PeriodontitisNCT07904455
Trabecular Bone Changes After Periodontal Treatment in Patients With and Without Bruxism
An observational study of Periodontitis and Bruxism, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational cohort study evaluated changes in the trabecular bone structure around teeth after nonsurgical periodontal treatment in patients with periodontitis, with and without bruxism. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis, Bruxism
- What is being tested?
- Bruxism Status
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 May 2025to 18 May 2026
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adults with Stage II-III, Grade B periodontitis who presented to the Department of Periodontology, Faculty of Dentistry, Hatay Mustafa Kemal University and met the predefined eligibility criteria were enrolled. Participants were classified according to the presence or absence of probable bruxism and were prospectively followed for six months after nonsurgical periodontal treatment.
Who may be able to join
- Individuals diagnosed with periodontitis according to the criteria of the 2017 Classification of Periodontal and Peri-Implant Diseases and Conditions
- Patients who had not received any periodontal treatment within the preceding six months
- Individuals older than 18 years
- Individuals with Angle Class I occlusion
- Individuals without missing teeth in the posterior region that could compromise the occlusal relationship
- Participants who provided written informed consent and voluntarily agreed to take part in the study
Who cannot join
- Patients with systemic diseases or conditions such as diabetes, cancer, HIV/AIDS, acute infections, hepatic or renal failure/dysfunction, or autoimmune disorders
- Pregnant women
- Individuals regularly using nonsteroidal anti-inflammatory drugs, glucocorticoids, bisphosphonates, or denosumab (an anti-RANKL monoclonal antibody)
- Individuals with diseases affecting bone metabolism, such as osteoporosis or ankylosing spondylitis
- Individuals with prosthetic restorations or extensive fillings, premature occlusal contacts caused by restorations, or severe malocclusion
- Individuals with endodontically treated teeth
Show all 9Show fewer
- Individuals with temporomandibular joint disorders
- Individuals with psychiatric disorders who were using psychotropic medications
- Individuals with alcohol or substance dependence
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hatay Mustafa Kemal University Faculty of Dentistry
Hatay, ANTAKYA
About this study
Official title: Comparative Evaluation of Trabecular Bone Structure Using Fractal Analysis in Periodontitis Patients With and Without Bruxism Following Periodontal Treatment: A Prospective Cohort Study
This prospective observational cohort study evaluated changes in the trabecular bone structure around teeth after nonsurgical periodontal treatment in patients with periodontitis, with and without bruxism. Fractal dimension was measured on standardized periapical radiographs taken at baseline and six months after treatment. Clinical periodontal measurements were also recorded at both time points. The main objective was to determine whether changes in fractal dimension after periodontal treatment differed between patients with and without bruxism.
- Conditions
- Periodontitis, Bruxism
- Being tested
- Bruxism Status
- Keywords
- Periodontitis, Bruxism, Fractal analysis
- Medical subject headings
- Periodontitis, Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bruxism StatusOther
Participants were classified according to the presence or absence of probable bruxism based on self-reported information and clinical examination findings using predefined study criteria. Sleep and awake bruxism were not assessed separately, and no instrument-based assessment was performed. Bruxism status was observed and was not assigned by the investigators.
| Study group | Role | What they receive |
|---|---|---|
| Periodontitis With Bruxism | Patients with Stage II-III, Grade B periodontitis who met the predefined study criteria for bruxism and were followed for six months after nonsurgical periodontal treatment. Receives: Other: Bruxism Status | |
| Periodontitis Without Bruxism | Patients with Stage II-III, Grade B periodontitis who did not meet the predefined study criteria for bruxism and were followed for six months after nonsurgical periodontal treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Alveolar Trabecular Bone Fractal Dimension
Fractal dimension was calculated from standardized periapical radiographs of the mandibular first molar region using the box-counting method in ImageJ. The change in fractal dimension from baseline to six months after nonsurgical periodontal treatment was evaluated and compared between patients with and without bruxism.
Measured: Baseline to 6 months
Secondary outcomes (5)
Change in Plaque Index
Plaque index was recorded at baseline and six months after nonsurgical periodontal treatment, and the change over time was evaluated.
Measured: Baseline to 6 months
Change in Gingival Index
Gingival index was recorded at baseline and six months after nonsurgical periodontal treatment, and the change over time was evaluated.
Measured: Baseline to 6 months
Change in Bleeding on Probing
Bleeding on probing was recorded as a percentage at baseline and six months after nonsurgical periodontal treatment, and the change over time was evaluated.
