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

NCT06799871 | Not Yet Recruiting

• 1 other identifier: 2024-1806
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dental Implants

Outcome Measures

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)

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

Secondary Outcomes (2)

• Implant treatment success

  Until 1 year after implant insertion

• Change in prosthetic protocol

  Until 1 year after implant insertion

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Daniele Moretto: lead

MeSH Terms

Interventions

Dental Implants

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Daniele Moretto, Dr

CONTACT

003951863310; dott.daniele.moretto@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: January 29, 2025
• Study Start: January 1, 2025
• Primary Completion: June 1, 2025
• Study Completion: January 1, 2026
• Last Updated: January 29, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share