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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dental Implants
• Intervention / Treatment: Device: Dental implant

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Daniele Moretto, Dr; Phone Number: 003951863310; Email: dott.daniele.moretto@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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)

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	From implant insertion until definitive prosthesis delivery (3 months after implant insertion). Time duration 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant treatment success	Implant loaded functionally after 1 year of implant placement	Until 1 year after implant insertion
Change in prosthetic protocol	3 months to definitive prosthesis placement in maxilla, 2 months in mandible due to ISQ trend	Until 1 year after implant insertion

Collaborators and Investigators

• Sponsor: Daniele Moretto

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: December 12, 2024
• First Submitted That Met QC Criteria: January 28, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 28, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2024-1806

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No