Immediate Versus Delayed Loading of Maxillary Overdenture Implants

Recruiting now · Not applicable

Conditions studied: Implant Complication

In brief

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

Key facts

Study ID

NCT06038487

Run by

Case Western Reserve University

People needed

18

Starts

2023-02-01

Expected to finish

2028-02-01

Last updated by the study team

2026-05-20

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 In this instance, the patient must be withdrawn and treated according to the standard protocol.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).

Where it is running

• Case Western Reserve University Department of Periodontics — Cleveland, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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