Split-Mouth Comparison of Invisalign Attachments

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-30

Study Completion Date

2028-06-30

Brief Summary

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This study evaluates how accurately the attachments used in Invisalign treatment (Align Technology Inc., San Jose, CA, USA) match their planned shapes and sizes in the ClinCheck software (ClinCheck®, Align Technology Inc., San Jose, CA, USA). Attachments are small tooth-colored bumps that help clear aligners grip the teeth and move them effectively.

The investigators are comparing two types of attachments: optimized and conventional, to determine which is bonded to the tooth more accurately and maintains its shape better over time. Participants beginning Invisalign treatment will have attachments placed as part of their normal care. Digital scans will be taken immediately after placement and during follow-up visits to assess attachment accuracy and wear.

The goal is to identify which attachment design provides greater precision and durability to improve the predictability and efficiency of Invisalign treatment planning.

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Detailed Description

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Conditions

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Wear, Restoration Volume Assessment Clear Aligner Appliance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This is a prospective, randomized split-mouth (crossover) study evaluating two types of Invisalign attachments: optimized and conventional. Each participant receives both attachment types on contralateral teeth, allowing within-subject comparison of placement accuracy and wear under identical clinical conditions.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Optimized

Optimized attachments are small, tooth-colored composite bumps placed on teeth during Invisalign treatment to help aligners deliver controlled forces for tooth movement. These attachments are digitally designed in the ClinCheck software to optimize force direction and retention. In this arm, optimized attachments will be bonded according to the manufacturer's standard template and curing protocols. Their bonded geometry and wear over time will be compared to those of conventional attachments placed on the contralateral teeth.

Group Type ACTIVE_COMPARATOR

Composite Aligner Attachment

Intervention Type DEVICE

Composite aligner attachments are small, tooth-colored resin bumps bonded to specific teeth during Invisalign treatment to enhance aligner retention and force application. These attachments are digitally planned in ClinCheck software and fabricated using manufacturer-provided templates. In this study, two designs: optimized and conventional, will be compared for their accuracy and durability using 3D digital scans at multiple time points.

Conventional

Conventional attachments are tooth-colored composite bumps placed on teeth during Invisalign treatment to improve aligner retention and control tooth movement. These attachments are designed with standard rectangular or ellipsoid shapes, following established clinical templates. In this arm, conventional attachments will be bonded using manufacturer-recommended materials and curing protocols. Their placement accuracy and wear characteristics will be compared to those of optimized attachments placed on the contralateral teeth within the same participant.

Group Type ACTIVE_COMPARATOR

Composite Aligner Attachment

Intervention Type DEVICE

Composite aligner attachments are small, tooth-colored resin bumps bonded to specific teeth during Invisalign treatment to enhance aligner retention and force application. These attachments are digitally planned in ClinCheck software and fabricated using manufacturer-provided templates. In this study, two designs: optimized and conventional, will be compared for their accuracy and durability using 3D digital scans at multiple time points.

Interventions

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Composite Aligner Attachment

Composite aligner attachments are small, tooth-colored resin bumps bonded to specific teeth during Invisalign treatment to enhance aligner retention and force application. These attachments are digitally planned in ClinCheck software and fabricated using manufacturer-provided templates. In this study, two designs: optimized and conventional, will be compared for their accuracy and durability using 3D digital scans at multiple time points.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adults aged18 years or older.
* Patients initiating Invisalign treatment with planned composite attachments.
* Ability to provide written informed consent and agree to additional research intra-oral scans.
* Good oral hygiene and absence of active periodontal disease at enrollment.

Exclusion Criteria

* Extensive dental restorations (composites, crowns, veneers) on study teeth that could interfere with attachment bonding.
* Enamel defects or severe wear on study tooth surfaces affecting bonding accuracy.
* Contraindications to digital intraoral scanning (e.g., severe gag reflex, metallic prostheses preventing accurate imaging).
* Severe tooth malposition that would compromise accurate attachment placement.
* Poor oral hygiene or active periodontal disease at enrollment and/or if the patient develops poor oral hygiene or active periodontal disease during treatment.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No