- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Bilecik
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Bilecik, Bilecik, Turkey (Türkiye), 11100
- Bilecik Seyh Edebali University Faculty of Dentistry
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
NCCL Present
Participants presenting with non-carious cervical lesions on the maxillary first premolar tooth during clinical examination.
|
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.
|
|
NCCL Absent
Participants without non-carious cervical lesions on the maxillary first premolar tooth during clinical examination.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Presence of Non-Carious Cervical Lesions
Time Frame: At baseline / single clinical examination
|
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.
|
At baseline / single clinical examination
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Keratinized Tissue Width
Time Frame: 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.
|
At baseline / single clinical examination
|
|
Gingival Phenotype
Time Frame: At baseline / single clinical examination
|
Gingival phenotype will be evaluated using periodontal probe transparency and classified as thin or thick phenotype.
|
At baseline / single clinical examination
|
|
Oral Hygiene Habits
Time Frame: 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
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 29759
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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