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

NCT07399483 | Active Not Recruiting

• 1 other identifier: MS.25.08.67
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Gingival crevicular fluid (GCF) Interleukin-1β (IL-1β) Prostaglandin E2 (PGE2) Cytokines Tooth mobility 3D digital superimposition; gingival cervical fluid , tooth mobility , Interleukin-1β (IL-1β) Prostaglandin E2; Gingival crevicular fluid (GCF) , Interleukin-1β (IL-1β) ,Prostaglandin E2 (PGE2), mobility test

Outcome Measures

Primary Outcomes (1)

• Interleukin-1β and Prostaglandin E2

  counting of Interleukin-1β and Prostaglandin E2 in gingival crevicular fluid

  4 week

Secondary Outcomes (3)

• amount of tooth movement

  4 weeks

• tooth mobility

  4 weeks

• pain evaluation

  2 weeks

Study Arms (2)

fixed orthodontic appliance

EXPERIMENTAL

counting of Interleukin-1β and Prostaglandin E2 in gingival crevicular fluid, evaluation of the amount of tooth movement using intraoral scan and superimposition, tooth mobility using periotest devise and pain evaluation during orthodontic treatment

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

clear aligner appliance

EXPERIMENTAL

counting of Interleukin-1β and Prostaglandin E2 in gingival crevicular fluid, evaluation of the amount of tooth movement using intraoral scan and superimposition, tooth mobility using periotest devise and pain evaluation during orthodontic treatment

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

Interventions

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

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

clear aligner appliance; fixed orthodontic appliance

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult patients aged 18-25 years.
• Skeletal class I mild dental crowding per arch (≤ 4 mm).
• Good oral hygiene and no active periodontal disease.
• Normal vertical SN-GOGN angle 32+- 3.

You may not qualify if:

• Patients with severe crowding or spacing (\> 4 mm).
• Presence of active dental caries or periodontal disease.
• History of orthodontic treatment within the past two years.
• Systemic conditions affecting tooth movement (e.g., diabetes, bone disorders).
• Bimaxillary protrusion, sever proclination

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura university

Al Mansurah, El Mansoura, Dakahlia Governorate, 35516, Egypt

Location

MeSH Terms

Conditions

Tooth Mobility

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Mohamad Alamin Ahmed Elmansor

  Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: February 10, 2026
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)