NCT06364020

Brief Summary

In the management of patients with noncarious cervical lesions (NCCL), we observe that they frequently present signs of anxiety, traumatic brushing, bruxism or eating disorders. These multifactorial and interrelated etiologies make diagnosis and management difficult. Furthermore, in the literature, there is a lack of studies that evaluate the relationship between these risk factors and NCCL. A better understanding of the etiology and risk factors would help to optimize patient management and direct patients to the most appropriate therapies.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2024

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 15, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

April 15, 2024

Status Verified

April 1, 2024

Enrollment Period

1 year

First QC Date

April 9, 2024

Last Update Submit

April 9, 2024

Conditions

Keywords

PeriodonticsAnxiety,Gingival recessionFeeding and Eating disordersBruxismRestorative dentistryNonCarious Cervical Lesions

Outcome Measures

Primary Outcomes (1)

  • To investigate the association between anxiety/stress and the presence of NCCL.

    Assessment questionnaire DASS21 (Depression Anxiety Stress (DASS-21 ; Lovibond \& Lovibond, 1995).

    During inclusion visit

Secondary Outcomes (2)

  • To investigate the association between bruxism and the presence of NCCL.

    During inclusion visit

  • To investigate the association between eating disorders and the presence of NCCL.

    During inclusion visit

Study Arms (1)

Adult patients seen in specialized periodontology consultation at Rothschild Hospital

The population that will be studied will be patients received in the first specialized clinical periodontology consultation aged between 18 and 60 years.

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Adult patients seen in specialized periodontology consultation at Rothschild Hospital. During the initial consultation, according to current protocol and practice, the practitioner performs a complete examination of the mouth and teeth and indicates in the patient's medical record the possible presence of oral pathologies, including the diagnosis of NCCL. The presence of NCCL is judged on all teeth and defined by the presence of 4 or more NCCLs with a depth (buccolingual) and height (occlusogingival) greater than or equal to 2 mm.

You may qualify if:

  • Age: between 18 and 60 years old;
  • Specialized periodontal consultation.

You may not qualify if:

  • Patients with co-morbidities that do not allow for adequate brushing of the teeth (Parkinson, Alzheimer...);
  • Patients with removable prothesis for two years or more;
  • Patients under guardianship or trusteeship.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Rothschild - Service Odontologie

Paris, 75012, France

Location

MeSH Terms

Conditions

Anxiety DisordersGingival RecessionFeeding and Eating DisordersBruxism

Condition Hierarchy (Ancestors)

Mental DisordersGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal AtrophySigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsTooth DiseasesHabitsBehavior

Study Officials

  • Caroline Mocquot, MCU-PH

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline Mocquot, MCU-PH

CONTACT

Maria Clotilde Carra, Professor

CONTACT

Study Design

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

Study Record Dates

First Submitted

April 9, 2024

First Posted

April 15, 2024

Study Start

April 1, 2024

Primary Completion

April 1, 2025

Study Completion

April 1, 2025

Last Updated

April 15, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations