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- Ensayo clínico NCT07615153
Impact of Distress Level, Sleep Quality and Occlusal Trauma on Periodontal Status Among Bruxers
Impact of Distress Level, Sleep Quality and Occlusal Trauma on Periodontal Status Among Bruxers - a Cross Sectional Study
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
The periodontium in sleep bruxism patients suffers from excessive occlusal force for long periods of time during sleep, the function of the periodontium in such patients may differ from that in patients without sleep bruxism.
Bruxism is associated with tooth wear, chipping, cracking, and fracture, tooth mobility, gingival recession, pain, and sensitivity. Tooth mobility can be a serious consequence of bruxism. Tooth mobility has been described as one of the common clinical signs of occlusal trauma. Progressive mobility may be suggestive of ongoing occlusal trauma, but assessments at different time points are necessary to make this determination.
Bruxism has multifactorial etiologies involving central nervous system regulation, psychosocial factors such as stress, and peripheral influences such as occlusal interferences. Psychological stress and poor sleep quality are commonly reported in individuals with sleep bruxism. Sleep disturbances have been linked to elevated muscle activity and increased parafunctional events, potentially contributing to adverse oral health outcomes. Additionally, poor sleep quality has been associated with diminished overall health and may exacerbate inflammatory responses, which are central to periodontal disease progression. These may contribute to adverse oral health outcomes by preventing the "rest and repair" cycle necessary for tissue health. Stress levels and poor sleep quality negatively affect systemic health. These effects are mediated through direct mechanisms such as systemic inflammation, oxidative stress, and immune system impairment, as well as indirect mechanisms involving associated compensatory behaviors. Given that inflammation and oxidative stress are key components in the pathogenesis of periodontitis. Previous epidemiological studies have identified high perceived stress and poor sleep quality as modifiable risk indicators for periodontitis. When stress levels remain chronically elevated and recovery is insufficient due to poor sleep quality, chronic allostatic load responses and dysregulated immune and inflammatory processes are further activated. Therefore, it can be hypothesized that the combined presence of high stress and poor sleep quality may have a more pronounced detrimental effect on the periodontium than either factor alone.
However, inconsistent and conflicting findings have been reported between relationship of stress, sleep quality, and bruxism as a result, highlighting the need for integrated evaluation of these factors within dental research.
In the context of bruxism, occlusal trauma is significant because the repetitive nature of occlusal loading may potentiate periodontal tissue destruction beyond the effects of microbial plaque alone.
Given the multifactorial nature of bruxism and periodontal disease, understanding how psychological (stress), psychological and behavioral (sleep quality), and mechanical (occlusal trauma) factors influence periodontal health in bruxers could enhance diagnostic precision and therapeutic strategies. This study aims to evaluate these relationships to clarify their impact on periodontal status.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Shubham Singh Kaur, BDS
- Número de teléfono: +91 8168143428
- Correo electrónico: kaurqismat1511@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Rajinder Kumar Sharma, MDS
- Número de teléfono: +91 9416358222
- Correo electrónico: rksharmamds@yahoo.in
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
Test Group:
- Adults aged 30-45 years
- Patients diagnosed with periodontitis according to the 2017 World Workshop classification of periodontal and peri-implant diseases and conditions.
- Patients who are probable bruxers according to BRUXSCREEN-Q
- Minimum of 20 natural teeth
Control Group:
- Adults aged 30-45 years
- Patients diagnosed with periodontitis according to the 2017 World Workshop classification of periodontal and peri-implant diseases and conditions.
- Patients who are not probable bruxers according to BRUXSCREEN-Q
- Minimum of 20 natural teeth
Exclusion Criteria:
- Systemic conditions affecting periodontium (e.g., diabetes, auto immune disorders)
- History of drugs having the potential impact on periodontal status like phenytoin, cyclosporin, calcium-channel blockers or antidepressant drugs
- Patients with pulpal pathology
- Pregnant or lactating females
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
probable bruxers according to bruxscreen-q with periodontitis
Periodontal parameters will be assessed which include clinical attachment level (CAL), periodontal pocket depth (PPD), bleeding on probing (BOP), Gingival index (GI), Tooth mobility will be assessed using a modified Lindhe and Nyman(1975) degree classification.
