Fractal Analysis Method in Periodontal Disease

Periodontal Diseases Clinical Trial

Official title:

Evaluation of Trabecular Bone Changes in Individuals With Periodontal Disease Using Fractal Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05639582
• Other study ID #: Ummuhantekinatay
• Status: Completed
• Phase: N/A
• Start date: November 5, 2020
• Est. completion date: November 5, 2021

Study information

• Verified date: December 2022
• Source: Necmettin Erbakan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, the effects of periodontal disease on alveolar bone were investigated using fractal analysis method.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 5, 2021
• Est. primary completion date: May 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Periodontal Diseases

Intervention

Other:
• fractal analysis
fractal analysis is a method that numerically expresses bone changes.

Locations

Country	Name	City	State
Turkey	Necmettin Erbakan University	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Necmettin Erbakan University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline
Secondary	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.	baseline
Secondary	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 Index(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.	baseline
Secondary	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.	baseline