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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07629492
Association Between Periodontal Morphology and Non-Carious Cervical Lesions (NCCL-PM)
Relationship Between Periodontal Morphology, Oral Habits, and Non-Carious Cervical Lesions: A Cross-Sectional Observational Study
This observational study aims to investigate the relationship between periodontal morphology, oral hygiene habits, and non-carious cervical lesions (NCCLs) in adults aged 18-65 years. The main questions it aims to answer are:
Is there an association between periodontal soft tissue characteristics and the presence of NCCLs? Are oral hygiene habits and parafunctional behaviors associated with NCCLs?
Participants will:
Complete a structured questionnaire about oral hygiene habits and oral behaviors Undergo a clinical periodontal examination including assessment of plaque index, gingival index, probing depth, gingival recession, keratinized tissue width, gingival phenotype, and NCCL presence on the maxillary first premolar tooth
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Periodontal morphology and oral hygiene behaviors may play an important role in the development of non-carious cervical lesions (NCCLs), which are characterized by the loss of dental hard tissue at the cervical region of the tooth without the presence of dental caries. NCCLs are considered multifactorial conditions associated with mechanical stress, toothbrushing habits, parafunctional behaviors, and periodontal soft tissue characteristics.
This cross-sectional observational study is designed to investigate the relationship between periodontal morphology, oral hygiene habits, and the presence of NCCLs in adults aged 18-65 years attending the Faculty of Dentistry of Necmettin Erbakan University. A total of 180 participants are planned to be included.
Clinical periodontal examination will be performed on the maxillary first premolar tooth. The evaluated parameters will include probing depth, gingival recession, clinical attachment level, keratinized tissue width, gingival phenotype, plaque index, gingival index, dentin hypersensitivity, and the presence of NCCLs. Tooth position and parafunctional habits associated with occlusal stress will also be recorded.
Participants will complete a structured questionnaire regarding demographic characteristics, oral hygiene practices, toothbrushing frequency and technique, toothbrush type, brushing force, and oral habits.
The primary objective of the study is to determine whether periodontal soft tissue characteristics and oral hygiene-related behaviors are associated with the presence of NCCLs. Statistical analyses will include descriptive statistics, group comparisons, and multivariable logistic regression analyses to identify factors independently associated with NCCLs.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Bilecik
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Bilecik, Bilecik, Turquía (Türkiye), 11100
- Bilecik Seyh Edebali University Faculty of Dentistry
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Adults aged between 18 and 65 years
- Presence of the maxillary first premolar tooth in the oral cavity
- Presence of at least 20 natural teeth
- Periodontally stable individuals without generalized active periodontal destruction
- Systemically healthy individuals or individuals with controlled systemic diseases
- Individuals who voluntarily agree to participate and provide informed consent
Exclusion Criteria:
- Presence of extensive restoration, caries, endodontic treatment, cervical restoration, crown/bridge restoration, orthodontic brackets, or retainers on the maxillary first premolar tooth
- Missing posterior teeth or edentulous posterior segments
- Ongoing orthodontic treatment
- Severe bruxism or use of occlusal splints/night guards
- Gastroesophageal reflux disease or bulimia nervosa
- Frequent acidic beverage consumption
- Smoking ≥5 cigarettes per day
- Pregnancy or lactation
- Individuals unable to comply with the clinical examination procedures
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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NCCL Present
Participants presenting with non-carious cervical lesions on the maxillary first premolar tooth during clinical examination.
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Clinical periodontal examination and questionnaire-based assessment will be performed to evaluate periodontal morphology, oral hygiene habits, and the presence of non-carious cervical lesions (NCCLs).
Clinical parameters including probing depth, gingival recession, clinical attachment level, keratinized tissue width, gingival phenotype, plaque index, gingival index, dentin hypersensitivity, and tooth position will be recorded on the maxillary first premolar tooth.
Participants will also complete a structured questionnaire regarding oral hygiene behaviors, toothbrushing habits, and parafunctional activities.
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NCCL Absent
Participants without non-carious cervical lesions on the maxillary first premolar tooth during clinical examination.
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Clinical periodontal examination and questionnaire-based assessment will be performed to evaluate periodontal morphology, oral hygiene habits, and the presence of non-carious cervical lesions (NCCLs).
Clinical parameters including probing depth, gingival recession, clinical attachment level, keratinized tissue width, gingival phenotype, plaque index, gingival index, dentin hypersensitivity, and tooth position will be recorded on the maxillary first premolar tooth.
Participants will also complete a structured questionnaire regarding oral hygiene behaviors, toothbrushing habits, and parafunctional activities.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Presence of Non-Carious Cervical Lesions
Periodo de tiempo: At baseline / single clinical examination
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The presence or absence of non-carious cervical lesions on the maxillary first premolar tooth will be assessed by clinical examination.
NCCL will be recorded as a binary outcome: present or absent.
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At baseline / single clinical examination
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Keratinized Tissue Width
Periodo de tiempo: At baseline / single clinical examination
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Keratinized tissue width will be measured in millimeters from the free gingival margin to the mucogingival junction at the mid-buccal aspect of the maxillary first premolar tooth.
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At baseline / single clinical examination
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Gingival Phenotype
Periodo de tiempo: At baseline / single clinical examination
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Gingival phenotype will be evaluated using periodontal probe transparency and classified as thin or thick phenotype.
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At baseline / single clinical examination
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Oral Hygiene Habits
Periodo de tiempo: At baseline / single assessment
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Oral hygiene habits including toothbrushing frequency, toothbrush type, brushing technique, and brushing force will be assessed using a structured questionnaire.
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At baseline / single assessment
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Otros números de identificación del estudio
- 29759
Plan de datos de participantes individuales (IPD)
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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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