Closure of Implant Emergence Profile

NCT03536156 | Unknown

• 2 other identifiers: RC31/18/01812018-A01269-46
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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

Conditions

Dental Implant

Keywords

Dental implant; Implant Emergence Profile

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The volume variation as a percentage of Vol T0.5 min and Vol T2 min

  5 minutes

• The null hypothesis H0 will be a zero variation

  2 years

• Hypothesis H1 will be a percentage of positive and successively larger variation of Vol T30 dry and Vol T2 min.

  2 years

Interventions

Four intra-oral optical impression taken successively OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital Toulouse

Toulouse, 31059, France

Location

Study Officials

• Antoine GALIBOURG

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antoine GALIBOURG

CONTACT

06 43 16 40 50; antoinegalibourg@gmail.com

Isabelle Olivier, PhD

CONTACT

05 61 77 70 51; olivier.i@chu-toulouse.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2018
• First Posted: May 24, 2018
• Study Start: August 1, 2018
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: July 11, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)