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

NCT03283241 | Completed Results

• 1 other identifier: ADD-001
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Partial Edentulism

Outcome Measures

Primary Outcomes (1)

• 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

  The primary objective is to compare the mean change in stability at 12 weeks minus value at baseline (day 1)after surgery of the "index implant" between coated and uncoated implants. An ISQ (Implant Stability Quotient) probe is used to measure the stability of the implant ISQ (Implant Stability Quotient) scale is 1-100 1 No stability 100 stability The aim is to get as close to a 100 as possible

  12 weeks

Secondary Outcomes (10)

• To Compare Absolute ISQ (Implant Stability Quotient) Highest Values Between Coated and Uncoated Implants for the "Index Implant" at Week 8 and Week 12

  week 8 and week 12

• Incidence of Post-surgery Complications and Adverse Events

  Day1 to week 12

• Change in ISQ (Implant Stability Quotient) Highest Value for the "Index Implant"

  Day 1 to week 8

• Change in ISQ Highest Value for All Other Implants

  week 8 and week 12

• Absolute ISQ (Implant Stability Quotient) Highest Value for All Other Implants

  Week 8 and 12

Study Arms (2)

Zolidd One ExHex

ACTIVE COMPARATOR

Coated titanium implant

Device: Zolidd One ExHex; Device: One ExHex

One ExHex

SHAM COMPARATOR

Uncoated titanium implant

Device: Zolidd One ExHex; Device: One ExHex

Interventions

Zolidd One ExHex DEVICE

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.

One ExHex; Zolidd One ExHex

One ExHex DEVICE

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.

One ExHex; Zolidd One ExHex

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Addbio AB: lead

Study Sites (3)

Dingletandläkarna

Dingle, 45561, Sweden

Location

Praktikertjänst AB Holmgatans Tandläkarmottagning

Falun, 79171, Sweden

Location

Käk-kirurgiska Kliniken, Näl

Trollhättan, 46185, Sweden

Location

Results Point of Contact

• Title: Ulf Sewerin, CEO
• Organization: AddBio AB

ulf.sewerin@addbio.se

+46708797988

Study Officials

• Christer Dahlin, DDS, PhD

  Käk kirurgiska kliniken NÄL, Trollhättan, Sweden

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel groups ration 1;1

Study Record Dates

• First Submitted: September 13, 2017
• First Posted: September 14, 2017
• Study Start: September 1, 2017
• Primary Completion: July 30, 2020
• Study Completion: October 1, 2020
• Last Updated: March 22, 2022
• Results First Posted: March 22, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (3)