Effect of Finishing Clear Aligner Marginal Termination Design (Supragingival vs Juxtagingival) on Aligner Color Stability After 14 Days of Wear: A Split-Mouth Study

Summary

* The goal of this clinical study is to learn whether the gumline edge design of a finishing orthodontic clear aligner affects how much the aligner's color changes after 14 days of wear.
* The main question is: does a supragingival edge design - a straight edge covering about 2 mm of gum tissue - lead to a different amount of color change in the aligner compared with a juxtagingival edge design that follows the gumline exactly, after 14 days of wear?
* Each participant wears finishing clear aligners with both edge designs at the same time - one design on the upper jaw and the other on the lower jaw - and serves as their own comparison (split-mouth). This within-person approach removes differences between individuals in oral hygiene, diet, and saliva.
* The aligner's color over six selected teeth (three upper, three lower) is measured with a dental spectrophotometer (VITA Easyshade V) at placement (day 0) and after 14 days. Each measurement is repeated three times under standardized optical conditions. The amount of color change is expressed as a color-difference value (ΔE).
* The study hypothesis is that marginal termination design (supragingival versus juxtagingival) is associated with a difference in the 14-day colorimetric change (ΔE00) of the finishing aligner.
* The study is carried out during the finishing (refinement) stage of orthodontic treatment, when only small residual tooth movements remain, so that color changes can be attributed to wear and edge design rather than to tooth movement.

Conditions

• Malocclusion
• Esthetics, Dental

Interventions

DEVICE

Tri-layer thermoplastic finishing clear aligner

Finishing clear aligner fabricated from CA Pro tri-layer thermoplastic (SCHEU-DENTAL GmbH, Iserlohn, Germany; CE-marked), fabricated by SC APARAT DENTAR SRL, Sibiu, Romania. Each participant receives aligners with both trimming-line designs simultaneously - supragingival on one arch and juxtagingival festooned on the contralateral arch. Material and thickness are identical for both designs; only trimming-line geometry differs. (Cross-referenced to both arms.)

Sponsors & Collaborators

• Aorys Clinic, Sibiu, Romania

  collaborator UNKNOWN

• SC APARAT DENTAR SRL, Sibiu, Romania

  collaborator UNKNOWN

• George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures

  lead OTHER

Principal Investigators

• EMILIA (PRODEA) RUSU, DDS, Specialist Orthodontist · George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu Mures, 38 Gheorghe Marinescu Street, 540139 Targu Mures, Romania

• LUMINITA LAZAR, PhD, Professor · George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu Mures, 38 Gheorghe Marinescu Street, 540139 Targu Mures, Romania

Study Design

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

15 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-15

Primary Completion

2026-07-23

Completion

2026-07-23

Countries

• Romania

Study Locations