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OpenTrials
Completed

NCT Number: NCT06709287

Side Effects of Different Treatment Methods

this study aimed to compare the effects of fixed orthodontic treatment and clear aligner therapy on root resorption, periodontal status, pain experience and chewing performance.

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Key information

Age range

12 year–29 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bezmialem Vakif University

Fatih, Istanbul, 34093, Turkey (Türkiye)

About this study

The aim of the study is to compare the potential side effects of fixed orthodontic treatment and clear aligner therapy. 27 individuals who were treated with clear aligners (20 Female, 7 Male; mean age: 22.57 ± 7.37) and 22 patients treated with braces (14 Female, 8 Male; mean age: 17.05 ± 4.51) formed the study group. The periodontal statuses of the patients(Probing depth, bleeding on probing, plaque index) were evaluated before treatment (T0), 3 months (T1) after, and at 6th month (T2) following the beginning of the treatment. The amount of root resorption in maxillary & mandibular incisors was evaluated on periapical radiographies taken with the paralleling technique. Pain experience and chewing function were also recorded during treatment.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • patients treated with fixed braces or clear aligners
  • patients with mild to moderate crowding
  • patients without root canal treatment or resorption in anterior teeth
  • patients with completed root development
  • patients with good periodontal health at the beginning of the treatment
  • patients with no congenitally missing or impacted tooth.

Exclusion criteria

  • history of orthodontic therapy
  • poor patient compliance
  • presence of any craniofacial syndrome or systemic disease
  • presence of cleft lip and palate
  • trauma history
  • mental retardation
  • use of oral antiseptic solutions during orthodontic treatment
  • need for scaling and root planning during treatment
  • clear aligner patients with delayed movement of the anterior teeth.

Treatment and study plan

clear aligners

Other

The investigators measured pain and chewing performance at 8 time points during the first 6 months.

orthodontic metal bracket

Other

Conventional metal bracket.

Other names: conventional bracket

Primary outcomes

  1. The primary outcomes of the study were pain scores and chewing performance scores.

    Time frame: 0-1 months

    The Visual Analog Scale has been used to evaluate pain scores and chewing performance. According to this scale, high scores represent good masticatory performance and high pain. Low scores represent poor masticatory performance and low pain.

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

Comparison of Orthodontics Adverse Effects: Braces Versus Clear Aligners

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 29, 2024
Registry last updated
Dec 5, 2024

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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