Relationship Between Malocclusion Severity and Periodontitis Risk

NCT ID: NCT07127744

Last Updated: 2025-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-15

Study Completion Date

2026-01-19

Brief Summary

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The goal of this observational study is to examine the potential relationship between the severity of orthodontic malocclusion and the risk of developing periodontitis in individuals by evaluating salivary and gingival crevicular levels of RANKL, osteoprotegerin (OPG), and oxidative stress biomarkers.

The main question it aims to answer is:

Does increasing severity of orthodontic malocclusion contribute to a higher risk of periodontitis through changes in RANKL/OPG balance and oxidative stress levels?

Participants with different levels of tooth misalignment (malocclusion) will be examined to assess the condition of their teeth and gums. During this examination, information such as dental plaque, gum bleeding, and the depth of gum pockets will be recorded. In addition, fluid samples collected from the gums will be tested in the laboratory to measure certain biological substances and chemical markers related to the body's balance between harmful and protective effects. These measurements will be done using special laboratory tests.

Detailed Description

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The aim of this study is to evaluate the potential relationship between the severity of orthodontic malocclusion and the risk of developing periodontitis through the analysis of RANKL, osteoprotegerin (OPG), and oxidative stress biomarkers. The mechanical effects of malocclusion on teeth and surrounding tissues may lead to inflammation and tissue destruction within the periodontal structures. Understanding the biomolecular mechanisms involved in this process is essential for early diagnosis and preventive approaches.

This cross-sectional study will include individuals with varying degrees of malocclusion severity. Orthodontic status will be determined through clinical evaluation and standardized indices, while periodontal status will be assessed using parameters such as the plaque index, papillary bleeding index, and probing pocket depth. In addition, gingival crevicular fluid (GCF) samples will be collected from participants to measure levels of RANKL, OPG, total antioxidant capacity (TAC), and total oxidative status (TOS) using the ELISA method.

The data obtained will help reveal whether orthodontic abnormalities increase the risk of periodontal disease and how this risk correlates with biomarker levels. The study emphasizes the importance of a holistic evaluation of both orthodontic and periodontal health.

Conditions

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Malocclusion

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients with normal or minor malocclusion

Patients with a Dental Aesthetic Index Score of ≤25

No interventions assigned to this group

Moderate malocclusion

Patients with a Dental Aesthetic Index Score of 26-30

No interventions assigned to this group

Severe malocclusion

Patients with a Dental Aesthetic Index Score of 31-35

No interventions assigned to this group

Obstructive malocclusion

Patients with a Dental Aesthetic Index Score ≥ 36

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients between the ages of 12 and 18,
* Patients with all permanent teeth,
* Not having taken antibiotics, steroids, and/or nonsteroidal anti-inflammatory drugs in the last 3 weeks,
* Not having an active infectious disease,
* Not having chronic medication use that affects periodontal tissues (cyclosporine A, Phenytoin),
* Not having taken antioxidant supplements in the last 6 months.

Exclusion Criteria

* Presence of any congenital craniofacial deformity (cleft lip and palate or any other craniofacial syndrome or deformity),
* Patients who have previously started or completed orthodontic treatment,
* Patients who have received periodontal treatment in the last 6 months,
* Acute illness,
* Systemic illness, mental illness, immunosuppressive medications, or immunodeficiency.
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Recep Tayyip Erdogan University Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dilek KARADOĞAN

Assoc. Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Periodontology of the Faculty of Dentistry of Recep Tayyip Erdogan University

Rize, Rize Province, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Oguz KOSE, Professor Dr.

Role: CONTACT

+90 541 348 64 65

Facility Contacts

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RTEU Faculty of Dentistry, Department of Periodontology

Role: primary

+90 464 222 00 00

Other Identifiers

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periortho05/2025

Identifier Type: -

Identifier Source: org_study_id

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