Cone Beam Computed TomographyNCT06676358

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

An observational study of Cone Beam Computed Tomography and Periodontitis, run by Okan University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Cone Beam Computed Tomography, Periodontitis, Diagnosis of Bone Quality
Type of treatment: Injection or infusion
How many people: 90 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 15 Mar 2024to 30 Oct 2024
How long will I take part?: 1 Day
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

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)

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Okan Univercity
Istanbul, 34947

Other trials in Turkey (Türkiye)

About this study

Read the detailed description

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: Cone Beam Computed Tomography, Periodontitis, Diagnosis of Bone Quality, Diagnosis, Oral, Smoking, Cigarette
Keywords: cone beam computed tomography, Periodontitis, Diagnosis
Medical subject headings: Periodontitis, Disease, Cigarette Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06676358
Study group	Role	What they receive
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)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Baseline
Bone morphometric parameters
Trabecular Separation (Tb.Sp): Representing the mean distance between adjacent trabeculae, this parameter is also assessed using three-dimensional techniques.
Measured: Baseline
Bone morphometric parameters
Trabecular Thickness (Tb.Th): This parameter indicates the average thickness of the trabeculae, obtained through direct three-dimensional assessment methods.
Measured: Baseline

Secondary outcomes (5)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Mar 202430 Oct 2024

First posted6 Nov 2024
Study start15 Mar 2024
Primary completion14 Oct 2024
Study completion30 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Cone Beam Computed TomographyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Cross-sectional
Enrolment: 90 participants (actual)
Target duration: 1 Day

IDs, dates and publications

ClinicalTrials.gov ID: NCT06676358
Sponsor's protocol ID: 2024/178-23
Other IDs: 2024/178-23
Status last verified: Nov 2024
First submitted: 3 Nov 2024
Last updated: 6 Nov 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 41523571

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Effects of Smoking on Trabecular Bone Microarchitecture Using CBCT in Periodontal Disease
ClinicalTrials.gov ID: NCT06676358
Acronym / sponsor ID: 2024/178-23
Conditions: Cone Beam Computed Tomography, Periodontitis, Diagnosis of Bone Quality, Diagnosis, Oral, Smoking, Cigarette
Keywords: cone beam computed tomography, Periodontitis, Diagnosis
Study type: Observational
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: Okan UniversityUniversity, hospital or other
Study start: 15 Mar 2024 (actual)
Primary completion: 14 Oct 2024 (actual)
Study completion: 30 Oct 2024 (actual)
First posted: 6 Nov 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Other
Time perspective: Cross-sectional
Target follow-up: 1 Day
Number of arms: 6

Arm	Type	Receives
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)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
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)

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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.
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.
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.
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.

5 secondary outcomes

Clinical periodontal parameters
Time frame: Baseline
Clinical periodontal parameters
Time frame: Baseline
Clinical periodontal parameters
Time frame: Baseline
Clinical periodontal parameters
Time frame: Baseline
Clinical periodontal parameters
Time frame: Baseline

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
Derived from this study: PubMed 41523571Kayaalti 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Cone Beam Computed Tomography and Periodontitis, run by Okan University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bone morphometric parameters (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06676358, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2024.