Immediate Versus Delayed Loading of Maxillary Overdenture Implants

Launched by CASE WESTERN RESERVE UNIVERSITY · Sep 8, 2023

Keywords

ClinConnect Summary

This clinical trial is studying two different ways of placing dental implants for people who need a complete upper denture (overdenture). The researchers want to find out if putting in the implants right away (immediate loading) is better or worse than waiting a while before doing so (delayed loading). They will mainly look at how much bone loss occurs around the implants over a period of three years, as well as how patients feel about the treatment.

To be eligible for the trial, participants need to be at least 21 years old and must have lost all their upper teeth. They should also have enough healed bone where the implants will be placed and be currently wearing dentures that fit well. People with certain health conditions, like bleeding disorders or severe oral infections, won’t be able to participate. If you join the study, you will receive either the immediate or delayed implant treatment, and the team will closely monitor your progress and overall satisfaction over the next three years. This trial is currently looking for volunteers, and all genders are welcome to participate.

Gender

ALL

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).