AnxietyLACISNCT06364020
Assessment of Risk Factors in Patients With Non-carious Cervical Lesions
An observational study of Anxiety and Stress, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Anxiety, Stress, Non-carious Cervical Lesions
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2024to Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- Age: between 18 and 60 years old;
- Specialized periodontal consultation.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Rothschild - Service Odontologie
Paris, 75012
Caroline Mocquot, MCU-PH, +33622971627, caroline.mocquot@aphp.fr
Maria Clotilde Carra, Professor, +33630746555, mariaclotilde.carra@aphp.fr
About this study
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.
Read the 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.
- Conditions
- Anxiety, Stress, Non-carious Cervical Lesions
- Keywords
- Periodontics, Anxiety,, Gingival recession, Feeding and Eating disorders, Bruxism, Restorative dentistry, NonCarious Cervical Lesions
- Medical subject headings
- Anxiety Disorders, Gingival Recession, Feeding and Eating Disorders, Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the association between anxiety/stress and the presence of NCCL.
Assessment questionnaire DASS21 (Depression Anxiety Stress (DASS-21 ; Lovibond \& Lovibond, 1995).
Measured: During inclusion visit
Secondary outcomes (2)
To investigate the association between bruxism and the presence of NCCL.
SCOFF Questionnaire (Kutz et al. 2020)
Measured: During inclusion visit
To investigate the association between eating disorders and the presence of NCCL.
Bruxism questionnaire (Khoury \& al. 2016)
Measured: During inclusion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study startApr 2024 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline Mocquot, MCU-PH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06364020
- Sponsor's protocol ID
- APHP230067
- Acronym
- LACIS
- Status last verified
- Apr 2024
- First submitted
- 9 Apr 2024
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Risk Factors in Patients With Non-carious Cervical Lesions
- ClinicalTrials.gov ID
- NCT06364020
- Acronym / sponsor ID
- LACIS / APHP230067
- Conditions
- Anxiety, Stress, Non-carious Cervical Lesions
- Keywords
- Periodontics, Anxiety,, Gingival recession, Feeding and Eating disorders, Bruxism, Restorative dentistry, NonCarious Cervical Lesions
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Apr 2024 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 15 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- Age: between 18 and 60 years old;
- Specialized periodontal consultation.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To investigate the association between anxiety/stress and the presence of NCCL.
Time frame: During inclusion visit
Assessment questionnaire DASS21 (Depression Anxiety Stress (DASS-21 ; Lovibond \& Lovibond, 1995).
2 secondary outcomes
To investigate the association between bruxism and the presence of NCCL.
Time frame: During inclusion visit
To investigate the association between eating disorders and the presence of NCCL.
Time frame: During inclusion visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline Mocquot, MCU-PH principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety and Stress, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caroline Mocquot, MCU-PH (+33622971627, caroline.mocquot@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate the association between anxiety/stress and the presence of NCCL. (time frame: During inclusion visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2024.