Actively Recruiting
Immediate Versus Delayed Loading of Maxillary Overdenture Implants A Randomized Study Comparing Bone Loss and Outcomes Over 36 Months
Led by Case Western Reserve University · Updated on 2026-05-20
18
Participants Needed
1
Research Sites
52 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
Researchers are studying implant-retained maxillary complete dentures to compare immediate loading versus delayed loading approaches. The study focuses on the bone loss around dental implants in the upper jaw over a period of 36 months. The goal is to understand differences in radiographic, clinical, and patient-centered outcomes between these two methods. Participants will receive BLX Roxolid implants placed using flapless guided surgery. One group will have their maxillary denture immediately connected to the implants during surgery, with the abutment screw tightened to 15 Ncm and the denture secured using a special resin. The other group will have implants covered and healed under the gum for 3 months before connecting the denture, with the abutment screw tightened to 35 Ncm at that time. Both groups will follow specific care instructions post-surgery, including rinsing and diet recommendations. Participants will be monitored through multiple visits at 1, 2, 4, 12 weeks, and 6, 12, 24, and 36 months after surgery. Evaluations include radiographic bone level changes, gum health, implant survival, complications, and patient satisfaction through questionnaires. Radiographs will be taken at several time points using specialized film holders to ensure consistency. All complications and patient complaints will be recorded and followed. The study lasts for 36 months with ongoing assessments.
CONDITIONS
Brief Title
Immediate Versus Delayed Loading of Maxillary Overdenture Implants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females must be at least �3e�3d 21 years of age
- Fully edentulous maxilla (upper jaw without teeth)
- Implant site healed for at least 4 months after extraction
- Wearing complete dentures deemed adequate
- Orthopantomogram (OPT) available
- Adequate bone at least at the 2nd premolar position to fit a 3.5 x 10 mm BLX-Roxolid implant
- No bone grafting required
- Implant insertion torque (IT) �3e�3d 20 N/cm
You will not qualify if you...
- Conditions requiring chronic routine prophylactic use of antibiotics
- Conditions requiring prolonged use of steroids
- History of leukocyte dysfunction and deficiencies
- Bleeding disorders
- History of cancer requiring radiation or chemotherapy
- Metabolic bone disorders
- Uncontrolled endocrine disorders
- Use of any investigational drug or device within 30 days prior to implant surgery
- Vaping, tobacco chewing, or smoking more than 10 cigarettes a day
- Alcoholism or drug abuse
- HIV infection
- Conditions preventing study completion or interfering with results, including history of non-compliance
- Local inflammation including untreated periodontitis
- Mucosal disease such as erosive lichen planus
- History of local irradiation therapy
- Bone lesions
- Severe bruxism or clenching habits
- Active infection with pus or fistula
- Persistent intraoral infection
- Lack of primary stability (insertion torque less than 20 Ncm)
- Inadequate oral hygiene or unmotivated home care
- Bone grafting needed
- Inadequate bone volume for implant insertion as measured on pre-treatment CT scan
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo implant placement surgery using a flapless guided procedure under local anesthesia. After implant placement, they are randomly assigned to immediate or delayed loading groups.
1 visit (in-person)
Duration - Up to 3 months
Participants receive either immediate loading where the denture is connected to the implants on the day of surgery or delayed loading where implants heal submerged for 3 months before connecting the denture.
Weekly visits for up to 12 weeks
Duration - 36 months
Participants are monitored for implant stability, prosthetic maintenance, and healing with repeated clinical and radiographic assessments up to 36 months after implant placement.
Visits at 1, 2, 4, 12 weeks and 6, 12, 24, and 36 months post-surgery
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
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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