Osseodensification and Implant Survival and Success

Not Applicable

Completed

• Conditions: Missing Teeth
• Interventions: Device: Densah

• Registration Number: NCT04741594
• Lead Sponsor: University of Oklahoma

Brief Summary

Approximately 40 implants from patients seeking treatment at the University of Oklahoma, College of Dentistry will be recruited for this study. Osteotomies will be prepared using the osseodensification technique and implants will be placed immediately after. The implants will be from a single manufacturer (Roxolid® SLA® Bone Level Tapered; Straumann®, Institut Straumann AG, Basel, Switzerland). Volumetric analysis of alveolar ridge will be studied using intra-surgical direct measurements and CBCT imaging. A custom stent will be fabricated to standardize the clinical and radiographic measurements at 2mm, 3mm, and 4mm apical to the alveolar crest. Changes in peri-implant bone density will be analyzed on standardized periapical and bitewing radiographs, using the ImageJ software (National Institute of Health, Bethesda, Maryland, USA). Implant stability quotient (ISQ) values will be recorded with a resonance frequency analysis system (Osstell®, Gothenburg, Sweden). Calibrated examiners will assess implant survival and biological or restorative complications and failures. Sites will be evaluated throughout osseointegration and one year after final restoration is delivered.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-15
• Study First Submitted QC: 2021-02-02
• Study First Posted: 2021-02-05
• Study Start: 2021-07-01
• Primary Completion: 2022-02-21
• Study Completion: 2023-09-13
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-28
• Last Update Posted: 2024-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Versah group	Densah	-

Primary Outcome Measures

Name	Time	Method
Bone width (mm)	2 years	Bone width at 2, 3, 4 mm apical to edentulous alveolar ridge.

Secondary Outcome Measures

Name	Time	Method
implant stability	2 years	Implant stability quotient (ISQ) values
Survival and failure rate	2 years	Rates of survival and failure rate

Trial Locations

Locations (1)

College of Dentistry, OUHSC; 🇺🇸 Oklahoma City, Oklahoma, United States