Actively Recruiting
Immediate Versus Delayed Loading of Maxillary Overdenture Implants
Led by Case Western Reserve University · Updated on 2025-02-28
18
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
Sponsors
C
Case Western Reserve University
Lead Sponsor
I
Institut Straumann AG
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 approach by primarily evaluating radiographic bone loss of dental implants placed in the maxilla over 36 months
CONDITIONS
Official Title
Immediate Versus Delayed Loading of Maxillary Overdenture Implants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females at least 21 years old
- Fully edentulous maxilla
- Implant site healed at least 4 months after extraction
- Wearing complete dentures deemed adequate
- Available orthopantomogram (OPT)
- Adequate bone at 2nd premolar position for 3.5 x 10 mm BLX-Roxolid implant
- No bone grafting required
- Implant insertion torque 20 N/cm or greater
You will not qualify if you...
- Conditions requiring chronic routine prophylactic antibiotics
- Prolonged steroid use
- History of leukocyte dysfunction or deficiencies
- Bleeding disorders
- History of cancer treatment with radiation or chemotherapy
- Metabolic bone disorders
- Uncontrolled endocrine disorders
- Use of investigational drug/device within 30 days before surgery
- Smoking, vaping, or chewing tobacco more than 10 cigarettes per day
- Alcoholism or drug abuse
- HIV infection
- Conditions preventing study completion or reliable results (e.g., non-compliance)
- Local inflammation or untreated periodontitis
- Mucosal diseases like erosive lichen planus
- History of local radiation therapy
- Bone lesions
- Severe teeth grinding or clenching habits
- Active infections with pus or fistula
- Persistent oral infection
- Lack of primary implant stability (insertion torque below 20 Ncm)
- Poor oral hygiene or lack of motivation for home care
- Need for bone grafting
- Inadequate bone volume for implant insertion on CBCT
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Case Western Reserve University Department of Periodontics
Cleveland, Ohio, United States, 44106
Actively Recruiting
Research Team
E
Elysha Pomerantz, DMD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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