- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Kontakty i lokalizacje
Lokalizacje studiów
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-
Bilecik
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Bilecik, Bilecik, Turcja (Türkiye), 11100
- Bilecik Seyh Edebali University Faculty of Dentistry
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
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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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Presence of Non-Carious Cervical Lesions
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Keratinized Tissue Width
Ramy czasowe: At baseline / single clinical examination
|
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
Ramy czasowe: 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
Ramy czasowe: At baseline / single assessment
|
Oral hygiene habits including toothbrushing frequency, toothbrush type, brushing technique, and brushing force will be assessed using a structured questionnaire.
|
At baseline / single assessment
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Współpracownicy i badacze
Współpracownicy
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 29759
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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