Osseodensification and Implant Survival and Success

University of Oklahoma (OU)

Status: Completed

Conditions: Missing Teeth

Treatments: Device: Densah

Study type: Interventional

Funder types: Other

Identifiers

NCT04741594

12966

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

4. Inclusion / Exclusion Criteria

The inclusion criteria include:

1. Adult patients ≥18 years old
2. Able to understand and sign a written informed consent form and willing to fulfil all study requirements
3. Healed edentulous ridge that is planned for an implant restoration.
4. Experimental site has not been previously augmented with xenograft
5. Experimental site has at least 2 mm of cancellous bone

The exclusion criteria include:

1. Uncontrolled systemic disease
2. Currently smoking >10 cigarettes/day
3. History of head/neck radiotherapy within the past five years
4. Current use of oral bisphosphonates or history of IV bisphosphonate use
5. Pregnant, expecting to become pregnant, or lactating women
6. Presence of active periodontal disease
7. Poor oral hygiene
8. Previous history of implant failure at the site

The early termination criteria include:

1. The researcher believes that it is not in the patient's best interest to stay in the study
2. Based on the exclusion criteria, the patient becomes ineligible to participate
3. Patient's medical condition requires interventions which preclude involvement in the study (radiation therapy, chemotherapy, etc)
4. Patient does not follow study related instructions
5. The study is suspended or canceled

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Versah group

Experimental group

Treatment:

Device: Densah