Relationship Between Malocclusion Severity and Periodontitis Risk

ConditionMalocclusion
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12-18
SponsorRecep Tayyip Erdogan University Training and Research Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

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,

Trial population

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

Trial design

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

70 Participants
are grouped into 4 trial groups
Group A: Patients with normal or minor malocclusion
Group B: Moderate malocclusion
Group C: Severe malocclusion
Group D: Obstructive malocclusion

Trial outcomes

Primary outcomes

1

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.

Time frame
Day 1
2

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.

Time frame
Day 1
3

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

Time frame
Day 1
4

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)

Time frame
Day 1

Secondary outcomes

1

Determination of RANKL, OPG, TAS and TAC by ELISA

Frozen paper strips will be thawed and diluted with 200 μL of phosphate-buffered saline (pH 7.4). The mixture will then be centrifuged at 13,000 g for 10 min at 4 °C. RANKL, Osteoprotegerin (OPG), Total Oxidative Status (TOS), and Total Antioxidant Capacity (TAC) kits will be analyzed by ELISA. Results will be expressed as pg/μL.

Time frame
4th month

Other outcomes

Sponsors and contacts

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