- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06364020
Assessment of Risk Factors in Patients With Non-carious Cervical Lesions (LACIS)
Study Overview
Status
Conditions
Detailed 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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Caroline Mocquot, MCU-PH
- Phone Number: +33622971627
- Email: caroline.mocquot@aphp.fr
Study Contact Backup
- Name: Maria Clotilde Carra, Professor
- Phone Number: +33630746555
- Email: mariaclotilde.carra@aphp.fr
Study Locations
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Paris, France, 75012
- Hôpital Rothschild - Service Odontologie
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Contact:
- Caroline Mocquot, MCU-PH
- Phone Number: +33622971627
- Email: caroline.mocquot@aphp.fr
-
Contact:
- Maria Clotilde Carra, Professor
- Phone Number: +33630746555
- Email: mariaclotilde.carra@aphp.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
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.
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To investigate the association between anxiety/stress and the presence of NCCL.
Time Frame: During inclusion visit
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Assessment questionnaire DASS21 (Depression Anxiety Stress (DASS-21 ; Lovibond & Lovibond, 1995).
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During inclusion visit
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To investigate the association between bruxism and the presence of NCCL.
Time Frame: During inclusion visit
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SCOFF Questionnaire (Kutz et al. 2020)
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During inclusion visit
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To investigate the association between eating disorders and the presence of NCCL.
Time Frame: During inclusion visit
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Bruxism questionnaire (Khoury & al. 2016)
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During inclusion visit
|
Collaborators and Investigators
Investigators
- Principal Investigator: Caroline Mocquot, MCU-PH, Assistance Publique - Hôpitaux de Paris
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- APHP230067
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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