Measured: Baseline to 6 months
Change in Probing Pocket Depth
Probing pocket depth was measured in millimeters at baseline and six months after nonsurgical periodontal treatment, and the change over time was evaluated.
Measured: Baseline to 6 months
Change in Clinical Attachment Level
Clinical attachment level was measured in millimeters at baseline and six months after nonsurgical periodontal treatment, and the change over time was evaluated.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start5 May 2025
- Primary completion29 Apr 2026
- Study completion18 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mustafa Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halil Ibrahim SIK, Mustafa Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07904455
- Sponsor's protocol ID
- 25.DHU.003
- Other IDs
- 25.DHU.003
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Trabecular Bone Structure Using Fractal Analysis in Periodontitis Patients With and Without Bruxism Following Periodontal Treatment: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07904455
- Acronym / sponsor ID
- 25.DHU.003
- Conditions
- Periodontitis, Bruxism
- Keywords
- Periodontitis, Bruxism, Fractal analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Mustafa Kemal UniversityUniversity, hospital or other
- Study start
- 5 May 2025 (actual)
- Primary completion
- 29 Apr 2026 (actual)
- Study completion
- 18 May 2026 (actual)
- First posted
- 29 Oct 2026 (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.
This prospective observational cohort study evaluated changes in the trabecular bone structure around teeth after nonsurgical periodontal treatment in patients with periodontitis, with and without bruxism. Fractal dimension was measured on standardized periapical radiographs taken at baseline and six months after treatment. Clinical periodontal measurements were also recorded at both time points. The main objective was to determine whether changes in fractal dimension after periodontal treatment differed between patients with and without bruxism.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Periodontitis With Bruxism | – | Other: Bruxism StatusPatients with Stage II-III, Grade B periodontitis who met the predefined study criteria for bruxism and were followed for six months after nonsurgical periodontal treatment. |
| Periodontitis Without Bruxism | – | –Patients with Stage II-III, Grade B periodontitis who did not meet the predefined study criteria for bruxism and were followed for six months after nonsurgical periodontal treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with Stage II-III, Grade B periodontitis who presented to the Department of Periodontology, Faculty of Dentistry, Hatay Mustafa Kemal University and met the predefined eligibility criteria were enrolled. Participants were classified according to the presence or absence of probable bruxism and were prospectively followed for six months after nonsurgical periodontal treatment.
Key inclusion criteria (6 listed)
- Individuals diagnosed with periodontitis according to the criteria of the 2017 Classification of Periodontal and Peri-Implant Diseases and Conditions
- Patients who had not received any periodontal treatment within the preceding six months
- Individuals older than 18 years
- Individuals with Angle Class I occlusion
- Individuals without missing teeth in the posterior region that could compromise the occlusal relationship
Key exclusion criteria (9 listed)
- Patients with systemic diseases or conditions such as diabetes, cancer, HIV/AIDS, acute infections, hepatic or renal failure/dysfunction, or autoimmune disorders
- Pregnant women
- Individuals regularly using nonsteroidal anti-inflammatory drugs, glucocorticoids, bisphosphonates, or denosumab (an anti-RANKL monoclonal antibody)
- Individuals with diseases affecting bone metabolism, such as osteoporosis or ankylosing spondylitis
- Individuals with prosthetic restorations or extensive fillings, premature occlusal contacts caused by restorations, or severe malocclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bruxism StatusParticipants were classified according to the presence or absence of probable bruxism based on self-reported information and clinical examination findings using predefined study criteria. Sleep and awake bruxism were not assessed separately, and no instrument-based assessment was performed. Bruxism status was observed and was not assigned by the investigators. | Other | Periodontitis With Bruxism |
Primary outcome
Change in Alveolar Trabecular Bone Fractal Dimension
Time frame: Baseline to 6 months
Fractal dimension was calculated from standardized periapical radiographs of the mandibular first molar region using the box-counting method in ImageJ. The change in fractal dimension from baseline to six months after nonsurgical periodontal treatment was evaluated and compared between patients with and without bruxism.
5 secondary outcomes
Change in Plaque Index
Time frame: Baseline to 6 months
Change in Gingival Index
Time frame: Baseline to 6 months
Change in Bleeding on Probing
Time frame: Baseline to 6 months
Change in Probing Pocket Depth
Time frame: Baseline to 6 months
Change in Clinical Attachment Level
Time frame: Baseline to 6 months
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 29 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Periodontitis
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
Probiotics, Antibiotics
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel
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 Periodontitis and Bruxism, run by Mustafa Kemal 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 6 inclusion and 9 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 29 Oct 2026. 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?
Change in Alveolar Trabecular Bone Fractal Dimension (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Oct 2026.