Relationship Between Malocclusion Severity and Periodontitis Risk

NCT07127744 | Not Yet Recruiting DMC

• 1 other identifier: periortho05/2025
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malocclusion

Keywords

malocclusion; periodontitis; RANKL; Osteoprotegerin; oxidative stress

Outcome Measures

Primary Outcomes (6)

• Gingival crevicular fluid collection

  After isolating the teeth with a cotton roll, supragingival plaque will be removed and a gentle airflow will be used to dry the teeth. GCF samples will be collected by inserting PerioPaper strips into the mesiobuccal gingival sulcus to a depth of approximately 1 mm for 30 seconds. A calibrated Periotron 8000 instrument will then be used to measure the total GCF volume. PerioPaper strips will then be stored at -80°C for future measurements.

  Day 1

• Clinical Periodontal Parameters (Plaque Index)

  Plaque Index (PI) This index is used to evaluate the amount of dental plaque accumulation on tooth surfaces. Each tooth's four surfaces (buccal, lingual, mesial, distal) are examined using a probe or visually. Each surface is scored from 0 to 3. The average score is calculated for each tooth. The overall plaque index is obtained by averaging the scores from all examined teeth. Score Description 0 No plaque. 1. No visible plaque, but a slight film of plaque is detected when a probe is run along the gingival margin. 2. Visible plaque along the gingival margin, forming a continuous band. 3. Abundant plaque covering the gingival area and extending toward the middle of the tooth surface, including the interproximal spaces.

  Day 1

• Periodontal Clinical Parametres (Papillary Bleeding Index)

  Papillary Bleeding Index (PBI) This index is used to assess bleeding of the interdental papilla-an early sign of periodontal disease-in order to evaluate the degree of gingival inflammation. A periodontal probe is gently inserted into each interdental papilla (the triangular-shaped gum tissue between teeth). The probe is placed approximately 1-2 mm into the papilla and directed upward. Bleeding occurring within 10-30 seconds is observed and scored based on severity. The scores from all papillae are totaled and divided by the number of examined sites to obtain the average PBI score. Score Description 0 No bleeding 1. Single-point, slight bleeding 2. Thin line of blood 3. Obvious and rapid bleeding across the entire papilla, slight spreading 4. Severe, profuse bleeding that overflows the papilla, usually with evident inflammation

  Day 1

• Periodontal Clinical Parametres (Bleeding on Probing Index)

  Bleeding on Probing (BOP) Index This index is used to assess the presence and severity of gingival inflammation by observing bleeding after gentle pressure is applied to the gingival sulcus using a periodontal probe. A thin periodontal probe is gently inserted into the gingival sulcus with light pressure (approximately 20-25 grams). Bleeding occurring within 10-30 seconds is observed. Each measurement site is recorded as either "bleeding present" or "bleeding absent." Presence of bleeding is an early and sensitive indicator of gingival inflammation. Score Description 0 No bleeding 1 Bleeding present (mild or severe)

  Day 1

• Periodontal Clinical Parametres (Probing Pocket Depth)

  Probing Pocket Depth (PPD) Using a Williams periodontal probe, the distance between the marginal gingival margin and the base of the periodontal pocket is measured in millimeters at six sites per tooth: mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual. All teeth are measured. The values obtained from each site are summed and then divided by the total number of sites measured. This gives the average probing depth for the individual. Measurement Interpretation 1-3 mm Healthy sulcus 4-5 mm Shallow to moderate pocket ≥6 mm Deep periodontal pocket (advanced disease)

  Day 1

• Periodontal Clinical Parametres (Clinical Attachment Loss)

  Clinical Attachment Loss (CAL) Using a Williams periodontal probe, the distance between the enamel-cementum junction and the base of the periodontal pocket is measured in millimeters at six sites per tooth: mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual. All teeth are measured. The values obtained from each site are summed and then divided by the total number of sites measured. This gives the average probing depth for the individual. CAL Value Interpretation 0-1 mm Healthy / minimal loss 2-3 mm Mild attachment loss 4-5 mm Moderate attachment loss ≥6 mm Severe attachment loss

  Day 1

Secondary Outcomes (1)

• Determination of RANKL, OPG, TAS and TAC by ELISA

  4th month

Study Arms (4)

Patients with normal or minor malocclusion

Patients with a Dental Aesthetic Index Score of ≤25

Moderate malocclusion

Patients with a Dental Aesthetic Index Score of 26-30

Severe malocclusion

Patients with a Dental Aesthetic Index Score of 31-35

Obstructive malocclusion

Patients with a Dental Aesthetic Index Score ≥ 36

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients coming to the Periodontology Clinic of Recep Tayyip Erdoğan University Faculty of Dentistry for routine periodontal treatment

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Recep Tayyip Erdogan University Training and Research Hospital: lead

Study Sites (1)

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

Rize, Rize Province, 53200, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Gingival Crevicular Fluid (GCF) Collection After isolating the teeth with a cotton roll, supragingival plaque will be removed and a gentle airflow will be used to dry the teeth. GCF samples will be collected by inserting PerioPaper strips into the mesiobuccal gingival sulcus to a depth of approximately 1 mm for 30 seconds. A calibrated Periotron 8000 instrument will then be used to measure the total GCF volume. PerioPaper strips will then be stored at -80°C for future measurements.

MeSH Terms

Conditions

Malocclusion; Periodontitis

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases

Central Study Contacts

Oguz KOSE, Professor Dr.

CONTACT

+90 541 348 64 65; oguz.kose@erdogan.edu.tr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr.

Study Record Dates

• First Submitted: August 10, 2025
• First Posted: August 17, 2025
• Study Start: September 15, 2025
• Primary Completion: December 15, 2025
• Study Completion: January 19, 2026
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)