Side Effects of Different Treatment Methods

NCT ID: NCT06709287

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

49 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-11

Study Completion Date

2022-08-26

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Root Resorption Pain Chewing Function

Keywords

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root resorption pain chewing function fixed orthodontic treatment clear aligner therapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

orthodontic metal bracket

Intervention Type OTHER

Conventional 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.

clear aligners

Intervention Type OTHER

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

Interventions

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clear aligners

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

Intervention Type OTHER

orthodontic metal bracket

Conventional metal bracket.

Intervention Type OTHER

Other Intervention Names

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conventional bracket

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

29 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bezmialem Vakif University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Bezmialem Vakif University

Fatih, Istanbul, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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17/2

Identifier Type: -

Identifier Source: org_study_id