount of ridge expansion obtained by using Dansah burs with simultaneous implant placement.

Detailed Description

In this study, 40 implants will be installed in osteotomy sites prepared by Densah burs (osseodensification preparation technique) for patients with horizontal bone deficiency based on radiographic findings (CBCT).

Alveolar ridge width will be measured intraoperatively before and after osteotomy site preparation to assess the amount of ridge expansion. Implant stability will be measured immediately after implant installation and 16 weeks later.

Study Timeline

• Study Start: 2021-01-26
• Study First Submitted: 2021-01-28
• Study First Submitted QC: 2021-02-08
• Study First Posted: 2021-02-10
• Primary Completion: 2021-08-01
• Study Completion: 2021-10-30
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-25
• Last Update Posted: 2022-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

• 1. Patients with high bone density (more than 850 HU which corresponds to D1 and D2 according to Misch classification(16)) are not suitable for osseodensification.

2. Patient with severe buccal plate undercut or concavity. 3. Active infection or inflammation in the implant zone. 4. Presence of any uncontrolled systemic diseases. 5. Patients with a history of radiotherapy to the head and neck.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adult with horizontal bone defect	Densah burs	30 implants will be placed in osteotomy sites prepared by osseodensification for patients with horizontal bone deficiency based on radiographic findings (CBCT). Alveolar ridge width will be measured intraoperatively before and after osteotomy site preparation to assess the amount of ridge expansion. Implant stability will be measured immediately after implant installation and 16 weeks later.

Primary Outcome Measures

Name	Time	Method
Alveolar ridge width	0 day	Buccolingual alveolar ridge width measured by using bone caliper at the crest before and after osteotomy preparation to assess amount of expansion obtained

Secondary Outcome Measures

Name	Time	Method
Implant stability	T0= Primary implant stability measured immediately after implant installation , T1 = secondary implant stability measured after 16 weeks	Implant stability will be measured using resonance frequency analysis (RFA) by Osstell Beacon device.

Trial Locations

Locations (1)

College of dentistry; 🇮🇶 Baghdad, Iraq