NCT02167724

Brief Summary

The aim of this study is to know the bucco-dental status of patients with schizophrenia in Côte d'Or. Participation in this study will last only as long as it takes to:

  • carry out a bucco-dental examination: evaluation of dental plaque and calculus
  • take a blood sample to assess needs in vitamin C (only for patients included at DIJON CHU and CHS Chartreuse)
  • complete a 30-minute questionnaire: clinical data and answers to questions concerning dental hygiene and eating habits.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Sep 2014

Shorter than P25 for not_applicable schizophrenia

Geographic Reach
1 country

3 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

First Submitted

Initial submission to the registry

June 17, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 19, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

1.3 years

First QC Date

June 17, 2014

Last Update Submit

February 5, 2026

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Calculate the DMF index (Decayed, Missing, Filled)

    Baselines

Secondary Outcomes (2)

  • Calculate the simplified Oral Health Index (OHI-S)

    Baselines

  • Perception of oral health of patients observed

    Baselines

Study Arms (1)

Patients with schizophrenia

EXPERIMENTAL
Other: Bucco-dental examinationOther: Blood sampleOther: Clinical and social questionnaire

Interventions

Bucco-dental examinationOTHER
Patients with schizophrenia
Blood sampleOTHER
Patients with schizophrenia
Clinical and social questionnaireOTHER
Patients with schizophrenia

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who have provided consent
  • Patients over 18 years of age
  • Persons with schizophrenia according to the ICD 10 criteria and followed in hospital (complete or day hospital) in one of the hospitals taking part in the study

You may not qualify if:

  • Adult under guardianship
  • Patient not covered by national health insurance
  • Pregnant or breast-feeding women
  • Patients not stabilized from a psychiatric viewpoint
  • Patients experiencing an acute psychiatric episode
  • Impossibility to understand and /or poor understanding of French

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CHS La Chartreuse

Dijon, 21033, France

Location

CHU de DIJON

Dijon, 21079, France

Location

CH Semur-en-Auxois

Semur-en-Auxois, 21140, France

Location

Related Publications (1)

  • Denis F, Milleret G, Wallenhorst T, Carpentier M, Rude N, Trojak B. Oral health in schizophrenia patients: A French Multicenter Cross-Sectional Study. Presse Med. 2019 Feb;48(2):e89-e99. doi: 10.1016/j.lpm.2018.06.018. Epub 2019 Mar 8.

    PMID: 30853291RESULT

MeSH Terms

Conditions

Schizophrenia

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

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

Study Record Dates

First Submitted

June 17, 2014

First Posted

June 19, 2014

Study Start

September 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

February 9, 2026

Record last verified: 2026-02

Locations

FR(3)