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

NCT07802249 | Recruiting

• 1 other identifier: FOACA-2026-01
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Periodontal Diseases; Malocclusion; Periodontal Health

Keywords

Periodontal Health, Clear Aligners, Fixed Orthodontic Appliances, Dental Biofilm, Oral Health Impact Profile-14, Visual Analog Scale

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  Baseline (T0), after non-surgical periodontal treatment / before orthodontic treatment initiation (T1), and 3 months after orthodontic treatment initiation (T2).

Secondary Outcomes (2)

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

  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

  At 3 months after orthodontic treatment initiation (T2).

Study Arms (2)

CA Group (Clear Aligner Therapy)

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

FOA Group (Fixed Orthodontic Appliances)

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

Interventions

Fixed Orthodontic Appliance DEVICE

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

FOA Group (Fixed Orthodontic Appliances)

Clear Aligner Therapy DEVICE

Removable thermoplastic aligners used for orthodontic tooth movement.

CA Group (Clear Aligner Therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ravan Mammadov: lead

Study Sites (1)

Altınbaş University Dental Hospital

Istanbul, Bakirköy, 34147, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Malocclusion; Periodontal Diseases

Interventions

Orthodontic Appliances, Fixed

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Mouth Diseases

Intervention Hierarchy (Ancestors)

Orthodontic Appliances; Orthodontics; Dentistry

Study Officials

• Ravan Mammadov

  Altınbaş University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ravan Mammadov, DDS

CONTACT

+994507310770; revan.mamedov@gmail.com

Gulhuseyn Abdullayev, PhD, DDS

CONTACT

+994506770005; g.abdullayev20@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD Candidate, Department of Periodontology, Altınbaş University

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 3, 2026
• Study Start: September 11, 2026
• Primary Completion (Estimated): December 25, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: September 15, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)