NCT02818374

Brief Summary

The purpose of this study is to evaluate the efficiency and the safe use of a new medical device to improve the oral accessibility of disabled people during the oral-dental examination.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 29, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

October 29, 2019

Status Verified

February 1, 2019

Enrollment Period

2.8 years

First QC Date

March 30, 2016

Last Update Submit

October 28, 2019

Conditions

Mental Handicap

Outcome Measures

Primary Outcomes (1)

  • Visibility and dental examination of incisor-canine sectors, premolars and molars using a probe, assessed by an oral accessibility score determined based on intra oral accessible areas with and without oral accessibility Spatula device

    score of 0 = no access to 12 = total accessibility

    1 day

Secondary Outcomes (2)

  • The safety of the spatula will be assessed by analyzing the reported adverse effects and their relative frequency

    1 day

  • The dental exam tolerance evaluation with and without Oral Accessibility Spatula

    1 day

Study Arms (1)

Disabled People with behavioral trouble

EXPERIMENTAL
Device: oral accessibility spatula (SAB)

Interventions

oral accessibility spatula (SAB)DEVICE
Disabled People with behavioral trouble

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Mental disability patient with behavioural troubles known or noticed during the approach of hand for dental examination
  • Venham Scale score of 2 and higher, meaning opposing, after an approach toward the oral cavity
  • Information of the responsible person for the patient, if necessary, and followed by the dated signed informed consent

You may not qualify if:

  • pregnant or nursing woman
  • lack of social security
  • people under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

CHU Dijon

Dijon, France

Location

Centre Hospitalier Emile Durkheim

Épinal, 88000, France

Location

Clinique Saint Francois

Haguenau, France

Location

CHR Metz-Thionville- Mercy Hospital

Metz, 57085, France

Location

CHRU Nancy

Nancy, 54000, France

Location

CHRU Strasbourg

Strasbourg, 67000, France

Location

CHR METZ THIONVILLE- Bel-Air Hospital

Thionville, 57126, France

Location

MeSH Terms

Interventions

Anesthesia, Spinal

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2016

First Posted

June 29, 2016

Study Start

March 1, 2016

Primary Completion

December 1, 2018

Study Completion

March 1, 2019

Last Updated

October 29, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(7)