Status:
COMPLETED
Zolidd One ExHex Dental Implant Compared to Uncoated One ExHex Dental Implant in Subjects With Partial Edentulism
Lead Sponsor:
Addbio AB
Conditions:
Partial Edentulism
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A randomised, multicentre, double blind, parallel group comparative investigation where subjects will be randomised to receive coated or uncoated implants
Detailed Description
The study will consist of two parts. Part I, is the main study ending when all subjects have reached visit 5. The study will be evaluated and Clinical Study Report (CSR) will be written for this part....
Eligibility Criteria
Inclusion
- Male or female subjects aged \>18 years
- Subjects should be willing to take part, able to understand the information given to them, and give written consent
- Subject diagnosed with partial edentulism and who needs at least one dental implant in the posterior upper jaw i.e. premolars to first molar. The same subject may also need implants in the posterior mandible (premolars to first molar region)
Exclusion
- Suspected to be immunocompromised or are taking immunosuppressant
- Current participation in another clinical investigation or participation within the last 6 months
- Known sensitivity/allergies to any of the test materials or any of their ingredients, such as bisphosphonate, titanium or human fibrinogen
- Significant current or past medical history of hepatic, renal, cardiac, pulmonary, digestive, haematological, neurological, or psychiatric disease, hypercalcaemia, previous or ongoing malignancy in the head and neck region or uncontrolled diabetes type I which in the opinion of the Investigator, would compromise the safety of the subject or affect the outcome of the investigation
- Pregnant and lactating females or those actively seeking to become pregnant in the next 3 months
- Previous (last 5 years) or on-going Bisphosphonate or Denosumab treatment
- Significant marginal bone loss prior to implant insertion requiring bone grafting or bone graft substitute
- Subject with extraction(s) performed in the position of implant placement within the last 2 months
- Subject with need of \>6 implants or a full bridge
- The final prosthetic construction in need of support from neighbouring teeth
- Known drug or alcohol abuse
- Subjects only needed implant(s) in the posterior mandible region
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2020
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT03283241
Start Date
September 1 2017
End Date
October 1 2020
Last Update
March 22 2022
Active Locations (3)
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1
Dingletandläkarna
Dingle, Sweden, 45561
2
Praktikertjänst AB Holmgatans Tandläkarmottagning
Falun, Sweden, 79171
3
Käk-kirurgiska Kliniken, Näl
Trollhättan, Sweden, 46185