Periodontal Health in Adults Treated With Fixed Orthodontic Appliances or Clear Aligners
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRavan Mammadov
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Individuals aged 18 years or older
Systemically healthy individuals
Periodontally healthy individuals or those diagnosed with gingivitis
Probing pocket depth of 3 mm or less, with no clinical attachment loss and no reduced periodontium
Disqualifiers
Pregnant or breastfeeding individuals
Individuals with systemic disease that could influence periodontal status
Current use of cigarettes or other tobacco products
Individuals with a history of initial periodontal therapy within the preceding six months
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Fixed Orthodontic Appliance
DeviceBracket-and-archwire system used for orthodontic tooth movement.
Clear Aligner Therapy
DeviceRemovable thermoplastic aligners used for orthodontic tooth movement.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: CA Group (Clear Aligner Therapy)1 intervention
Group B: FOA Group (Fixed Orthodontic Appliances)1 intervention
Trial outcomes
Primary outcomes
1
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).2
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).3
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).4
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).Secondary outcomes
1
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).2
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).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Ravan Mammadov
Lead sponsor
Altinbas University
Sponsor institution
Source ClinicalTrials.gov