Split-Mouth Comparison of Invisalign Attachments
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Composite Aligner Attachment.
- Who it may be relevant to
- Registry conditions: Wear, Restoration, Volume Assessment, Clear Aligner Appliance. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Accuracy of Invisalign Attachments: A Split-Mouth Comparative Study of Optimized and Conventional Designs
Overview
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.
Interventions
- Device 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.
Primary outcome measures
- Attachment Volume Accuracy [Time frame: 1 month]
- Attachment Active Surface Area Accuracy [Time frame: 1 month]
- Positional Accuracy [Time frame: 1 month]
Secondary outcome measures (4)
- Volume Reduction Over Time [Time frame: 6 months]
- Volume Loss (Percentage) [Time frame: 6 months]
- Active Surface Area Change Over Time [Time frame: 6 months]
- Active Surface Area Change (Percentage) [Time frame: 6 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Maryland School of Dentistry — Baltimore
Publications
- Muthuswamy Pandian S, Subramanian AK, Vaiid N. Comparison of efficacy and accuracy of tooth movements in optimized and conventional attachments of clear aligners - A systematic review and meta-analysis. J Oral Biol Craniofac Res. 2025 Sep-Oct;15(5):1123-1133. doi: 10.1016/j.jobcr.2025.07.019. Epub 2025 Jul 29. PMID 40778386
- Li Q, Yang K. Surface wear of attachments in patients during clear aligner therapy: a prospective clinical study. Prog Orthod. 2024 Feb 19;25(1):7. doi: 10.1186/s40510-023-00506-y. PMID 38369617
- Fausto da Veiga Jardim A, Curado de Freitas J, Estrela C. Surface wear and adhesive failure of resin attachments used in clear aligner orthodontic treatment. J Orofac Orthop. 2024 May;85(Suppl 1):52-62. doi: 10.1007/s00056-023-00471-5. Epub 2023 Jun 14. PMID 37314488
- Bellocchio AM, Portelli M, Ciraolo L, Ciancio E, Militi A, Peditto M, Barbera S, Nucera R. Evaluation of the Clinical Variables Affecting Attachment Reproduction Accuracy during Clear Aligner Therapy. Materials (Basel). 2023 Oct 23;16(20):6811. doi: 10.3390/ma16206811. PMID 37895792
Identifiers
NCT: NCT07215598 · HP-00115664