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NCT Number: NCT06799871

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

This single-center retrospective study includes all consecutive participants treated since October 2021 for single or multiple edentulous sites (either healed or extracted). Only participants with a 1-year follow-up visit and RFA measurements at three or more time-points are included.

Participants will be consecutively included provided they meet all of the inclusion criteria and none of the exclusion criteria. As the data is anonymized, participants will not be contacted for consent.

Any additional post-hoc exclusion of participants will be thoroughly documented.

The primary endpoint of the study is:

-Occurrence of RFA trends (3 consecutive increasing or stable RFA values vs 3 consecutive decreasing RFA values)

Secondary endpoints:

  • Implant treatment success (implant loaded functionally) after 1 year of implant placement
  • Change in prosthetic protocol (3 months to definitive prosthesis placement in maxilla, 2 months in mandible) due to ISQ trend

Participants have already received dental implant(s) at surgery visit. Implant Stability Quotient (ISQ) was assessed after implant placement. Depending on the trends in ISQ, implants were loaded with provisional and the final prosthesis and followed up at least until 1 year after surgery.

Data collection methods Data will be collected by automatic extraction from the clinic's patient management system and will for statistical analysis.

Implant is considered survived if it is in-situ. Implant treatment success is defined as implant loaded functionally.

Demographic data will be collected in the automatic extraction of the data and used to access participant's eligibility to partake in the study.

Any relevant medical history of participants will be collected in the automatic extraction as well. Demographic and medical history data will also be part of the data analysis.

At interim and 1-year follow-up visits, prosthetic parameters will be collected.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 1-year follow-up data not available
  • Subject received major guided bone regeneration

Treatment and study plan

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

Primary outcomes

  1. Resonance frequency analysis (RFA) trends

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

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

Secondary outcomes

  1. Implant treatment success

    Time frame: Until 1 year after implant insertion

    Implant loaded functionally after 1 year of implant placement

  2. Change in prosthetic protocol

    Time frame: Until 1 year after implant insertion

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

Study contacts

Contact information is provided by the study sponsor or research team.

Daniele Moretto, Dr

CONTACT

[email protected]

003951863310

Sponsors and collaborators

Lead sponsor

Daniele Moretto

Other

Registry information

Official study title

Retrospective Single Cohort Mono-center Study on Trends in Implant Stability Measured by RFA

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jan 29, 2025
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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