Dental ImplantFPEINCT03536156
Closure of Implant Emergence Profile
An observational study of Dental Implant, run by University Hospital, Toulouse at 1 site in France.
Trial summary
In the case of unitary edentulousness, a dental implant is a prosthetic device fixed in the bone which makes it possible to receive a fixed dental prosthesis (crown). Peri-implant soft tissues (gums) play an essential role in the integration of the crown. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Implant
- What is being tested?
- Four intra-oral optical impression taken successively
- Type of treatment
- Pill or oral medicine
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2018to Aug 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient from the Department of Dentistry who has received an implant in the maxillary or mandible, anterior sector or 1st premolar, and presents himself for the prosthetic stages of the implant treatment
Who may be able to join
- Patient from the Department of Dentistry who has received an implant in the maxillary or mandible, anterior sector or 1st premolar, and presents himself for the prosthetic stages of the implant treatment (realization of the crown of use),
- Patient affiliated with Social Security,
- Patient having given no objection to his participation in this study
- Good written and oral comprehension of French
Who cannot join
- Patient who has received an implant intended to receive a removable prosthesis.
- Patient under court bail, tutelage
Trial locations and contacts
1 site in 1 country.
France1 site
University Hospital Toulouse
Toulouse, 31059
Antoine GALIBOURG, 06 43 16 40 50 ext. 33, antoinegalibourg@gmail.com
Isabelle Olivier, PhD, 05 61 77 70 51 ext. 33, olivier.i@chu-toulouse.fr
About this study
In the case of unitary edentulousness, a dental implant is a prosthetic device fixed in the bone which makes it possible to receive a fixed dental prosthesis (crown). Peri-implant soft tissues (gums) play an essential role in the integration of the crown. Indeed, the implant gingival emergence profile provides an aesthetic integration mimicking that of a natural tooth. This implant emergence profile (EIP) is modeled during the surgical and / or prosthetic phases.
The problem comes from the labile character of the EIP (Emergence Implant Profile). If the literature evokes this problem, the instability of the volume of the EIP during the impression phases has never been measured. Moreover, the three-dimensional behavior of the EIP over time (kinetic) during the acquisition phases is not known.
Objective study of the mobility of gingival tissues of the implant emergence profile (IEP), using an intra-oral optical camera, would scientifically measure the labile aspect of the IEP and improve the procedure of registration of peri-implant soft tissues
Read the detailed description
Objective study of the mobility of gingival tissues of the implant emergence profile (IEP), using an intra-oral optical camera, would scientifically measure the labile aspect of the IEP and improve the procedure of registration of peri-implant soft tissues.
The main objective is to study the effect of removal of a healing abutment on the closure of the EIP volume at 5 minutes.
This non-interventional study is a prospectively recruited research of the participants and a cross-sectional measure of the judgment criteria (during a single visit). The study is mono-centric, it will take place in the odontology department of Toulouse Hospital.
The question is to know if the decrease in the volume of the PEI is significant during the preparatory phase of the implant impression where the PEI is no longer supported by the healing screw over a period of 5 minutes.
Optical impressions are designed to record adjacent implant site teeth and peri-implant soft tissue PEI using a Optical Camera. The optical camera works like a camera and does not come into contact with the patient's mucous membranes or teeth. The images obtained are saved in STL format on an anonymized file.
- Conditions
- Dental Implant
- Being tested
- Four intra-oral optical impression taken successively
- Keywords
- Dental implant, Implant Emergence Profile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Four intra-oral optical impression taken successivelyOther
Four intra-oral optical impression images will be taken successively on a patient:
Optical impressions are designed to record adjacent implant site teeth and peri-implant soft tissue PEI using an Optical Camera. The optical camera works like a camera and does not come into contact with the patient's mucous membranes or teeth. The images obtained are saved in STL format on an anonymized file.
