Ridge Expansion by Osseodensification

NCT04748952 | Completed

• 1 other identifier: 19931993
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Horizontal Ridge Deficiency

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Implant stability

  T0= Primary implant stability measured immediately after implant installation , T1 = secondary implant stability measured after 16 weeks

Study Arms (1)

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

Interventions

Densah burs DEVICE

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.

Also known as: Osseodensification

Adult with horizontal bone defect

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy adults with missing one or more tooth with horizontal alveolar bone defect seeking for dental implant treatment

You may qualify if:

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

You may not qualify if:

• \- 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.
• \. 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.

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

College of dentistry

Baghdad, Iraq

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Bachelor of Dental Surgery (Master's student)

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: February 10, 2021
• Study Start: January 26, 2021
• Primary Completion: August 1, 2021
• Study Completion: October 30, 2021
• Last Updated: April 5, 2022

Record last verified: 2022-03

Locations

IR (1)