Ridge Expansion by Osseodensification

Horizontal Ridge Deficiency Clinical Trial

Official title:

The Use of Osseodensification for Ridge Expansion and Dental Implant Placement in Narrow Alveolar Ridges: A Prospective Observational Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04748952
• Other study ID #: 19931993
• Status: Completed
• Start date: January 26, 2021
• Est. completion date: October 30, 2021

Study information

• Verified date: March 2022
• Source: University of Baghdad
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 30, 2021
• Est. primary completion date: August 1, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria

1. Healthy adult patients (= 18 years) with American Society of Anesthesiologist physical status classification level I (ASA I), of either gender, having single or multiple missing teeth in the maxilla and/or mandible with alveolar ridge width of 3-6 mm measured at the crest using CBCT.

2. Patients should have = 2 mm of trabecular bone core and = 1/1 trabecular to cortical bone ratio to achieve a predictable expansion according to manufacture instruction in ridge expansion protocol provided by Versah©.

3. Adequate vertical bone height of the alveolar ridge for placement of a minimum length of 8 mm dental implant length based on preoperative OPG or CBCT.

4. Patients who were willing to comply with the study and were available for follow-up visits.

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.

Related Conditions & MeSH terms

• Horizontal Ridge Deficiency

Intervention

Device:
• Densah burs
Osseodensification is a non-excavating implant site preparation technique. It creates a densified layer of surrounding bone through compaction autografting while simultaneously plastically expanding the bony ridge at the same time facilitating for placement of large diameter implants and also avoiding fenestration and dehiscence defects. The autografting occurs along the entire length of the osteotomy through a hydrodynamic process with the use of irrigation. The result is a consistently cylindrical and densified osteotomy.

Locations

Country	Name	City	State
Iraq	College of dentistry	Baghdad

Sponsors (1)

Lead Sponsor	Collaborator
University of Baghdad

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alveolar ridge width	Buccolingual alveolar ridge width measured by using bone caliper at the crest before and after osteotomy preparation to assess amount of expansion obtained	0 day
Secondary	Implant stability	Implant stability will be measured using resonance frequency analysis (RFA) by Osstell Beacon device.	T0= Primary implant stability measured immediately after implant installation , T1 = secondary implant stability measured after 16 weeks