Side Effects of Different Treatment Methods

Comparison of Orthodontics Adverse Effects: Braces Versus Clear Aligners

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.

Study Overview

• Status: Completed
• Conditions: Pain; Root Resorption; Chewing Function
• Intervention / Treatment: Other: orthodontic metal bracket; Other: clear aligners

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 49

Contacts and Locations

Study Locations

• Turkey
  • Istanbul
    • Fatih, Istanbul, Turkey, 34093
      • Bezmialem Vakif University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

22 patients (14 females, 8 males; mean age: 17.05 ± 4.51 years) who underwent fixed orthodontic therapy were included in the fixed treatment group and 27 patients (20 females, 7 males; mean age: 22.57 ± 7.37 years) who underwent clear aligner therapy were included in the clear aligner group.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
fixed orthodontic treatment; The patients in this group were treated with conventional braces.The patients were treated with 0.018-inch slot metal Roth brackets. Pretreatment (T0) digital lateral cephalometric radiographs were taken from the patients to compare pretreatment characteristics between the groups.The digital periapical radiographs taken with the paralleling technique were obtained.The digital periapical radiographs taken with the paralleling technique were obtained from the maxillary and mandibular incisors at the beginning of the treatment (T0) and after 6 months (T2).Probing depth, plaque index, and bleeding on probing were record at T0, after 3 months of treatment(T1), and at 6months(T2) to evaluate the periodontal status of the patients.A 5-question survey was used to evaluate pain levels, and a 9-question survey was used to evaluate chewing performance.	Other: orthodontic metal bracket; Conventional metal bracket.; Other Names: conventional bracket
clear aligners; The patients in this group were treated with clear aligners. Anterior teeth movement started from the first pair of aligners. Microfill and brace paste primers were used for bonding the attachments. Pretreatment (T0) digital lateral cephalometric radiographs were taken from the patients to compare pretreatment characteristics between the groups.The digital periapical radiographs taken with the paralleling technique were obtained.The digital periapical radiographs taken with the paralleling technique were obtained from the maxillary and mandibular incisors at the beginning of the treatment (T0) and after 6 months (T2).Probing depth, plaque index, and bleeding on probing were record at T0, after 3 months of treatment(T1), and at 6months(T2) to evaluate the periodontal status of the patients.A 5-question survey was used to evaluate pain levels, and a 9-question survey was used to evaluate chewing performance.	Other: clear aligners; The investigators measured pain and chewing performance at 8 time points during the first 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary outcomes of the study were pain scores and chewing performance scores.	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.	0-1 months

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2020
• Primary Completion (Actual): August 4, 2022
• Study Completion (Actual): August 26, 2022

Study Registration Dates

• First Submitted: October 15, 2024
• First Submitted That Met QC Criteria: November 26, 2024
• First Posted (Actual): November 29, 2024

Study Record Updates

• Last Update Posted (Estimated): December 5, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: pain; root resorption; fixed orthodontic treatment; clear aligner therapy; chewing function
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Resorption; Root Resorption
• Other Study ID Numbers: 17/2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No