Actively Recruiting

Phase Not Applicable
Age: 21Years +
All Genders
Healthy Volunteers
NCT06038487

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

Age: 21Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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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

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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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Immediate Versus Delayed Loading of Maxillary Overdenture Implants | DecenTrialz