CompletedNot Applicable

Performance and Safety Use of the Nanostructured Titanium Dental Implant "KONTACT N"

France164 participantsStarted 2019-02-04

Plain-language summary

A multicenter prospective observational study in which aim is to illustrate the clinical outcome of dental implants "Kontact N"; and the effects of its nanostructured surface on the osseointegration and secondary stability without increasing the rate of peri-implantitis. All the enrolled patients will be eligible for one or multiple implant-supported fixed restoration(s) according to the routine clinical practice and the manufacturer's instruction for use.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Poor oral hygiene
. Bruxism, parafunctional habits, occlusion disorders and / or temporomandibular joints
. Infections and oral inflammation such as periodontitis, gingivitis
. Patient with metabolic disorders (eg diabetes mellitus) or bone disease that may compromise peri-implant tissue healing
. Heavy smoker (\> 10 cigarettes / day)
. Patient with a pathology or immunosuppressive therapy such as chemotherapy, radiotherapy
. Patient on prolonged steroid therapy
. Titanium / titanium alloy allergy

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Implant success rate

Timeframe: up to 12 months post-implantation

Peri-implantitis rate

Timeframe: 12 months post-implantation

Mean osseointegration period

Timeframe: From the implantation up to 12 months

Trial details

NCT IDNCT03582657

SponsorBiotech Dental

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2020-09-05

View on ClinicalTrials.gov More Dental Implant trials