Implant Site ReactionNCT06146244
Comparison of ISQ in Implants Placed in Antral Area on Native Bone vs Regenerated Bone
An observational study of Implant Site Reaction, run by European University of Madrid at 1 site in Spain.
Trial summary
Compare ISQ values of implants placed in antral area in native bone vs regenerated bone with a follow-up at 3 months to compare values changes. Read more about this study
- Who is it for?
- Ages 23 to 85 years
- Conditions the study is for
- Implant Site Reaction
- What is being tested?
- sinus lift and resonance frequency analysis
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 132 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2018to 1 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 23 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study group is made up of adult patients from the UEM Dental University Clinic, from September 2017 to September 2018, who attended the Master's Degree in Advanced Oral Implantology and who were informed of the study and signed the informed consent.
Who may be able to join
- Adult patients
- Total superior edentulism or antral zone edentulism
- Accepted study and signed inform consent
Who cannot join
- Patients under 23 years old
- Non accepted study or signed inform consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Value of Resonance Frequency Analysis (ISQ) in Implants Placed in Antral Area on Native Bone vs Value Obtained in Implants Placed in Antral Area on Regenerated Bone and Its Evolution After 3 Months
Compare ISQ values of implants placed in antral area in native bone vs regenerated bone with a follow-up at 3 months to compare values changes.
Read the detailed description
The stability of dental implants is influenced by the type of bone in which the implant is placed. Native bone tends to provide better initial stability due to its density and quality, while regenerated bone, it is logical to think that it may present less stability due to the quality of the generated bone and the presence of defects in the treated area.
In this study it has been observed that after 3 months more stability is observed in the antral area, measured in ISQ resonance frequency in implants on regenerated bone, which surprises us and this result is explained in detail in said study.
- Conditions
- Implant Site Reaction
- Being tested
- sinus lift, resonance frequency analysis
- Keywords
- Implant placement, native bone, regenerated bone, resonance frequency analysis, ISQ value, Ostell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sinus liftProcedure or surgery
Also called alveolar preservation
Implant placement on grafted sinus vs antral autogenous bone
resonance frequency analysisDevice
Also called ISQ
analysis of the ISQ evolution and its changes after 3 months of placing the implant in native or regenerated bone, always in the antral area
| Study group | Role | What they receive |
|---|---|---|
| Native bone | the evolution of the SSI and its change after 3 months of placing the implant in native bone in the antral area Receives: Device: resonance frequency analysis | |
| Regenerated Bone | the evolution of the SSI and its change after 3 months of placing the implant in regenerated bone in the antral area Receives: Procedure: sinus lift; Device: resonance frequency analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resonance frequency analysis (ISQ) measurements
The day of surgery, data were collected by vestibular and palatal, in addition, the mean of both measurements was taken and ISQ data were collected vertically to complete all the information. After 3 months of implant placement we recorded the same measurements and compared them in native and regenerated bone.
Measured: 3 months
Secondary outcomes (2)
Insertion torque measurements
Analysis of the insertion torque values measured in Newtons per centimeter (Ncm) and comparing the results of both groups.
Measured: During implant placement
Changes in the marginal bone
Analysis of the changes in the marginal bone three months after implant placement
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start1 Mar 2018
- Primary completion1 Mar 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant Site ReactionStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- European University of Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara Molina Ponte, European University of Madrid
- Investigators
- Sergio Trapote Mateo, PhD, Study director, European University of Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06146244
- Sponsor's protocol ID
- CIPI/18/008
- Status last verified
- Nov 2023
- First submitted
- 14 Nov 2023
- Last updated
- 24 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Value of Resonance Frequency Analysis (ISQ) in Implants Placed in Antral Area on Native Bone vs Value Obtained in Implants Placed in Antral Area on Regenerated Bone and Its Evolution After 3 Months
- ClinicalTrials.gov ID
- NCT06146244
- Acronym / sponsor ID
- CIPI/18/008
- Conditions
- Implant Site Reaction
- Keywords
- Implant placement, native bone, regenerated bone, resonance frequency analysis, ISQ value, Ostell
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- European University of MadridUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 24 Nov 2023 (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.
Compare ISQ values of implants placed in antral area in native bone vs regenerated bone with a follow-up at 3 months to compare values changes.
Detailed description
The stability of dental implants is influenced by the type of bone in which the implant is placed. Native bone tends to provide better initial stability due to its density and quality, while regenerated bone, it is logical to think that it may present less stability due to the quality of the generated bone and the presence of defects in the treated area.
In this study it has been observed that after 3 months more stability is observed in the antral area, measured in ISQ resonance frequency in implants on regenerated bone, which surprises us and this result is explained in detail in said study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Native bone | – | Device: resonance frequency analysisthe evolution of the SSI and its change after 3 months of placing the implant in native bone in the antral area |
| Regenerated Bone | – | Procedure: sinus lift, Device: resonance frequency analysisthe evolution of the SSI and its change after 3 months of placing the implant in regenerated bone in the antral area |
Who may qualify
- Ages
- 23 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study group is made up of adult patients from the UEM Dental University Clinic, from September 2017 to September 2018, who attended the Master's Degree in Advanced Oral Implantology and who were informed of the study and signed the informed consent.
Key inclusion criteria (3 listed)
- Adult patients
- Total superior edentulism or antral zone edentulism
- Accepted study and signed inform consent
Key exclusion criteria (2 listed)
- Patients under 23 years old
- Non accepted study or signed inform consent
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 |
|---|---|---|
| sinus liftAlso: alveolar preservationImplant placement on grafted sinus vs antral autogenous bone | Procedure or surgery | Regenerated Bone |
| resonance frequency analysisAlso: ISQanalysis of the ISQ evolution and its changes after 3 months of placing the implant in native or regenerated bone, always in the antral area | Device | Native bone, Regenerated Bone |
Primary outcome
Resonance frequency analysis (ISQ) measurements
Time frame: 3 months
The day of surgery, data were collected by vestibular and palatal, in addition, the mean of both measurements was taken and ISQ data were collected vertically to complete all the information. After 3 months of implant placement we recorded the same measurements and compared them in native and regenerated bone.
2 secondary outcomes
Insertion torque measurements
Time frame: During implant placement
Changes in the marginal bone
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- 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. This study is not recruiting at the moment.
Sergio Trapote Mateo, PhD study director
European University of Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Implant Site Reaction, run by European University of Madrid at 1 site in Spain.
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 3 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: finished, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resonance frequency analysis (ISQ) measurements (time frame: 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 24 Nov 2023.