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Completed

NCT Number: NCT06676358

Evaluation of the Effects of Smoking on Trabecular Bone Microarchitecture Using CBCT in Periodontal Disease

The purpose of this cross-sectional study is to evaluate the morphometric properties of trabecular bone quality using Cone-beam computed tomography in periodontal disease at different stages, comparing smokers and non-smokers.

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Key information

Conditions

Cone Beam Computed Tomography Behavior Cigarette Smoking Diagnosis of Bone Quality Diagnosis, Oral Disease Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Smoking Smoking, Cigarette Stomatognathic Diseases Tobacco Smoking Tobacco Use

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Okan Univercity

Istanbul, 34947, Turkey (Türkiye)

About this study

This cross-sectional study aimed to analyze changes in trabecular bone quality associated with smoking inindividuals with periodontal disease using morphometric analysis of Cone Beam Computed Tomography (CBCT)images. Materials-Methods: The study involved 90 systemically healthy patients who were smokers (>=10cigarettes/day) or non-smokers, and were indicated for CBCT.Clinical periodontal parameters (plaque index, gingival index, probing pocket depth, bleeding on probing, clinicalattachment loss (CAL)) were recorded. Participants were divided into two main groups based on smoking statusand three subgroups based on periodontal diagnosis: gingivitis, Stage I-II periodontitis, and Stage III-IVperiodontitis (n=15). Mandibular first molars and central incisors without prosthetic restorations, endodonticlesions, or root canal treatments were included. Two volumetric regions of interest (ROIs) with dimensions of5x5x10 mm were selected around the apices of these teeth: posterior ROI and anterior ROI. Trabecular bonemicro-architecture was analyzed using the BoneJ plugin for morphometric parameters: anisotropy (DA), bonevolume fraction (BV/TV), trabecular thickness (Tb.Th), and trabecular separation (Tb.Sp). Statistical analysis wasperformed using Student's t-test, one-way ANOVA, and Kruskal-Wallis tests.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals aged 18 years or older who are systemically healthy.
  • Presence of mandibular molars and mandibular anterior teeth.
  • No pathologies affecting the alveolar bone.
  • No history of orthodontic treatment.
  • No use of medication that may impact bone health.
  • No history of radiation or chemotherapy treatment.
  • Selected mandibular molars and central incisors must be free of caries. Selected teeth must not have crowns, root canal treatments, or endodontic lesions.

Exclusion criteria

  • Patients who are exhibiting signs of occlusal trauma
  • Patients who are bruxism

Treatment and study plan

Primary outcomes

  1. Bone morphometric parameters

    Time frame: Baseline

    The microarchitecture of trabecular bone was analyzed by measuring bone morphometric parameters (BMPs) using the BoneJ plugin of the software.

    Degree of Anisotropy (DA): This parameter assesses the directional characteristics of trabecular bone. A DA value of 1 indicates an isotropic structure, while values above 1 indicate anisotropy. DA is calculated as the ratio of the longest mean intercept length vector to the shortest.

  2. Bone morphometric parameters

    Time frame: Baseline

    Bone Volume Fraction (BV/TV): Representing the ratio of bone volume to total volume within the ROI, BV/TV indicates bone density.

  3. Bone morphometric parameters

    Time frame: Baseline

    Trabecular Separation (Tb.Sp): Representing the mean distance between adjacent trabeculae, this parameter is also assessed using three-dimensional techniques.

  4. Bone morphometric parameters

    Time frame: Baseline

    Trabecular Thickness (Tb.Th): This parameter indicates the average thickness of the trabeculae, obtained through direct three-dimensional assessment methods.

Secondary outcomes

  1. Clinical periodontal parameters

    Time frame: Baseline

    A single calibrated operator (I.C.) performed the periodontal assessment utilizing an intraoral mirror and William's periodontal probe. Plaque Index (PI): The PI assesses the thickness of plaque along the gingival margin. After drying the teeth, the examiner visually inspects the surfaces of the teeth. Scores are assigned based on the presence and thickness of plaque on the gingival third of the tooth surface, usually on a scale from 0 (no plaque) to 3 (abundant plaque accumulation).

  2. Clinical periodontal parameters

    Time frame: Baseline

    Gingival Index (GI): The GI measures the severity of gingival inflammation. The gingiva around selected teeth is observed and gently probed to evaluate bleeding and inflammation. Scores range from 0 to 3, where 0 indicates healthy gingiva and 3 indicates severe inflammation with spontaneous bleeding.

  3. Clinical periodontal parameters

    Time frame: Baseline

    Periodontal Pocket Depth (PPD): PPD is measured by inserting a periodontal probe, like a William's probe, into the sulcus or pocket between the tooth and gum. The depth, in millimeters, is recorded for each probing site around the tooth to evaluate the extent of pocketing or detachment of the gingiva.

  4. Clinical periodontal parameters

    Time frame: Baseline

    Clinical Attachment Level (CAL): CAL assesses the extent of periodontal attachment loss. It's measured as the distance from the cemento-enamel junction (CEJ) to the base of the pocket or sulcus. By comparing this measurement over time, one can evaluate the progression of periodontal disease.

  5. Clinical periodontal parameters

    Time frame: Baseline

    Bleeding on Probing (BOP): BOP evaluates the presence of inflammation through bleeding. After probing the periodontal pocket, the site is observed for bleeding

Sponsors and collaborators

Lead sponsor

Okan University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 6, 2024
Registry last updated
Nov 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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