Side Effects of Different Treatment Methods

Completed

• Conditions: Root Resorption; Pain; Chewing Function

• Registration Number: NCT06709287
• Lead Sponsor: Bezmialem Vakif University

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.

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 Timeline

• Study Start: 2020-04-11
• Primary Completion: 2022-08-04
• Study Completion: 2022-08-26
• Study First Submitted: 2024-10-15
• Study First Submitted QC: 2024-11-26
• Study First Posted: 2024-11-29
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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.

Read More

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.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcomes of the study were pain scores and chewing performance scores.	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.

Trial Locations

Locations (1)

Bezmialem Vakif University; 🇹🇷 Fatih, Istanbul, Turkey