Partly Edentulous Maxilla Clinical Trial
— XiCCOfficial title:
A Randomized, Prospective, International, Multi-center Clinical Study to Evaluate the Peri-implant Tissue Outcome of Abutment-supported XiVE® CAD/CAM Supra-structures and Directly Implant-supported XiVE® CAD/CAM Supra-structures (Split-mouth) in Partly Edentulous Human Subjects.
| Verified date | August 2022 |
| Source | Dentsply Implants Manufacturing GmbH |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study has been designed in order to collect data with regards to the peri-implant tissue outcome of abutment-supported restoration and direct implant-fixed restoration. Therefore a small group of subjects with partly edentulous maxilla is selected to show that both techniques are efficient and safe and to show comparable peri-implant tissue outcome for both methods. At the time of impression forming for each centre treatment A (= abutment-supported XiVE® CAD/CAM supra-structure) and B (= direct implant-fixed XiVE® CAD/CAM supra-structure) is assigned to the left and right side of the maxilla by being randomized at the time of impression forming.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | August 8, 2017 |
| Est. primary completion date | August 8, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: 1. Subject > 18 years. 2. Female subject of child-bearing potential must use reliable methods of contraception. 3. Subject has partly edentulous maxilla (free-end or large gap in posterior area on both sides). 4. For all implants immobility and clear percussion sound is applicable. 5. The subject is healthy and compliant with good oral hygiene. 6. Favorable and stable occlusal relationship between the remaining teeth. 7. Subject must be reliable, cooperative, and in the opinion of the Investigator, likely to be compliant with study procedures. 8. Subject provides written informed consent signed and dated prior to entering the study. 9. Implantation of XiVE® implants at least 3 months ago. 10. XiVE® implants have been placed primary stable by considering sufficient horizontal and vertical bone dimension. Exclusion Criteria: 1. Subject has a history of drug abuse, addiction to medication or alcohol abuse within the previous year. 2. Subject with planned or performed head and neck radiation. 3. Known unavailability of subject for FU Visit(s). 4. Subject has - in the opinion of the investigator - any systemic metabolic disorder or bone disorder or is taking medication that compromises or might have compromised post-operative tissue regeneration or osseointegration. 5. Subject has major bone defects in the implantation area. 6. Subject is taking medication that compromises or might have compromised post-operative healing and/or osseointegration (e. g. bisphosphonates). 7. Subject exhibits an oral infection. 8. Subject has received any investigational drug within 30 days prior to screening. 9. Severe bruxing. 10. Subject has a clinically significant or unstable medical or physiological condition. 11. Female subject is pregnant or lactating or intends to become pregnant during the course of the study. 12. Subject is not willing to participate in the study or not able to understand the content of the study. |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | University of Birmingham, School of dentistry | Birmingham |
| Lead Sponsor | Collaborator |
|---|---|
| Dentsply Implants Manufacturing GmbH |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mean Change of Bone Level | Intra-oral radiographs from implant insertion and at time for prosthesis insertion as well as from 1 and 2-year follow-up visits (calculated from the time of loading) should be taken for evaluation of bone level. All radiographs will be examined by an independent dentist.
For the purpose of this examination XCP film holder (DENTSPLY Rinn, 1212 Abbott Drive, Elgin, Illinois 60123-1819, USA) are individualized for each subject and for each x-ray. |
0, 12, 24 months | |
| Secondary | Sulcus-fluid-flow-rate | The evaluation of the sulcus fluid flow rate (SFFR) is a common method for the objective definition of the gingiva inflammation level in clinical research. The SFFR is measured with an electronic sulcus fluid hygrometer, and always as the first procedure in order not to be influenced by other investigation parameters.
The hydrometer values results are generally classified in the categories healthy (0-20), slightly irritated (21-40), moderately irritated (< 100) and strongly inflamed (> 100). For this clinical investigation no absolute values, but relative values were compared. The SFFR values measured for each implant at Visit 1 were defined as "zero point-values". The respective first natural tooth in mesial direction served as control. All values obtained at the following visits for each implant were compared to the appropriate reference value (zero point). |
6 weeks, 6, 12, 24 months |