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Ridge Expansion by Osseodensification

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04748952
Enrollment
40
Registered
2021-02-10
Start date
2021-01-26
Completion date
2021-10-30
Last updated
2022-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Horizontal Ridge Deficiency

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.

Interventions

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.

Sponsors

University of Baghdad
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frameDescription
Alveolar ridge width0 dayBuccolingual alveolar ridge width measured by using bone caliper at the crest before and after osteotomy preparation to assess amount of expansion obtained

Secondary

MeasureTime frameDescription
Implant stabilityT0= Primary implant stability measured immediately after implant installation , T1 = secondary implant stability measured after 16 weeksImplant stability will be measured using resonance frequency analysis (RFA) by Osstell Beacon device.

Countries

Iraq

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026