RFA R-Evolution: a New Protocol to Avoid Implant Failure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dental implant.
- Who it may be relevant to
- Registry conditions: Dental Implants. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Retrospective Single Cohort Mono-center Study on Trends in Implant Stability Measured by RFA
Overview
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.
Interventions
- Device Dental implant
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 outcome measures
- Resonance frequency analysis (RFA) trends [Time frame: From implant insertion until definitive prosthesis delivery (3 months after implant insertion). Time duration 3 months]
Secondary outcome measures (2)
- Implant treatment success [Time frame: Until 1 year after implant insertion]
- Change in prosthetic protocol [Time frame: Until 1 year after implant insertion]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06799871 · 2024-1806