Health TrialsbyHealthPanel

RFA R-Evolution: a New Protocol to Avoid Implant Failure

ConditionDental Implants
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDaniele Moretto

About this trial

The main objective of this study is to assess the impact of confounding factors such as jaw, implant position, indication, smoking status, implant dimension, and medical history on RFA trends. In addition, this study aims to explore correlations of RFA trend, with the goal of using ISQ trends as an indicator for treatment protocol decisions (e.g. time of loading). Participants have already received dental implant as per clinic's standard protocol. Information regarding Implant Stability Quotient (ISQ) measurements performed at any time point until 1-year follow-up will be collected. The principal investigator protocol regarding the use of ISQ measure to define time of implant loading will also be assessed. Only participants followed up at least until one year after implant placement will be included in the data collection.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant received implant treatment NobelReplace, NobelActive or NobelParallel implants on or after October 2021 (with TiUnite or TiUltra surfaces)

Participant was at least 18 years old at the time of surgery

Participant attended a follow-up visit at least 1-year after surgery

Implant stability was assessed by means of RFA at a minimum of three time-points

Disqualifiers

1-year follow-up data not available

Subject received major guided bone regeneration

Trial population

At least 100 consecutive subjects treated with the RFA-trend protocol since October 2021 are included. To ensure sufficient sampling of underrepresented indications and due to the novelty of this decision-making protocol, adaptive sample size determination will be used. Participant received implant treatment NobelReplace, NobelActive or NobelParallel implants on or after October 2021 (with TiUnite or TiUltra surfaces)

Trial design

Design model

Other

Time perspective

Retrospective

Treatments tested in this trial

  • Dental implant

    Device

    There is no intervention in the study. The participants have already received dental implant treatment and data will be collected retrospectively regarding the procedure

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Resonance frequency analysis (RFA) trends

Occurrence of Resonance frequency analysis trends (3 consecutive increasing or stable implant stability quotient (ISQ) values vs 3 consecutive decreasing ISQ values)

Time frame
From implant insertion until definitive prosthesis delivery (3 months after implant insertion). Time duration 3 months

Secondary outcomes

1

Implant treatment success

Implant loaded functionally after 1 year of implant placement

Time frame
Until 1 year after implant insertion
2

Change in prosthetic protocol

3 months to definitive prosthesis placement in maxilla, 2 months in mandible due to ISQ trend

Time frame
Until 1 year after implant insertion

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Daniele Moretto

Lead sponsor

Odontoiatri Associati, Bologna

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: