Implant Primary Stability and Ridge Dimensional Changes Utilizing the Osseodensification Protocol

Dental Implants Clinical Trial

Official title:

Implant Primary Stability and Ridge Dimensional Changes Utilizing the Osseodensification Protocol

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05283928
• Other study ID #: HSC-DB-21-0597
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: May 28, 2024

Study information

• Verified date: May 2024
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare ridge dimensional changes between densification and standard drilling protocols and to compare primary and secondary stability of implants placed by bone densification and standard drilling protocols

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: May 28, 2024
• Est. primary completion date: May 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

• Patients who understand and agree to this study.

• Adequate Oral hygiene

• One or more edentulous spaces, which are 10 weeks or longer after extractions

Exclusion Criteria:

• Pregnancy.

• Smoking of more than 5 cigarettes/day.

• History of alcoholism or drug abuse during the last 5 years.

• Uncontrolled Hypertension or diabetes.

• Patient with malignant tumor.

• Patients on daily dose of steroids.

• Patients with history of chemotherapy or radiation for the last 12 months.

Related Conditions & MeSH terms

• Dental Implants

Intervention

Device:
• OsseoDensification (OD) protocol
Osseodensification is a drilling process by which bone is being compacted and auto-grafted in an outwardly expanding direction from the osteotomy. When the osseodensification drills are being rotated in a reversed, non-cutting direction a strong and dense layer of bone is formed along the walls and base of the osteotomy.
• standard drilling (SD) protocol (NobelReplace® Conical)
osteotomy preparation through bone excavation is necessary in implant site development for the placement of dental implants. The process involves a forward cutting process with removal of bone tissue creating appropriate size osteotomy for the dental implant.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in bone ridge width at crest	bone ridge width will be measured using a Mitutoyo Digimatic Caliper	day of implant surgery
Primary	Change in bone ridge width at 5mm apical from crest	bone ridge width will be measured using a Mitutoyo Digimatic Caliper	day of implant surgery
Primary	Change in bone ridge width at 10mm apical from crest	bone ridge width will be measured using a Mitutoyo Digimatic Caliper	day of implant surgery
Secondary	Primary stability of the implants as measured by the insertion torque values		day of implant surgery
Secondary	Change in primary stability of the implants as indicated by the implant stability quotient (ISQ) as measured by the resonance frequency analysis using the Ostell ISQ meter		baseline(after implant placement),3 weeks after implant placement and 6 weeks after implant placement
Secondary	volume of the ridge as assessed by the Cone beam computer tomography (CBCT)		6 months post implantation
Secondary	buccolingual width of the ridge as assessed by the Cone beam computer tomography (CBCT)		6 months post implantation