Dental ImplantsNCT06799871
RFA R-Evolution: a New Protocol to Avoid Implant Failure
An observational study of Dental Implants, run by Daniele Moretto.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Implants
- What is being tested?
- Dental implant
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2025to Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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
Who cannot join
- 1-year follow-up data not available
- Subject received major guided bone regeneration
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Dental Implants
- Being tested
- Dental implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental implantDevice
There is no intervention in the study. The participants have already received dental implant treatment and data will be collected retrospectively regarding the procedure
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From implant insertion until definitive prosthesis delivery (3 months after implant insertion). Time duration 3 months
Secondary outcomes (2)
Implant treatment success
Implant loaded functionally after 1 year of implant placement
Measured: 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
Measured: Until 1 year after implant insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study startJan 2025 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daniele Moretto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Daniele Moretto, Odontoiatri Associati, Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06799871
- Sponsor's protocol ID
- 2024-1806
- Status last verified
- Dec 2024
- First submitted
- 12 Dec 2024
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Single Cohort Mono-center Study on Trends in Implant Stability Measured by RFA
- ClinicalTrials.gov ID
- NCT06799871
- Acronym / sponsor ID
- 2024-1806
- Conditions
- Dental Implants
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Daniele MorettoUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 29 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 1-year follow-up data not available
- Subject received major guided bone regeneration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dental implantThere is no intervention in the study. The participants have already received dental implant treatment and data will be collected retrospectively regarding the procedure | Device | – |
Primary outcome
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)
2 secondary outcomes
Implant treatment success
Time frame: Until 1 year after implant insertion
Change in prosthetic protocol
Time frame: Until 1 year after implant insertion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Implants, run by Daniele Moretto.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniele Moretto, Dr (003951863310, dott.daniele.moretto@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resonance frequency analysis (RFA) trends (time frame: From implant insertion until definitive prosthesis delivery (3 months after implant insertion). Time duration 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.