Immediate Versus Delayed Loading of Maxillary Overdenture Implants
Case Western Reserve University · with Institut Straumann AG · NCT06038487
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 21+ · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 18
- US sites recruiting
- 2
- Study start
- February 1, 2023
- Record last updated
- September 15, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study 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
Being studied: Immediate loading of maxillary implant overdenture; Delayed loading of maxillary implant overdenture
Conditions: Implant Complication
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- 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 Criteria
- 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).
Recruiting US locations
Case Western Reserve University Department of Periodontics
Cleveland, OH 44106
Site contact: Gian Pietro Schincaglia, DDS, PhD · 216-368-4412 · gxs486@case.edu
West Virginia University
Morgantown, WV 26505
Site contact: Arif Salman, MDS · 304-293-5831 · arif.salman@mail.wvu.edu
Study contacts (from the official record)
- Gian P Schincaglia, DDS, PhD · 216-368-4412 · emp142@case.edu
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