The 4 aligned surfaces thus obtained will be cut using a 3D image processing software. A fixed cylinder will extract the PEI from the 4 surfaces. The volume of these 4 PEIs at T0 min, T30 sec, T2 min and T5 min will be calculated using a software
What is being measured
The primary outcome is the main question the study is designed to answer.
Calculation of the volume of the PEI from to T5 min
Calculation of the volume of the PEI at T0 min from T5 min :
They will be named respectively:
- Flight T0 min : The reference volume is the volume of the PEI at T0 min, it corresponds to the volume of the healing screw created during the mucosal healing phase and which must be kept for the production of the crown of use. It will be called: Vol T0 min. Hypothesis H0 is that Vol T0 min is fixed over time.
If a volume change of 10% is observed, it is assumed that the clinical consequences are real and that the IEP volume will be undersized compared to the reference IEP. This will have aesthetic and functional consequences.
The measurement tool of the study is the intraoral scanner.
Measured: 5 minutes
Secondary outcomes (3)
The volume variation as a percentage of Vol T0.5 min and Vol T2 min
The volume variation as a percentage of Vol T0.5 min and Vol T2 min relative to the reference volume Vol T0 min.
Measured: 5 minutes
The null hypothesis H0 will be a zero variation
The null hypothesis H0 will be a zero variation : a T30 Vol with a Vol T2 min Vol equal to Vol T0 min.
This Reference Volume is compared to the PEI volume at 5 min: Vol T5 min. If a volume change of 10% is observed, it is assumed that the clinical consequences are real and that the IEP volume will be undersized compared to the reference PEI. This will have aesthetic and functional consequences.
The reference volume is the volume of the PEI at T0 min, it corresponds to the volume of the healing screw created during the mucosal healing phase and which must be kept for the production of the crown of use. It will be called: Vol T0 min. Hypothesis H0 is that Vol T0 min is fixed over time.
Measured: 2 years
Hypothesis H1 will be a percentage of positive and successively larger variation of Vol T30 dry and Vol T2 min.
Hypothesis H1 will be a percentage of positive and successively larger variation of Vol T30 dry and Vol T2 min.
This Reference Volume is compared to the PEI volume at 5 min: Vol T5 min. If a volume change of 10% is observed, it is assumed that the clinical consequences are real and that the PEI volume will be undersized compared to the reference PEI. This will have aesthetic and functional consequences.
The reference volume is the volume of the PEI at T0 min, it corresponds to the volume of the healing screw created during the mucosal healing phase and which must be kept for the production of the crown of use. It will be called: Vol T0 min. Hypothesis H0 is that Vol T0 min is fixed over time.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study startAug 2018 (estimated)
- Primary completionAug 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine GALIBOURG, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03536156
- Sponsor's protocol ID
- RC31/18/0181
- Other IDs
- 2018-A01269-46
- Acronym
- FPEI
- Status last verified
- Jul 2018
- First submitted
- 9 May 2018
- Last updated
- 11 Jul 2018
- 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 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closure of Implant Emergence Profile
- ClinicalTrials.gov ID
- NCT03536156
- Acronym / sponsor ID
- FPEI / RC31/18/0181
- Conditions
- Dental Implant
- Keywords
- Dental implant, Implant Emergence Profile
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Aug 2018 (estimated)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 24 May 2018 (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.
In the case of unitary edentulousness, a dental implant is a prosthetic device fixed in the bone which makes it possible to receive a fixed dental prosthesis (crown). Peri-implant soft tissues (gums) play an essential role in the integration of the crown. Indeed, the implant gingival emergence profile provides an aesthetic integration mimicking that of a natural tooth. This implant emergence profile (EIP) is modeled during the surgical and / or prosthetic phases.
The problem comes from the labile character of the EIP (Emergence Implant Profile). If the literature evokes this problem, the instability of the volume of the EIP during the impression phases has never been measured. Moreover, the three-dimensional behavior of the EIP over time (kinetic) during the acquisition phases is not known.
