N/A
N=62
Zolidd One ExHex Dental Implant Compared to Uncoated One ExHex Dental Implant in Subjects With Partial Edentulism
Partial Edentulism
Bottom Line
View on ClinicalTrials.gov: NCT03283241 ↗Enrolled (actual)
62
Serious AEs
3.2%
Results posted
Mar 2022
Primary outcome: Primary: Change in Stability at 12 Weeks Minus Value at Baseline (Day 1) Comparing Coated and Uncoated Implants Change in Stability From Day 1(Implantation to 12 Weeks After Implantation of the "Index Implant" Comparing Coated and Uncoated Implants — 7.47; 2.83 ISQ (Implant Stability Quotient) score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Zolidd One ExHex (Device); One ExHex (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Addbio AB
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Stability at 12 Weeks Minus Value at Baseline (Day 1) Comparing Coated and Uncoated Implants Change in Stability From Day 1(Implantation to 12 Weeks After Implantation of the "Index Implant" Comparing Coated and Uncoated Implants |
7.47; 2.83 | — |
| SECONDARY To Compare Absolute ISQ (Implant Stability Quotient) Highest Values Between Coated and Uncoated Implants for the "Index Implant" at Week 8 and Week 12 |
83; 85; 84; 85 | — |
| SECONDARY Incidence of Post-surgery Complications and Adverse Events |
5; 4 | — |
| SECONDARY Change in ISQ (Implant Stability Quotient) Highest Value for the "Index Implant" |
4.34; 1.38 | — |
| SECONDARY Change in ISQ Highest Value for All Other Implants |
9.0; 5.1; 7.1; 3.7 | — |
| SECONDARY Absolute ISQ (Implant Stability Quotient) Highest Value for All Other Implants |
83; 85; 84; 85 | — |
| SECONDARY Change in Marginal Bone Height for All Other Implants |
0.3; 0.2; 0.4; 0.2; 0.5; 0.4 | — |
| SECONDARY Post-surgical Complications and Other Adverse Events (AEs) for All Implants |
4; 1 | — |
| SECONDARY Survival Rate for All Implants |
0.930; 0.939 | — |
| SECONDARY Change in Marginal Bone Height for All Implants |
0.5; 0.3; 0.5; 0.3; 0.5; 0.5 | — |
| SECONDARY Occurrence of Signs Associated With Peri-implantitis for All Implants |
0; 0; 0; 0 | — |
Summary
A randomised, multicentre, double blind, parallel group comparative investigation where subjects will be randomised to receive coated or uncoated implants
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03283241). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.