Status:
RECRUITING
Immediate Versus Delayed Loading of Maxillary Overdenture Implants
Lead Sponsor:
Case Western Reserve University
Collaborating Sponsors:
Institut Straumann AG
Conditions:
Implant Complication
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
The purpose of the study is to evaluate the radiographic, clinical and patient-centered outcomes of implant-retained immediately-loaded maxillary complete dentures in comparison to delayed loading app...
Detailed Description
The primary objective of this study is to evaluate radiographically at 6, 12, 24, and 36 months post-loading the performance of the BLX Roxolid™ implants placed using a flapless guided surgery and imm...
Eligibility Criteria
Inclusion
- Males and females must be at least ≥ 21 years of age
- Fully edentulous maxilla
- The implant site has to be healed for at least 4 months after extraction
- Wearing complete dentures deemed adequate
- Orthopantomogram available (OPT)
- Adequate amount of bone at least at the 2nd premolar position to house at minimum a 3.5 x 10 mm BLX-Roxolid implant
- No bone grafting required
- Implant IT ≥ 20 N/cm
Exclusion
- Conditions requiring chronic routine prophylactic use of antibiotics
- Conditions requiring prolonged use of steroids
- History of leukocyte dysfunction and deficiencies
- Bleeding disorders
- History of neoplastic disease requiring use of radiation or chemotherapy
- Metabolic bone disorders
- Uncontrolled endocrine disorder
- Use of any investigational drug or device within the 30-day period prior to implant surgery
- Vaping, Tobacco Chewing or Smoking more than 10 cigarettes a day
- Alcoholism or drug abuse
- Patient infected with HIV
- Condition or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as as history of non-compliance, unreliability.
- Local inflammation including untreated periodontitis
- Mucosal disease such as erosive lichen planus
- History of local irradiation therapy
- Osseous lesion
- Severe bruxism and clenching habits
- Active infection with suppuration or fistula track
- Persistent intraoral infection
- Lack of primary stability \<20Ncm. In this instance, the patient must be withdrawn and treated according to the standard protocol.
- Inadequate oral hygiene or unmotivated home care.
- Bone grafting needed
- Inadequate bone volume for implants insertion as measured on the pre-treatment cone beam computed tomography (CBCT).
Key Trial Info
Start Date :
February 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT06038487
Start Date
February 1 2023
End Date
February 1 2028
Last Update
February 28 2025
Active Locations (1)
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1
Case Western Reserve University Department of Periodontics
Cleveland, Ohio, United States, 44106