Clinical trial NCT06799871: RFA R-Evolution: a New Protocol to Avoid Implant Failure
Official title: Retrospective Single Cohort Mono-center Study on Trends in Implant Stability Measured by RFA
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Dental Implants
Lead sponsor: Odontoiatri Associati, Bologna
Sponsor class: OTHER
First posted: 2025-01-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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)

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Resonance frequency analysis (RFA) trends
timeFrame: From implant insertion until definitive prosthesis delivery (3 months after implant insertion). Time duration 3 months
Secondary outcomes:
measure: Implant treatment success
timeFrame: Until 1 year after implant insertion
measure: Change in prosthetic protocol
timeFrame: Until 1 year after implant insertion
Other outcomes:
Locations:
Study officials:
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