Closure of Implant Emergence Profile

NCT ID: NCT03536156

Last Updated: 2018-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-31

Study Completion Date

2020-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Dental Implant

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Antoine GALIBOURG

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital Toulouse

Toulouse, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Antoine GALIBOURG

Role: CONTACT

06 43 16 40 50 ext. 33

Isabelle Olivier, PhD

Role: CONTACT

05 61 77 70 51 ext. 33

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Antoine GALIBOURG

Role: primary

06 43 16 40 50 ext. 33

Isabelle Olivier, PhD

Role: backup

05 61 77 70 51 ext. 33

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2018-A01269-46

Identifier Type: OTHER

Identifier Source: secondary_id

RC31/18/0181

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.