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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06364020
Other study ID # APHP230067
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 2024
Est. completion date April 2025

Study information

Verified date April 2024
Source Assistance Publique - Hôpitaux de Paris
Contact Caroline Mocquot, MCU-PH
Phone +33622971627
Email caroline.mocquot@aphp.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Tooth wear is a cumulative loss of surface area at the expense of mineralized tooth tissue caused by physical or physicochemical processes (erosion, attrition, abrasion), i.e., excluding carious lesion, resorption, or trauma. Non-carious cervical lesions (NCCL) correspond to hard tissue loss in the cervical area of the tooth by processes not related to caries. The prevalence of NCCL varies between 5 and 85% depending on the study and the severity of cervical wear increases with age. A 2020 systematic review estimates the prevalence of NCCL at 46.7%. NCCL are frequent pathologies caused by changes in lifestyle and diet. The reasons for consultation are diverse and varied, either symptomatic (sensitivities) functional (food retention) or aesthetic. The prevalence and severity of wear increases with age. It is generally accepted that lesions are not generated by a single factor but result from a combination of factors, such as erosion, abrasion or abfraction. The clinical appearance of NCCLs may vary depending on the type and severity of the etiologic factors involved. Proper diagnosis of this type of lesion requires a comprehensive knowledge of the different etiologies as well as their multifactorial aspects through focused questioning and careful clinical observation. Due to the multifactorial and interrelated etiologies, accurate diagnosis of NCCLs is challenging. Prevention and proper management of NCCL requires an understanding of the etiology and risk factors related to mental disorders such as depression, stress and anxiety or pathological behaviors such as traumatic brushing or bruxism. Wear lesions can be aggravated by gastroesophageal reflux and eating disorders resulting from mental disorders that are devastating to dental tissue. The decision to monitor NCCLs rather than intervene should be based on the progression of the lesions and how they compromise the vitality, function, and aesthetics of the teeth. During the management of patients with NCCL, we observe that they show signs of anxiety. Therefore, the objective is to assess the level of anxiety in patients with NCCL and to compare it to that of patients without NCCL. We wish to carry out an observational survey from a prospective cohort at the Rothschild Hospital.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date April 2025
Est. primary completion date April 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Age: between 18 and 60 years old; - Specialized periodontal consultation. Exclusion Criteria: - 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.

Study Design


Locations

Country Name City State
France Hôpital Rothschild - Service Odontologie Paris

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 To investigate the association between bruxism and the presence of NCCL. SCOFF Questionnaire (Kutz et al. 2020) During inclusion visit
Secondary To investigate the association between eating disorders and the presence of NCCL. Bruxism questionnaire (Khoury & al. 2016) During inclusion visit
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