Implant Primary Stability and Ridge Dimensional Changes Utilizing the Osseodensification Protocol

Sponsor

The University of Texas Health Science Center, Houston (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05283928

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Dental Implants	Device: OsseoDensification (OD) protocol Device: standard drilling (SD) protocol (NobelReplace® Conical)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Implant Primary Stability and Ridge Dimensional Changes Utilizing the Osseodensification Protocol

Anticipated Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

Apr 30, 2023

Anticipated Study Completion Date :

Sep 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: OsseoDensification (OD) protocol	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.
Active Comparator: standard drilling (SD) protocol	Device: 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.

Arm

Intervention/Treatment

Experimental: OsseoDensification (OD) protocol

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.

Active Comparator: standard drilling (SD) protocol

Device: 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.

Outcome Measures

Primary Outcome Measures

Change in bone ridge width at crest [day of implant surgery]
bone ridge width will be measured using a Mitutoyo Digimatic Caliper
Change in bone ridge width at 5mm apical from crest [day of implant surgery]
bone ridge width will be measured using a Mitutoyo Digimatic Caliper
Change in bone ridge width at 10mm apical from crest [day of implant surgery]
bone ridge width will be measured using a Mitutoyo Digimatic Caliper

Secondary Outcome Measures

Primary stability of the implants as measured by the insertion torque values [day of implant surgery]
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]
volume of the ridge as assessed by the Cone beam computer tomography (CBCT) [6 months post implantation]
buccolingual width of the ridge as assessed by the Cone beam computer tomography (CBCT) [6 months post implantation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

22 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Texas Health Science Center at Houston	Houston	Texas	United States	77030

Sponsors and Collaborators

The University of Texas Health Science Center, Houston

Investigators

Principal Investigator: Popi Stylianou, DDS,MS, The University of Texas Health Science Center, Houston

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Popi Stylianou, Clinical Associate Professor, The University of Texas Health Science Center, Houston

ClinicalTrials.gov Identifier:

NCT05283928

Other Study ID Numbers:

HSC-DB-21-0597

First Posted:

Mar 17, 2022

Last Update Posted:

Mar 17, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by Popi Stylianou, Clinical Associate Professor, The University of Texas Health Science Center, Houston

osseodensification

ridge expansion

Study Results

No Results Posted as of Mar 17, 2022