MalocclusionNCT07127744
Relationship Between Malocclusion Severity and Periodontitis Risk
An observational study of Malocclusion, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Malocclusion
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2025to 19 Jan 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients coming to the Periodontology Clinic of Recep Tayyip Erdoğan University Faculty of Dentistry for routine periodontal treatment
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Department of Periodontology of the Faculty of Dentistry of Recep Tayyip Erdogan University
Rize, Rize Province, 53200
RTEU Faculty of Dentistry, Department of Periodontology, +90 464 222 00 00, dis@erdogan.edu.tr
About this study
Official title: Determination of the Relationship Between Orthodontic Malocclusion Severity and Periodontitis Risk Using RANKL, OPG and Oxidative Stress Markers
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:
Read more
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.
Read the 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.
- Conditions
- Malocclusion
- Keywords
- malocclusion, periodontitis, RANKL, Osteoprotegerin, oxidative stress
- Medical subject headings
- Malocclusion, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
- No visible plaque, but a slight film of plaque is detected when a probe is run along the gingival margin.
- Visible plaque along the gingival margin, forming a continuous band.
- Abundant plaque covering the gingival area and extending toward the middle of the tooth surface, including the interproximal spaces.
Measured: 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
- Single-point, slight bleeding
- Thin line of blood
- Obvious and rapid bleeding across the entire papilla, slight spreading
- Severe, profuse bleeding that overflows the papilla, usually with evident inflammation
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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.
Measured: 4th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start15 Sep 2025 (estimated)
- Primary completion15 Dec 2025 (estimated)
- Study completion19 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalocclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek KARADOĞAN, Recep Tayyip Erdogan University Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07127744
- Sponsor's protocol ID
- periortho05/2025
- Status last verified
- Aug 2025
- First submitted
- 10 Aug 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Relationship Between Orthodontic Malocclusion Severity and Periodontitis Risk Using RANKL, OPG and Oxidative Stress Markers
- ClinicalTrials.gov ID
- NCT07127744
- Acronym / sponsor ID
- periortho05/2025
- Conditions
- Malocclusion
- Keywords
- malocclusion, periodontitis, RANKL, Osteoprotegerin, oxidative stress
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 19 Jan 2026 (estimated)
- First posted
- 17 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients coming to the Periodontology Clinic of Recep Tayyip Erdoğan University Faculty of Dentistry for routine periodontal treatment
Key inclusion criteria (6 listed)
- 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),
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gingival crevicular fluid collection
Time frame: Day 1
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.
Clinical Periodontal Parameters (Plaque Index)
Time frame: Day 1
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.
Periodontal Clinical Parametres (Papillary Bleeding Index)
Time frame: Day 1
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
Periodontal Clinical Parametres (Bleeding on Probing Index)
Time frame: Day 1
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)
Periodontal Clinical Parametres (Probing Pocket Depth)
Time frame: Day 1
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)
Periodontal Clinical Parametres (Clinical Attachment Loss)
Time frame: Day 1
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
1 secondary outcome
Determination of RANKL, OPG, TAS and TAC by ELISA
Time frame: 4th month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malocclusion, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oguz KOSE, Professor Dr. (+90 541 348 64 65, oguz.kose@erdogan.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingival crevicular fluid collection (time frame: Day 1). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.