Ridge Expansion by Osseodensification

Sponsor
University of Baghdad (Other)
Overall Status
Completed
CT.gov ID
NCT04748952
Collaborator
(none)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Densah burs

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 Design

Study Type:
Observational
Actual Enrollment :
40 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
The Use of Osseodensification for Ridge Expansion and Dental Implant Placement in Narrow Alveolar Ridges: A Prospective Observational Clinical Study
Actual Study Start Date :
Jan 26, 2021
Actual Primary Completion Date :
Aug 1, 2021
Actual Study Completion Date :
Oct 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Adult with horizontal bone defect

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.

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.
Other Names:
  • Osseodensification
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All

    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.
    1. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 College of dentistry Baghdad Iraq

    Sponsors and Collaborators

    • University of Baghdad

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rosol Dawod Salman, Bachelor of Dental Surgery (Master's student), University of Baghdad
    ClinicalTrials.gov Identifier:
    NCT04748952
    Other Study ID Numbers:
    • 19931993
    First Posted:
    Feb 10, 2021
    Last Update Posted:
    Apr 5, 2022
    Last Verified:
    Mar 1, 2022

    Study Results

    No Results Posted as of Apr 5, 2022