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NCT Number: NCT07802249

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

This prospective study compares the effects of fixed orthodontic appliances (braces) and clear aligners on periodontal health during the initial three months of orthodontic treatment. Thirty systemically healthy adults were allocated into two groups of fifteen. Prior to appliance placement, all participants underwent standardized non-surgical periodontal treatment and received oral hygiene instructions. Periodontal parameters, including plaque accumulation, gingival inflammation, and probing measurements, were assessed at baseline, following periodontal treatment, and at the third month of orthodontic therapy. Patient-reported outcomes regarding oral hygiene difficulty and quality of life were also evaluated. The study aims to determine which appliance type is associated with more favorable periodontal outcomes and easier oral hygiene maintenance during the early phase of orthodontic treatment.

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Key information

Conditions

Malocclusion, Periodontal Diseases Malocclusion Mouth Diseases Periodontal Diseases Stomatognathic Diseases Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Altınbaş University Dental Hospital

Istanbul, Bakirköy, 34147, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Indication for orthodontic treatment
  • Orthodontic treatment planned without tooth extraction
  • Less than 5 mm of dental crowding in both the maxillary and mandibular arches, as determined by Hayes-Nance arch-length discrepancy analysis

Exclusion criteria

  • 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
  • Individuals who had previously undergone orthodontic treatment

Treatment and study plan

Fixed orthodontic appliance

Device

Bracket-and-archwire system used for orthodontic tooth movement.

Clear aligner therapy

Device

Removable thermoplastic aligners used for orthodontic tooth movement.

Primary outcomes

  1. Change in Full Mouth Plaque Score (FMPS) Between Fixed Orthodontic Appliance and Clear Aligner Groups

    Time frame: Baseline (T0), after non-surgical periodontal treatment / pre-orthodontic initiation (T1), and at the third month of orthodontic therapy (T2)

    Full-mouth plaque accumulation was assessed to evaluate the percentage of tooth surfaces exhibiting visible plaque.

  2. Change in Bleeding on Probing (BoP) Between Fixed Orthodontic Appliance and Clear Aligner Groups

    Time frame: Baseline (T0), after non-surgical periodontal treatment / pre-orthodontic initiation (T1), and at the third month of orthodontic therapy (T2)

    Bleeding on probing was assessed at six sites per tooth using a periodontal probe. Bleeding occurring within 30 seconds following probing was recorded as positive; the BoP score was calculated as the percentage of bleeding-positive sites relative to the total number of sites examined.

  3. Change in Gingival Index (GI) Between Fixed Orthodontic Appliance and Clear Aligner Groups

    Time frame: Baseline (T0), after non-surgical periodontal treatment / pre-orthodontic initiation (T1), and at the third month of orthodontic therapy (T2)

    Gingival inflammatory status was assessed using the Gingival Index (GI) based on the criteria of Löe and Silness (1963), evaluated at six sites per tooth on a 0-3 scale based on visual signs of inflammation and bleeding upon gentle probing.

  4. Change in Probing Pocket Depth (PPD) Between Fixed Orthodontic Appliance and Clear Aligner Groups

    Time frame: Baseline (T0), after non-surgical periodontal treatment / pre-orthodontic initiation (T1), and at the third month of orthodontic therapy (T2)

    Probing pocket depth was measured at six sites per tooth using a UNC-15 periodontal probe, recorded as the distance from the gingival margin to the base of the periodontal pocket.

  5. Change in Clinical Attachment Level (CAL) Between Fixed Orthodontic Appliance and Clear Aligner Groups

    Time frame: Baseline (T0), after non-surgical periodontal treatment / pre-orthodontic initiation (T1), and at the third month of orthodontic therapy (T2)

    Clinical attachment level was measured at six sites per tooth using a periodontal probe, recorded as the distance between the gingival margin and the base of the periodontal pocket.

Secondary outcomes

  1. Change in Oral Health Impact Profile-14 (OHIP-14) Score Between Fixed Orthodontic Appliance and Clear Aligner Groups

    Time frame: Baseline (T0) and at the third month of orthodontic therapy (T2)

    Oral health-related quality of life was assessed using the Turkish version of the 14-item OHIP-14 questionnaire, with responses scored on a 5-point Likert scale ranging from 0 (never) to 4 (very often).

  2. Change in Visual Analog Scale (VAS) Scores for Oral Hygiene Difficulty Between Fixed Orthodontic Appliance and Clear Aligner Groups

    Time frame: At the third month of orthodontic therapy (T2)

    Patient-reported gingival symptoms and oral hygiene difficulty, including toothbrushing, interdental cleaning, gingival bleeding, swelling, and satisfaction with gingival health, were assessed using a 0-10 Visual Analog Scale.

Sponsors and collaborators

Lead sponsor

Ravan Mammadov

Other

Registry information

Official study title

Comparative Effects of Fixed Orthodontic Appliances and Clear Aligners on Periodontal Health

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 3, 2026
Registry last updated
Sep 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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