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Immediate Versus Delayed Loading of Maxillary Overdenture Implants
RecruitingHealthy volunteers welcome
Who can join
Ages 21 and older · All sexes · Healthy volunteers welcome
Full eligibility 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 In this instance, the patient must be withdrawn and treated according to the standard protocol. 21.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).
About the study
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
What is being tested
- Immediate loading of maxillary implant overdenture (procedure)
- Delayed loading of maxillary implant overdenture (procedure)
Sponsor: Case Western Reserve University · Participants: 18 · Started: Feb 1, 2023
Contact the study team
- Gian P Schincaglia, DDS, PhD · Phone: 216-368-4412
Official record on ClinicalTrials.gov — NCT06038487
Locations in the U.S.
| Ohio | Case Western Reserve University Department of Periodontics, Cleveland |
| West Virginia | West Virginia University, Morgantown |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.