An observational study in Malocclusion, Periodontal Diseases and Periodontal Health, sponsored by Ravan Mammadov. Active, not recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by Ravan Mammadov · Observational
This prospective observational study will compare the effects of fixed orthodontic appliances and clear aligners on periodontal health during the initial three months of orthodontic treatment. Thirty systemically healthy adults will be included in two groups of fifteen according to the orthodontic treatment modality received. Prior to appliance placement, all participants will undergo standardized non-surgical periodontal treatment and receive oral hygiene instructions. Periodontal parameters, including plaque accumulation, gingival inflammation, bleeding on probing, probing pocket depth, and clinical attachment level, will be assessed at baseline, following periodontal treatment, and at the third month of orthodontic therapy. Patient-reported outcomes related to oral health-related quality of life, gingival symptoms, and oral hygiene difficulty will also be evaluated. The study aims to determine whether periodontal and patient-reported outcomes differ between fixed orthodontic appliances and clear aligners during the early phase of orthodontic treatment.
323 studies on the registry are indexed under Malocclusion; 85 are open to participants now.
This study's planned enrollment of 30 is below the median of 63 across 74 observational studies indexed under Malocclusion.
Browse Malocclusion studies →This is the only study on the registry with Ravan Mammadov as lead sponsor.
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Systemically healthy adults aged 18 years and older who are periodontally healthy or have gingivitis and have an indication for orthodontic treatment without tooth extraction will be recruited from patients presenting to the Altınbaş University Dental Hospital.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants who will receive clear aligner therapy for correction of malocclusion. Prior to appliance placement, all participants will undergo standardized non-surgical periodontal treatment and receive oral hygiene instructions. Periodontal parameters and patient-reported outcomes will be assessed at baseline, after periodontal treatment, and at the third month of orthodontic therapy.
Device: Clear Aligner Therapy
Participants who will receive fixed orthodontic appliances (brackets and archwires) for correction of malocclusion. Prior to appliance placement, all participants will undergo standardized non-surgical periodontal treatment and receive oral hygiene instructions. Periodontal parameters and patient-reported outcomes will be assessed at baseline, after periodontal treatment, and at the third month of orthodontic therapy.
Device: Fixed Orthodontic Appliance
Bracket-and-archwire system used for orthodontic tooth movement.
Removable thermoplastic aligners used for orthodontic tooth movement.
Change in Full Mouth Plaque Score (FMPS) Between Fixed Orthodontic Appliance and Clear Aligner Groups
Full Mouth Plaque Score (FMPS) will be calculated as the percentage of tooth surfaces exhibiting visible plaque. The scale ranges from 0% to 100%, with higher scores indicating greater plaque accumulation and poorer plaque control.
Time frame: Baseline (T0), after non-surgical periodontal treatment / before orthodontic treatment initiation (T1), and 3 months after orthodontic treatment initiation (T2).
Change in Bleeding on Probing (BoP) Between Fixed Orthodontic Appliance and Clear Aligner Groups
Bleeding on probing (BoP) will be assessed at six sites per tooth using a periodontal probe. Bleeding occurring within 30 seconds after probing will be recorded as positive. The BoP score will be calculated as the percentage of bleeding-positive sites relative to the total number of sites examined, ranging from 0% to 100%, with higher scores indicating greater gingival inflammation.
Time frame: Baseline (T0), after non-surgical periodontal treatment / before orthodontic treatment initiation (T1), and 3 months after orthodontic treatment initiation (T2).
Change in Gingival Index (GI) Between Fixed Orthodontic Appliance and Clear Aligner Groups
Gingival Index (GI) will be assessed according to the Löe and Silness criteria at six sites per tooth. The scale ranges from 0 to 3, where 0 indicates normal gingiva and 3 indicates severe gingival inflammation with a tendency for spontaneous bleeding. Higher scores indicate worse gingival inflammation.
Time frame: Baseline (T0), after non-surgical periodontal treatment / before orthodontic treatment initiation (T1), and 3 months after orthodontic treatment initiation (T2).
Change in Probing Pocket Depth (PPD) Between Fixed Orthodontic Appliance and Clear Aligner Groups
Probing Pocket Depth (PPD) will be measured at six sites per tooth using a UNC-15 periodontal probe. PPD will be recorded in millimeters as the distance from the gingival margin to the base of the periodontal sulcus or pocket. Higher values indicate greater probing depth.
Time frame: Baseline (T0), after non-surgical periodontal treatment / before orthodontic treatment initiation (T1), and 3 months after orthodontic treatment initiation (T2).
Change in Clinical Attachment Level (CAL) Between Fixed Orthodontic Appliance and Clear Aligner Groups
Clinical Attachment Level (CAL) will be measured at six sites per tooth using a periodontal probe and recorded in millimeters as the distance from the cementoenamel junction to the base of the periodontal sulcus or pocket. Higher values indicate greater attachment loss.
Time frame: Baseline (T0), after non-surgical periodontal treatment / before orthodontic treatment initiation (T1), and 3 months after orthodontic treatment initiation (T2).
Change in Oral Health Impact Profile-14 (OHIP-14) Score Between Fixed Orthodontic Appliance and Clear Aligner Groups
Oral health-related quality of life will be assessed using the Oral Health Impact Profile-14 (OHIP-14). The questionnaire includes 14 items scored on a 5-point Likert scale from 0 (never) to 4 (very often), producing a total score ranging from 0 to 56. Higher scores indicate poorer oral health-related quality of life.
Time frame: Baseline (T0) and 3 months after orthodontic treatment initiation (T2).
Visual Analog Scale (VAS) Scores for Gingival Symptoms and Oral Hygiene Difficulty Between Fixed Orthodontic Appliance and Clear Aligner Groups
Patient-reported gingival symptoms and oral hygiene difficulty will be assessed using an 8-item Visual Analog Scale (VAS). Each item will be scored from 0 to 10. Higher scores will indicate greater symptom severity or greater oral hygiene difficulty for the symptom and difficulty items, whereas higher scores on the gingival health satisfaction item will indicate greater satisfaction.
Time frame: At 3 months after orthodontic treatment initiation (T2).
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Individual participant data will not be shared to protect patient confidentiality and privacy.
Started Sep 2026 (actual). Primary completion is estimated for Dec 2026, 3 months after the start.
Of 32 observational studies under Malocclusion, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 46. This study's planned 3 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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