Stress level will be assessed by HADS 14, DASS 21, Sleep quality will be assessed with PSQI
|
these scale were assessed using questionnaires in both the groups
Otros nombres:
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|
patient who are non bruxers according to bruxscreen-q
Periodontal parameters will be assessed which include clinical attachment level (CAL), periodontal pocket depth (PPD), bleeding on probing (BOP), Gingival index (GI), Tooth mobility will be assessed using a modified Lindhe and Nyman(1975) degree classification.
Stress level will be assessed by HADS 14, DASS 21, Sleep quality will be assessed with PSQI
|
these scale were assessed using questionnaires in both the groups
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pittsburgh Sleep Quality Index (PSQI)
Periodo de tiempo: baseline
|
The Pittsburgh Sleep Quality Index (PSQI) will be used to assess sleep quality in both groups.
The PSQI is a self-reported questionnaire that measures sleep quality and disturbances over a 1-month time interval.
It yields a global score ranging from a minimum of 0 to a maximum of 21, where higher scores indicate worse sleep quality (a score greater than 5 indicates severe difficulties in at least two areas, or moderate difficulties in more than three areas).
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baseline
|
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Depression Anxiety Stress Scales - 21
Periodo de tiempo: baseline
|
The Depression Anxiety Stress Scales - 21 (DASS-21) will be used to assess psychological distress levels among both groups.
It is a 21-item self-report questionnaire designed to measure the negative emotional states across three distinct subscale: depression, anxiety, and stress.
Each subscale range from a minimum of 0 to a maximum of 42, where a lesser number indicates normal emotional state and a higher number signifies a increased severity of psychological distress.
Clinically, lower scores falling within the ranges of 0-9 for Depression, 0-7 for Anxiety, and 0-14 for Stress designate a "Normal" status.For Depression, scores progress through Mild (10-13), Moderate (14-20), Severe (21-27), and Extremely Severe (28+) bands.
For Anxiety, elevated scores represent Mild (8-9), Moderate (10-14), Severe (15-19), and Extremely Severe (20+) levels.
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baseline
|
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Hospital Anxiety and Depression Scale - 14
Periodo de tiempo: baseline
|
The Hospital Anxiety and Depression Scale (HADS) will be used to assess psychological distress levels among both groups.
The HADS is a 14-item self-report rating scale containing two distinct 7-item subscales: one for anxiety (HADS-A) and one for depression (HADS-D).
For each subscale, final scores range from a minimum of 0 to a maximum of 21, where a lesser number indicates a better outcome (absence of distress) and a higher number signifies a worse outcome (increased severity of anxiety or depressive symptoms).
Clinically, scores on either subscale are categorized into specific bands to interpret severity: a lower score between 0-7 represents a "Normal" or non-case state, whereas higher scores indicate elevated distress progression across Mild/Borderline abnormal (8-10), Moderate/Abnormal (11-14), and Severe/Severe abnormal (15-21) brackets.
|
baseline
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Rajinder Kumar Sharma, MDS, Post Graduate Institute Of Dental Sciences, Rohtak
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades periodontales
- Enfermedades de la Boca
- Enfermedades Estomatognáticas
- Enfermedades del Sistema Nervioso
- Desordenes mentales
- Enfermedades de los dientes
- Trastornos del sueño y la vigilia
- Trastornos del Sueño Intrínsecos
- Disomnias
- Comportamiento
- Hábitos
- Periodontitis
- Bruxismo
- Trastornos de iniciación y mantenimiento del sueño
Otros números de identificación del estudio
- Shubham Singh perio 26/56
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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