๐ฌIn plain words
What the trial is, and whether it could suit you
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
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
1. Males and females must be at least โฅ 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 โฅ 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 In this instance, the patient must be withdrawn and treated according to the standard protocol.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).