Objective study of the mobility of gingival tissues of the implant emergence profile (IEP), using an intra-oral optical camera, would scientifically measure the labile aspect of the IEP and improve the procedure of registration of peri-implant soft tissues
Detailed description
Objective study of the mobility of gingival tissues of the implant emergence profile (IEP), using an intra-oral optical camera, would scientifically measure the labile aspect of the IEP and improve the procedure of registration of peri-implant soft tissues.
The main objective is to study the effect of removal of a healing abutment on the closure of the EIP volume at 5 minutes.
This non-interventional study is a prospectively recruited research of the participants and a cross-sectional measure of the judgment criteria (during a single visit). The study is mono-centric, it will take place in the odontology department of Toulouse Hospital.
The question is to know if the decrease in the volume of the PEI is significant during the preparatory phase of the implant impression where the PEI is no longer supported by the healing screw over a period of 5 minutes.
Optical impressions are designed to record adjacent implant site teeth and peri-implant soft tissue PEI using a Optical Camera. The optical camera works like a camera and does not come into contact with the patient's mucous membranes or teeth. The images obtained are saved in STL format on an anonymized file.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient from the Department of Dentistry who has received an implant in the maxillary or mandible, anterior sector or 1st premolar, and presents himself for the prosthetic stages of the implant treatment
Key inclusion criteria (4 listed)
- Patient from the Department of Dentistry who has received an implant in the maxillary or mandible, anterior sector or 1st premolar, and presents himself for the prosthetic stages of the implant treatment (realization of the crown of use),
- Patient affiliated with Social Security,
- Patient having given no objection to his participation in this study
- Good written and oral comprehension of French
Key exclusion criteria (2 listed)
- Patient who has received an implant intended to receive a removable prosthesis.
- Patient under court bail, tutelage
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 |
|---|---|---|
| Four intra-oral optical impression taken successivelyFour intra-oral optical impression images will be taken successively on a patient: Optical impressions are designed to record adjacent implant site teeth and peri-implant soft tissue PEI using an Optical Camera. The optical camera works like a camera and does not come into contact with the patient's mucous membranes or teeth. The images obtained are saved in STL format on an anonymized file. The 4 aligned surfaces thus obtained will be cut using a 3D image processing software. A fixed cylinder will extract the PEI from the 4 surfaces. The volume of these 4 PEIs at T0 min, T30 sec, T2 min and T5 min will be calculated using a software | Other | – |
Primary outcome
Calculation of the volume of the PEI from to T5 min
Time frame: 5 minutes
Calculation of the volume of the PEI at T0 min from T5 min : They will be named respectively: - Flight T0 min : The reference volume is the volume of the PEI at T0 min, it corresponds to the volume of the healing screw created during the mucosal healing phase and which must be kept for the production of the crown of use. It will be called: Vol T0 min. Hypothesis H0 is that Vol T0 min is fixed over time. If a volume change of 10% is observed, it is assumed that the clinical consequences are real and that the IEP volume will be undersized compared to the reference IEP. This will have aesthetic and functional consequences. The measurement tool of the study is the intraoral scanner.
3 secondary outcomes
The volume variation as a percentage of Vol T0.5 min and Vol T2 min
Time frame: 5 minutes
The null hypothesis H0 will be a zero variation
Time frame: 2 years
Hypothesis H1 will be a percentage of positive and successively larger variation of Vol T30 dry and Vol T2 min.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2018.
- 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.
Antoine GALIBOURG principal investigator
University Hospital, Toulouse
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 Dental Implant, run by University Hospital, Toulouse at 1 site in France.
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: status not confirmed, as of the sponsor's last update on 11 Jul 2018. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antoine GALIBOURG (06 43 16 40 50 ext. 33, antoinegalibourg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calculation of the volume of the PEI from to T5 min (time frame: 5 minutes). 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 11 Jul 2018.