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CompletedNCT06709287Updated Dec 5, 2024

Side Effects of Different Treatment Methods

An observational study in Root Resorption, Pain and Chewing Function, sponsored by Bezmialem Vakif University. Completed at 1 site in Turkey. Open to participants aged 12 Years to 29 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-05.

Sponsored by Bezmialem Vakif University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
49
Ages
12 Years to 29 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Root Resorption
  • Pain
  • Chewing Function

Keywords

  • root resorption
  • pain
  • chewing function
  • fixed orthodontic treatment
  • clear aligner therapy
03

In context

Root Resorption

43 studies on the registry are indexed under Root Resorption; 9 are open to participants now.

Browse Root Resorption studies →

Lead sponsor

Bezmialem Vakif University is the lead sponsor of 354 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 29 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
49 participants (actual)
Target follow-up
6 Months
Patient registry
Yes

Groups and cohorts

  • 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

  • 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

Interventions

  • Otherclear aligners

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

  • Otherorthodontic metal bracket

    Conventional metal bracket.

    Also known as: conventional bracket

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 0-1 months

07

Study locations

1 site
  • Bezmialem Vakif University
    Fatih, Istanbul 34093, Turkey
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06709287
Responsible party
Sponsor
First posted
Nov 29, 2024
Start date
Apr 11, 2020
Primary completion
Aug 4, 2022
Completion
Aug 26, 2022
Last update
Dec 5, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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