Periodontal DiseasesNCT05639582
Fractal Analysis Method in Periodontal Disease
A study testing fractal analysis in people with Periodontal Diseases, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
In this study, the effects of periodontal disease on alveolar bone were investigated using fractal analysis method. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- fractal analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Nov 2020to 5 Nov 2021
- Phase
- Interventional
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-65 years old
- Getting a diagnosis of stage 1,2 and 3 periodontitis
- Be diagnosed as periodontally healthy
- Have no barriers to obtaining radiographs
- Not having any systemic disease that may affect periodontal status
- Not smoking and alcohol use
- Volunteer to participate in the study
Who cannot join
- Those who use drugs that can affect bone metabolism
- Radiographs with poor diagnostic quality
- Root canal treatment or teeth with periapical lesions in the area of interest
- Individuals who have suffered a fracture or trauma that affects the anatomy or integrity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Trabecular Bone Changes in Individuals With Periodontal Disease Using Fractal Analysis
In this study, the effects of periodontal disease on alveolar bone were investigated using fractal analysis method.
Read the detailed description
Background: It is very difficult to objectively evaluate the negative changes in bone structure due to periodontitis. The present study was aimed to evaluate the trabecular bone changes between healthy individuals and periodontitis patients by fractal dimension analysis on digital panoramic radiographs.
Method: The study included 50 periodontally healthy individuals (control group), 50 individuals with Stage 1 periodontitis (S1-P group), 50 individuals with Stage 2 periodontitis (S2-P), and 50 individuals with Stage 3 periodontitis (S3-P), a total of 200 individuals were included. The fractal dimension (FD) value of the trabecular bone in the interproximal space between mandibular first molar and second premolar tooth roots was evaluated using Image J program. The mean fractal dimension values of the two regions were calculated by box counting method.
- Conditions
- Periodontal Diseases
- Being tested
- fractal analysis
- Keywords
- Digital Radiography, Fractal Analysis, Periodontitis
- Medical subject headings
- Periodontal Diseases, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fractal analysisOther
fractal analysis is a method that numerically expresses bone changes.
| Study group | Role | What they receive |
|---|---|---|
| periodontally healthy individuals | Experimental | 50 subject without any periodontal disease Receives: Other: fractal analysis |
| Stage 1 periodontitis | Experimental | 50 subject diagnosed with stage 1 in the periodontal disease classification Receives: Other: fractal analysis |
| Stage 2 periodontitis | Experimental | 50 subject diagnosed with stage 2 in the periodontal disease classification Receives: Other: fractal analysis |
| Stage 3 periodontitis | Experimental | 50 subject diagnosed with stage 3 in the periodontal disease classification Receives: Other: fractal analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the effect of periodontal disease on alveolar bone by fractal analysis
Fractal dimension evaluation can give an objective result about the effect of periodontal disease on alveoler bone, since it shows changes in bone trabeculation numerically.
Measured: baseline
Secondary outcomes (3)
Probing pocket depth
Probing pocket depth(PPD) was measured for determining the severity of the disease and clinical outcome. High probing pocket depth shows more severe periodontal disease.
Measured: baseline
gingival index
The differences in gingival index scores between periodontally healthy and periodontitis.The gingival index was recorded for determining and classifying gingival status. The Gingival İndex(GI) scores each site on a 0 to 3 scale with 0 being normal and 3 being severe inflammation characterized by edema, redness, swelling and spontaneous bleeding.
Measured: baseline
plaque index
The differences in plaque index scores between periodontally healthy and periodontitis. Plaque index(PI) was recorded for determining and classifying oral hygiene status. The plaque index(PI) scores each site on a 0 to 3 scale with 0 being no plaque in the gingival area and 3 abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start5 Nov 2020
- Primary completion5 May 2021
- Study completion5 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ummuhan Tekin Atay, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05639582
- Sponsor's protocol ID
- Ummuhantekinatay
- Status last verified
- Dec 2022
- First submitted
- 26 Nov 2022
- Last updated
- 8 Dec 2022
- 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 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Trabecular Bone Changes in Individuals With Periodontal Disease Using Fractal Analysis
- ClinicalTrials.gov ID
- NCT05639582
- Acronym / sponsor ID
- Ummuhantekinatay
- Conditions
- Periodontal Diseases
- Keywords
- Digital Radiography, Fractal Analysis, Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 5 Nov 2020 (actual)
- Primary completion
- 5 May 2021 (actual)
- Study completion
- 5 Nov 2021 (actual)
- First posted
- 6 Dec 2022 (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.
In this study, the effects of periodontal disease on alveolar bone were investigated using fractal analysis method.
Detailed description
Background: It is very difficult to objectively evaluate the negative changes in bone structure due to periodontitis. The present study was aimed to evaluate the trabecular bone changes between healthy individuals and periodontitis patients by fractal dimension analysis on digital panoramic radiographs.
Method: The study included 50 periodontally healthy individuals (control group), 50 individuals with Stage 1 periodontitis (S1-P group), 50 individuals with Stage 2 periodontitis (S2-P), and 50 individuals with Stage 3 periodontitis (S3-P), a total of 200 individuals were included. The fractal dimension (FD) value of the trabecular bone in the interproximal space between mandibular first molar and second premolar tooth roots was evaluated using Image J program. The mean fractal dimension values of the two regions were calculated by box counting method.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| periodontally healthy individuals | Experimental | Other: fractal analysis50 subject without any periodontal disease |
| Stage 1 periodontitis | Experimental | Other: fractal analysis50 subject diagnosed with stage 1 in the periodontal disease classification |
| Stage 2 periodontitis | Experimental | Other: fractal analysis50 subject diagnosed with stage 2 in the periodontal disease classification |
| Stage 3 periodontitis | Experimental | Other: fractal analysis50 subject diagnosed with stage 3 in the periodontal disease classification |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18-65 years old
- Getting a diagnosis of stage 1,2 and 3 periodontitis
- Be diagnosed as periodontally healthy
- Have no barriers to obtaining radiographs
- Not having any systemic disease that may affect periodontal status
Key exclusion criteria (4 listed)
- Those who use drugs that can affect bone metabolism
- Radiographs with poor diagnostic quality
- Root canal treatment or teeth with periapical lesions in the area of interest
- Individuals who have suffered a fracture or trauma that affects the anatomy or integrity
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 |
|---|---|---|
| fractal analysisfractal analysis is a method that numerically expresses bone changes. | Other | Stage 1 periodontitis, Stage 2 periodontitis, Stage 3 periodontitis, periodontally healthy individuals |
Primary outcome
Evaluation of the effect of periodontal disease on alveolar bone by fractal analysis
Time frame: baseline
Fractal dimension evaluation can give an objective result about the effect of periodontal disease on alveoler bone, since it shows changes in bone trabeculation numerically.
3 secondary outcomes
Probing pocket depth
Time frame: baseline
gingival index
Time frame: baseline
plaque index
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 8 Dec 2022.
- 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?
A study testing fractal analysis in people with Periodontal Diseases, run by Necmettin Erbakan 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 4 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 8 Dec 2022. 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?
Evaluation of the effect of periodontal disease on alveolar bone by fractal analysis (time frame: baseline). 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 8 Dec 2022.