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Not yet recruiting NCT07127744

Relationship Between Malocclusion Severity and Periodontitis Risk

— Observational Malocclusion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Malocclusion. Basic parameters: 12 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Determination of the Relationship Between Orthodontic Malocclusion Severity and Periodontitis Risk Using RANKL, OPG and Oxidative Stress Markers

Overview

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

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.

Primary outcome measures

  • Gingival crevicular fluid collection [Time frame: Day 1]
  • Clinical Periodontal Parameters (Plaque Index) [Time frame: Day 1]
  • Periodontal Clinical Parametres (Papillary Bleeding Index) [Time frame: Day 1]
  • Periodontal Clinical Parametres (Bleeding on Probing Index) [Time frame: Day 1]
  • Periodontal Clinical Parametres (Probing Pocket Depth) [Time frame: Day 1]
  • Periodontal Clinical Parametres (Clinical Attachment Loss) [Time frame: Day 1]
Secondary outcome measures (1)
  • Determination of RANKL, OPG, TAS and TAC by ELISA [Time frame: 4th month]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Turkey (Türkiye) · 1 center
  • Department of Periodontology of the Faculty of Dentistry of Recep Tayyip Erdogan Universit — Rize

Identifiers

NCT: NCT07127744 · periortho05/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