Clinical trial NCT03536156: Closure of Implant Emergence Profile
Official title: Closure of Implant Emergence Profile
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dental Implant
Keywords: Dental implant
Implant Emergence Profile
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2018-05-24
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Patient who has received an implant intended to receive a removable prosthesis.
* Patient under court bail, tutelage

Primary outcomes:
measure: Calculation of the volume of the PEI from to T5 min
timeFrame: 5 minutes
Secondary outcomes:
measure: The volume variation as a percentage of Vol T0.5 min and Vol T2 min
timeFrame: 5 minutes
measure: The null hypothesis H0 will be a zero variation
timeFrame: 2 years
measure: Hypothesis H1 will be a percentage of positive and successively larger variation of Vol T30 dry and Vol T2 min.
timeFrame: 2 years
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Antoine GALIBOURG
role: PRINCIPAL_INVESTIGATOR
References: