Clinical trial NCT04741594: Osseodensification and Implant Survival and Success
Official title: Alveolar Ridge Expansion by Osseodensification and Its Impact on Implant Survival and Success: A Case Series
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Missing Teeth
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2021-02-05
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Bone width (mm)
timeFrame: 2 years
Secondary outcomes:
measure: implant stability
timeFrame: 2 years
measure: Survival and failure rate
timeFrame: 2 years
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: College of Dentistry, OUHSC
state: Oklahoma
Study officials:
References: