Zolidd One ExHex Dental Implant Compared to Uncoated One ExHex Dental Implant in Subjects With Partial Edentulism

• ClinicalTrials.gov Identifier: NCT03283241
• Recruitment Status: Unknown
• First Posted: September 14, 2017
• Last Update Posted: January 18, 2020
• Sponsor: Addbio AB
• Information provided by (Responsible Party): Addbio AB

Study Description

Brief Summary:

A randomised, multicentre, double blind, parallel group comparative investigation where subjects will be randomised to receive coated or uncoated implants

Condition or disease	Intervention/treatment	Phase
Partial Edentulism	Device: Zolidd One ExHex; Device: One ExHex	Not Applicable

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.

Part II, of the study is a post-follow up study starting when the first subject has completed visit 5. There will be a separate CSR written for Study Part II.

The study Part I will begin with a baseline visit, visit 1, Informed consent procedure will take place. Provided the subject will give informed consent for both Study Part I and Study Part II the screening procedure starts. Subjects will undergo all screening and baseline assessment procedures including assessments of dental status to determine number of implants needed. Subjects who meet all the inclusion criteria and none of the exclusion criteria will be given a date for implant surgery within three weeks. The required number of implants will be ordered from the Study Distributor.

At the implantation day, visit 2, eligibility will be re-checked before the surgery procedures starts. The subjects who still are eligible will enter the treatment and the implantation surgery is conducted. The first follow-up visit after implantation will take place week 2 post-surgery and the last follow-up visit in Study Part I will be at week 12. Any post-surgical complications and adverse events will be collected and recorded in the eCRF. On demand, depending on the outcome of the surgery, additional visits might occur.

Study Part II, the Post Follow-up Study, consist of two visits, one at month 12 and another visit at month 24 post-surgery. Post-surgical complications and adverse events from Study Part I will be followed-up if not resolved previously. Safety, survival rate and marginal bone loss will be assessed and outcome recorded in the eCRF. Additional visits might occur depending on the status of the subjects.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 71 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Parallel groups ration 1;1
• Masking: Triple (Participant, Care Provider, Investigator)
• Masking Description: The devices are delivered single packed and sterile to distributor. The distributor performs blinding, randomization and distribution. The labels are, after blinding of lot number, identical for both the Active and the placebo device.
• Primary Purpose: Treatment
• Official Title: A Randomized, Multicentre, Double Blind, Parallel Study to Evaluate the Performance and Safety of the Zolidd One ExHex Dental Implant Compared to Uncoated One ExHex Dental Implant in Subjects With Partial Edentulism
• Actual Study Start Date: September 1, 2017
• Estimated Primary Completion Date: July 30, 2020
• Estimated Study Completion Date: November 30, 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Zolidd One ExHex; Coated titanium implant	Device: Zolidd One ExHex; Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.; Device: One ExHex; Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
Sham Comparator: One ExHex; Uncoated titanium implant	Device: Zolidd One ExHex; Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.; Device: One ExHex; Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.

Outcome Measures

Primary Outcome Measures :

1. Change in stability from day 1 to 12 weeks after implantation of the "index implant" comparing coated and uncoated implants [ Time Frame: 12 weeks ]
   The primary objective is to compare the change in stability from day 1 (implantation) to 12 weeks after surgery of the "index implant" between coated and uncoated implants.

Secondary Outcome Measures :

1. Absolute ISQ highest value [ Time Frame: week 8 and week 12 ]
   To compare absolute ISQ highest values between coated and uncoated "index implants" at week 8 and week 12 after implantation
2. Incidence of post-surgery complications and adverse events [ Time Frame: Day1 to week 12 ]
   To compare safety as assessed by complications post-surgery and any other adverse event up to week 12 between all coated and all uncoated implants
3. Change in ISQ highest value for the "index implant" [ Time Frame: Day 1 to week 8 ]
   To compare change in stability from day 1 to week 8 between the coated and the uncoated "index implants"
4. Change in ISQ highest value for all other implants [ Time Frame: Day 1, week 8 and week 12 ]
   To compare change in stability day 1 to week 8 and 12 between all other coated and all other uncoated implants
5. Absolute ISQ highest value for all other implants [ Time Frame: Week 8 and 12 ]
   To compare absolute ISQ highest value at week 8 and 12 between all other coated and all other uncoated implants
6. Change in marginal bone height for all other implants [ Time Frame: Day 1 to week 8 and 12 ]
   To compare change in marginal bone height between all coated and all uncoated implants from day 1 to week 8 and 12
7. Post-surgical complications and other adverse events for all implants [ Time Frame: week 12 to month 24 ]
   To compare safety as assessed by complications post-surgery and other adverse events up to month 24 post-implantation visit between all coated and all uncoated implants
8. Survival rate for all implants [ Time Frame: 24 months ]
   To compare survival rate of implants up to 24 months between all coated and all uncoated implants
9. Change in marginal bone height for all implants [ Time Frame: Day 1, month 12 and 24 ]
   To compare change in marginal bone height from day 1 to month 12 and 24 between all coated and all uncoated implants
10. Occurrence of signs associated with peri-implantitis for all implants [ Time Frame: Month 12 and 24 ]
    To compare peri-implantitis frequency at 12 and 24 months between all coated and all uncoated implants

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Sweden

Dingletandläkarna

Dingle, Sweden, 45561

Praktikertjänst AB Holmgatans Tandläkarmottagning

Falun, Sweden, 79171

Käk-kirurgiska Kliniken, Näl

Trollhättan, Sweden, 46185

Sponsors and Collaborators

Addbio AB

Investigators

• Principal Investigator: Christer Dahlin, DDS, PhD; Käk kirurgiska kliniken NÄL, Trollhättan, Sweden

More Information

• Responsible Party: Addbio AB
• ClinicalTrials.gov Identifier: NCT03283241
• Other Study ID Numbers: ADD-001
• First Posted: September 14, 2017
• Last Update Posted: January 18, 2020
• Last Verified: January 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Not planned at the moment

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No