Comparing immediate and delayed loading of maxillary overdenture implants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the outcomes of maxillary overdentures supported by implants that are either immediately loaded or loaded after a delay of three months. It focuses on measuring radiographic bone loss over a period of 36 months, with assessments at 6, 12, 24, and 36 months post-loading. Secondary objectives include examining the condition of the peri-implant mucosa, implant survival rates, and patient-centered outcomes. Participants will undergo a thorough evaluation to ensure they meet the inclusion criteria before being assigned to one of the two loading approaches.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Males and females must be at least ≥ 21 years of age
2. Fully edentulous maxilla
3. The implant site has to be healed for at least 4 months after extraction
4. Wearing complete dentures deemed adequate
5. Orthopantomogram available (OPT)
6. Adequate amount of bone at least at the 2nd premolar position to house at minimum a 3.5 x 10 mm BLX-Roxolid implant
7. No bone grafting required
8. Implant IT ≥ 20 N/cm

Exclusion Criteria:

1. Conditions requiring chronic routine prophylactic use of antibiotics
2. Conditions requiring prolonged use of steroids
3. History of leukocyte dysfunction and deficiencies
4. Bleeding disorders
5. History of neoplastic disease requiring use of radiation or chemotherapy
6. Metabolic bone disorders
7. Uncontrolled endocrine disorder
8. Use of any investigational drug or device within the 30-day period prior to implant surgery
9. Vaping, Tobacco Chewing or Smoking more than 10 cigarettes a day
10. Alcoholism or drug abuse
11. Patient infected with HIV
12. 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.
13. Local inflammation including untreated periodontitis
14. Mucosal disease such as erosive lichen planus
15. History of local irradiation therapy
16. Osseous lesion
17. Severe bruxism and clenching habits
18. Active infection with suppuration or fistula track
19. Persistent intraoral infection
20. Lack of primary stability \<20Ncm. In this instance, the patient must be withdrawn and treated according to the standard protocol.
21. Inadequate oral hygiene or unmotivated home care.
22. Bone grafting needed
23. Inadequate bone volume for implants insertion as measured on the pre-treatment cone beam computed tomography (CBCT).

Where it's running

• Case Western Reserve University Department of Periodontics
  Cleveland, Ohio, United States Recruiting
• West Virginia University
  Morgantown, West Virginia, United States Recruiting

Study contacts

• Principal investigator: Gian P Schincaglia, DDS, PhD — Case Western Reserve University
• Study coordinator: Gian P Schincaglia, DDS, PhD
• Email: emp142@case.edu
• Phone: 216-368-4412

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.