Status:
COMPLETED
Immediate Loading of 4 Guided Implants Supporting a Maxillary Overdenture Using a Novaloc TiN Retention System
Lead Sponsor:
West Virginia University
Collaborating Sponsors:
Institut Straumann AG
Conditions:
Immediate Dental Implant Loading
Denture, Complete
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
Complete dentures represent the traditional dental treatment for patients without teeth. However, retention and stability of this type of denture are often lacking, so dental implants are indicated in...
Eligibility Criteria
Inclusion
- 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 a 3.75 x 10 mm 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
- 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 history of non-compliance, unreliability.
- Local exclusion criteria:
- 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 In this instance, the patient must be withdrawn and treated according to the standard protocol.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
- Inadequate bone volume for implants insertion as measured on the per-treatment CBCT.
Key Trial Info
Start Date :
January 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2023
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT06083506
Start Date
January 3 2019
End Date
May 15 2023
Last Update
July 20 2025
Active Locations (1)
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1
West Virginia University
Morgantown, West Virginia, United States, 26506