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

NCT ID: NCT06676358

Last Updated: 2024-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-15

Study Completion Date

2024-10-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cone Beam Computed Tomography Periodontitis Diagnosis of Bone Quality Diagnosis, Oral Smoking, Cigarette

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Group 1: Non-Smokers with gingivitis

Patients with no history of cigarette use were assigned to the non-smoking group. Gingivitis was diagnosed based on the presence of bleeding on probing in at least 10% of all assessed sites and the absence of attachment and bone loss.

No interventions assigned to this group

Group 2: Smokers with gingivitis

Smoking status was categorized as follows: patients in the smoking group were those who smoked more than ten cigarettes daily and had a smoking history exceeding five years. Gingivitis was diagnosed based on the presence of bleeding on probing in at least 10% of all assessed sites and the absence of attachment and bone loss.

No interventions assigned to this group

Group 3: Smokers with mild moderate periodontitis

Smoking status was categorized as follows: patients in the smoking group were those who smoked more than ten cigarettes daily and had a smoking history exceeding five years. The classification of periodontitis stages was primarily based on clinical attachment loss (CAL), radiographic bone loss, and tooth loss criteria. Specifically, CAL of 1-2 mm was classified as periodontitis stage I, 3-4 mm as stage II (mild moderate periodontitis.)

No interventions assigned to this group

Group 4: Non-Smokers with mild moderate periodontitis

Patients with no history of cigarette use were assigned to the non-smoking group. The classification of periodontitis stages was primarily based on clinical attachment loss (CAL). Specifically, CAL of 1-2 mm was classified as stage I, 3-4 mm as stage II (mild moderate periodontitis).

No interventions assigned to this group

Group 5: Smokers with severe periodontitis

Smoking status was categorized as follows: patients in the smoking group were those who smoked more than ten cigarettes daily and had a smoking history exceeding five years. Clinical attachment loss of 1-2 mm was classified as and ≥5 mm as stages III-IV. The criteria for tooth loss included up to four teeth lost for stage III, and five or more teeth lost due to periodontitis for stage IV (severe periodontitis)

No interventions assigned to this group

Group 6: Non-Smokers with severe periodontitis

Patients with no history of cigarette use were assigned to the non-smoking group. Clinical attachment loss of 1-2 mm was classified as and ≥5 mm as stages III-IV. The criteria for tooth loss included up to four teeth lost for stage III, and five or more teeth lost due to periodontitis for stage IV (severe periodontitis)

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Okan University

OTHER

Sponsor Role lead

Responsible Party

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Sibel Kayaalti-Yuksek

Assoc.Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Okan Univercity

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2024/178-23

Identifier Type: REGISTRY

Identifier Source: secondary_id

2024/178-23

Identifier Type: -

Identifier Source: org_study_id

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