Side Effects of Different Treatment Methods

NCT06709287 | Completed

• 1 other identifier: 17/2
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Root Resorption; Pain; Chewing Function

Keywords

root resorption; pain; chewing function; fixed orthodontic treatment; clear aligner therapy

Outcome Measures

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.

  0-1 months

Study Arms (2)

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

clear aligners OTHER

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

clear aligners

orthodontic metal bracket OTHER

Conventional metal bracket.

Also known as: conventional bracket

fixed orthodontic treatment

Eligibility Criteria

• Age: 12 Years - 29 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakif University

Fatih, Istanbul, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Root Resorption; Pain

Condition Hierarchy (Ancestors)

Tooth Resorption; Tooth Diseases; Stomatognathic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: November 29, 2024
• Study Start: April 11, 2020
• Primary Completion: August 4, 2022
• Study Completion: August 26, 2022
• Last Updated: December 5, 2024

Record last verified: 2024-12

Locations

TU (1)