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Fractal Analysis Method in Periodontal Disease

Primary Purpose

Periodontal Diseases

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
fractal analysis
Sponsored by
Necmettin Erbakan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Periodontal Diseases focused on measuring Digital Radiography, Fractal Analysis, Periodontitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Necmettin Erbakan University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

periodontally healthy individuals

Stage 1 periodontitis

Stage 2 periodontitis

Stage 3 periodontitis

Arm Description

50 subject without any periodontal disease

50 subject diagnosed with stage 1 in the periodontal disease classification

50 subject diagnosed with stage 2 in the periodontal disease classification

50 subject diagnosed with stage 3 in the periodontal disease classification

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
November 26, 2022
Last Updated
December 6, 2022
Sponsor
Necmettin Erbakan University
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1. Study Identification

Unique Protocol Identification Number
NCT05639582
Brief Title
Fractal Analysis Method in Periodontal Disease
Official Title
Evaluation of Trabecular Bone Changes in Individuals With Periodontal Disease Using Fractal Analysis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
November 5, 2020 (Actual)
Primary Completion Date
May 5, 2021 (Actual)
Study Completion Date
November 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Necmettin Erbakan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases
Keywords
Digital Radiography, Fractal Analysis, Periodontitis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
periodontally healthy individuals
Arm Type
Experimental
Arm Description
50 subject without any periodontal disease
Arm Title
Stage 1 periodontitis
Arm Type
Experimental
Arm Description
50 subject diagnosed with stage 1 in the periodontal disease classification
Arm Title
Stage 2 periodontitis
Arm Type
Experimental
Arm Description
50 subject diagnosed with stage 2 in the periodontal disease classification
Arm Title
Stage 3 periodontitis
Arm Type
Experimental
Arm Description
50 subject diagnosed with stage 3 in the periodontal disease classification
Intervention Type
Other
Intervention Name(s)
fractal analysis
Intervention Description
fractal analysis is a method that numerically expresses bone changes.
Primary Outcome Measure Information:
Title
Evaluation of the effect of periodontal disease on alveolar bone by fractal analysis
Description
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.
Time Frame
baseline
Secondary Outcome Measure Information:
Title
Probing pocket depth
Description
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.
Time Frame
baseline
Title
gingival index
Description
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.
Time Frame
baseline
Title
plaque index
Description
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.
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Necmettin Erbakan University
City
Konya
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Fractal Analysis Method in Periodontal Disease

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