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Immediate Versus Delayed Loading of Maxillary Overdenture Implants

Case Western Reserve University · with Institut Straumann AG · NCT06038487

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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
Immediate Versus Delayed Loading of Maxillary Overdenture Implants (NCT06038487) | Bored Studies