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A Study Comparing How Regular clear aligner and direct Printed Clear Aligners Used for Teeth Straightening May Release Chemicals into Saliva While Worn in the Mouth

Assessment and quantification of chemicals leached from PETG and direct printed aligners using FTIR spectroscopy: An in vivo study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/10/096118
Enrollment
22
Registered
2025-10-15
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: - Health Condition 2: 2- Placement

Interventions

Intervention1: PETG based aligner: Chemicals leaching from PETG based aligner Control Intervention1: Direct Printed aligner: chemicals leaching from Direct printed aligner

Sponsors

Dr Sajad Ahammad N
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients who require orthodontic therapy - Participants must be chosen based on the necessity for orthodontic treatment to correct malocclusion, Age Range 18-40 Years - Subjects in this age range should have a fully formed dentition and minimal age-related variability in salivary composition, Good Oral Health,Participants must be free of active periodontal disease, untreated dental caries, and other oral diseases that might interfere with chemical leaching studies.

Exclusion criteria

Exclusion criteria: Individuals having a history of allergy to plastics or methacrylate-based materials will be excluded to guarantee safety and accuracy in chemical evaluation,Patients with Composite restoration, Patients who take drugs that affect salivary pH or flow rate (e.g., anticholinergics, antidepressants) will be excluded to avoid confusing effects on chemical release.

Design outcomes

Primary

MeasureTime frame
what are the chemicals leaching from the alignerTimepoint: 14 days

Secondary

MeasureTime frame
to quantify the chemicalsTimepoint: 14 days

Countries

India

Contacts

Public ContactSajad ahammad

Shree Bankey Bihari Dental College

sunanda.9@hotmail.com9810007709

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026