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

NCT06676358 | Completed

• 1 other identifier: 2024/178-23
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

cone beam computed tomography; Periodontitis; Diagnosis

Outcome Measures

Primary Outcomes (4)

• Bone morphometric parameters

  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.

  Baseline

• Bone morphometric parameters

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

  Baseline

• Bone morphometric parameters

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

  Baseline

• Bone morphometric parameters

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

  Baseline

Secondary Outcomes (5)

• Clinical periodontal parameters

  Baseline

• Clinical periodontal parameters

  Baseline

• Clinical periodontal parameters

  Baseline

• Clinical periodontal parameters

  Baseline

• Clinical periodontal parameters

  Baseline

Study Arms (6)

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.

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.

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.)

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).

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)

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A sample size of 15 patients per group (6 groups, total 90 patients) was calculated using the G\*Power 3.1.9.2 software (power \[1-β\] = 0.80, alpha level \[α\] = 0.05, effect size \[f\] = 0.4)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Okan University: lead

Study Sites (1)

Okan Univercity

Istanbul, 34947, Turkey (Türkiye)

Location

Related Publications (1)

• Kayaalti Yuksek S, Buyuk C, Cebeci I, Cayir Keles G. Evaluation of the Effects of Smoking on Trabecular Bone Microarchitecture Using Cone-Beam Computed Tomography in Periodontal Disease. Cureus. 2025 Dec 9;17(12):e98851. doi: 10.7759/cureus.98851. eCollection 2025 Dec.

  PMID: 41523571 DERIVED

MeSH Terms

Conditions

Periodontitis; Disease; Cigarette Smoking

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tobacco Smoking; Smoking; Behavior; Tobacco Use

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof

Study Record Dates

• First Submitted: November 3, 2024
• First Posted: November 6, 2024
• Study Start: March 15, 2024
• Primary Completion: October 14, 2024
• Study Completion: October 30, 2024
• Last Updated: November 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)