NCT05639582

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 5, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 26, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 6, 2022

Completed
Last Updated

December 8, 2022

Status Verified

December 1, 2022

Enrollment Period

6 months

First QC Date

November 26, 2022

Last Update Submit

December 6, 2022

Conditions

Keywords

Digital RadiographyFractal AnalysisPeriodontitis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Probing pocket depth

    baseline

  • gingival index

    baseline

  • plaque index

    baseline

Study Arms (4)

periodontally healthy individuals

EXPERIMENTAL

50 subject without any periodontal disease

Other: fractal analysis

Stage 1 periodontitis

EXPERIMENTAL

50 subject diagnosed with stage 1 in the periodontal disease classification

Other: fractal analysis

Stage 2 periodontitis

EXPERIMENTAL

50 subject diagnosed with stage 2 in the periodontal disease classification

Other: fractal analysis

Stage 3 periodontitis

EXPERIMENTAL

50 subject diagnosed with stage 3 in the periodontal disease classification

Other: fractal analysis

Interventions

fractal analysis is a method that numerically expresses bone changes.

Stage 1 periodontitisStage 2 periodontitisStage 3 periodontitisperiodontally healthy individuals

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necmettin Erbakan University

Konya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontal DiseasesPeriodontitis

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 26, 2022

First Posted

December 6, 2022

Study Start

November 5, 2020

Primary Completion

May 5, 2021

Study Completion

November 5, 2021

Last Updated

December 8, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations