Closure of Implant Emergence Profile

Dental Implant Clinical Trial

— FPEI  

Official title:

Closure of Implant Emergence Profile

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03536156
• Other study ID #: RC31/18/0181
• Secondary ID: 2018-A01269-46
• Status: Not yet recruiting
• Start date: August 2018
• Est. completion date: August 2020

Study information

• Verified date: July 2018
• Source: University Hospital, Toulouse
• Contact: Antoine GALIBOURG
• Phone: 06 43 16 40 50
• Email: antoinegalibourg[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16
• Est. completion date: August 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dental Implant

Intervention

Other:
• Four intra-oral optical impression taken successively
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

Locations

Country	Name	City	State
France	University Hospital Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 minutes
Secondary	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.	5 minutes
Secondary	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.	2 years
Secondary	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.	2 years