Evaluation of the Biomechanical Response of Orthodontic Tooth Movement to Clear Aligner vs Fixed Orthodontic Appliance

NCT07399483 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-02-10

No results posted yet for this study

Summary

Abstract

Background: Orthodontic tooth movement (OTM) is mediated by biologic responses of the periodontal ligament (PDL) and alveolar bone to applied mechanical forces, involving release of inflammatory mediators such as interleukin-1β (IL-1β) and prostaglandin E2 (PGE2) that promote osteoclast activation and bone remodeling. Intraoral biomarkers in gingival crevicular fluid (GCF) reflect these tissue changes and can be used to monitor inflammatory and metabolic responses during treatment. Digital technologies, including intraoral scanning and 3D superimposition, allow precise quantification of tooth movement over time.

Objective: This prospective, randomized comparative clinical study aims to compare the biological and mechanical responses of orthodontic tooth movement in patients treated with clear aligners versus conventional fixed appliances.

Methods: Twenty adult patients (aged 18-25 years) with mild dental crowding will be randomly assigned to either a fixed appliance group (n=10) or a clear aligner group (n=10). Baseline and follow-up GCF samples will be collected to quantify IL-1β and PGE2 using enzyme-linked immunosorbent assay (ELISA). Tooth mobility will be assessed using Periotest analysis, and 3D digital models obtained from intraoral scans will be superimposed to measure the amount of tooth movement over time. Secondary outcomes include clinical measures of mobility and patient-reported pain.

Expected Outcomes: It is anticipated that both treatment modalities will induce measurable increases in inflammatory biomarkers and tooth movement; however, differences in the magnitude and temporal patterns of IL-1β, PGE2, tooth mobility, and 3D-quantified displacement are expected due to the continuous forces of fixed appliances versus intermittent forces of aligners. Previous studies have shown that GCF cytokine levels rise with orthodontic force application in both aligner and fixed appliance treatments, with some variations between groups.

Conclusion: This study will provide new clinical evidence comparing biological mediator profiles and mechanical outcomes between clear aligners and fixed orthodontic appliances, improving understanding of tissue responses and informing clinical decision-making in contemporary orthodontic practice

Conditions

  • Orthodontic Tooth Movement
  • Tooth Movement

Interventions

DIAGNOSTIC_TEST

diagnostic Test: Collection of GCF: from the gingival sulcus using paper point ,Tooth Mobility via Periotest ,3D Digital Model Superimposition using Intraoral Scanning

Diagnostic Tests Used in this Study 1. Gingival Crevicular Fluid (GCF) Biomarker Analysis • Collection of GCF: GCF is collected from the gingival sulcus using absorbent paper points to obtain 2. Tooth Mobility Measurement • Periotest Analysis: A mechanical diagnostic tool (Periotest device) that measures the damping characteristics of the periodontium by recording the reaction to a controlled tapping force is used 3. 3D Digital Model Superimposition using intraoral scan device

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • Mohamad Alamin Ahmed Elmansor · Mansoura University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2026-08-01
Completion
2026-11-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07399483 on ClinicalTrials.gov