Periodontal Health in Adults Treated With Fixed Orthodontic Appliances or Clear Aligners

Condition(s) studied

Investigational drug(s) / intervention(s)

Fixed Orthodontic Appliance: Bracket-and-archwire system used for orthodontic tooth movement.

Clear Aligner Therapy: Removable thermoplastic aligners used for orthodontic tooth movement.

Study summary

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

Primary outcome measure(s)

• Change in Full Mouth Plaque Score (FMPS) Between Fixed Orthodontic Appliance and Clear Aligner Groups — Baseline (T0), after non-surgical periodontal treatment / before orthodontic treatment initiation (T1), and 3 months after orthodontic treatment initiation (T2).
  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.
• Change in Bleeding on Probing (BoP) Between Fixed Orthodontic Appliance and Clear Aligner Groups — Baseline (T0), after non-surgical periodontal treatment / before orthodontic treatment initiation (T1), and 3 months after orthodontic treatment initiation (T2).
  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.
• Change in Gingival Index (GI) Between Fixed Orthodontic Appliance and Clear Aligner Groups — Baseline (T0), after non-surgical periodontal treatment / before orthodontic treatment initiation (T1), and 3 months after orthodontic treatment initiation (T2).
  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.
• Change in Probing Pocket Depth (PPD) Between Fixed Orthodontic Appliance and Clear Aligner Groups — Baseline (T0), after non-surgical periodontal treatment / before orthodontic treatment initiation (T1), and 3 months after orthodontic treatment initiation (T2).
  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.
• Change in Clinical Attachment Level (CAL) Between Fixed Orthodontic Appliance and Clear Aligner Groups — Baseline (T0), after non-surgical periodontal treatment / before orthodontic treatment initiation (T1), and 3 months after orthodontic treatment initiation (T2).
  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.

Trial sites (1)

Other trials for the same condition