Comparing immediate and delayed loading of maxillary overdenture implants
Immediate Versus Delayed Loading of Maxillary Overdenture Implants
NA · Case Western Reserve University · NCT06038487
This study is testing whether putting in maxillary overdenture implants right away or waiting three months affects bone loss and other outcomes for patients over three years.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Case Western Reserve University (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT06038487 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are fully edentulous individuals aged 21 and older with adequate bone for implant placement.
Not a fit: Patients with chronic conditions requiring antibiotics, prolonged steroid use, or those with bleeding disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the optimal timing for loading implants, potentially improving patient outcomes and satisfaction.
How similar studies have performed: Previous studies have shown varying success with immediate versus delayed loading of implants, but this specific approach is being evaluated for its unique outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Cleveland, Ohio
- Case Western Reserve University Department of Periodontics — Cleveland, Ohio, United States (RECRUITING)
Study contacts
- Principal investigator: Gian P Schincaglia, DDS, PhD — Case Western Reserve University
- Study coordinator: Elysha Pomerantz, DMD
- Email: emp142@case.edu
- Phone: 216-368-4412
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Implant Complication, Implant Overdenture, Immediate loading, Delayed loading, Maxillary Overdenture, Novaloc Retention System, Guided Implants, Immediate vs Delayed loading