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Cytotoxicity of metal corrosion caused by fluoride products in orthodontic patients

Cytotoxicity, genotoxicity, and cellular metal accumulation caused by professionally-applied fluoride products in patients with fixed orthodontic appliances: A randomized clinical trial.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20210513003
Enrollment
44
Registered
2021-05-13
Start date
2018-09-03
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Cytotoxic and genotoxic effect of buccal mucosal cells in patients wearing fixed-orthodontic appliances. Cytotoxicity Genotoxicity Fluoride Orthodontic appliances

Interventions

The subjects were bonded with fixed orthodontic appliances on both arches and did not receive professional fluoride application. ,The subjects were bonded with fixed orthodontic appliances on both arc
No Intervention No treatment,Experimental Drug,Experimental Drug,Experimental Drug
Control group,Acidulated phosphate fluoride gel ,Neutral fluoride gel ,Fluoride varnish

Sponsors

Faculty of Dentistry, Chulalongkorn University, Thailand (Lecturer Fund)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 35 Years

Inclusion criteria

Inclusion criteria: 1.permanent dentition with all second molars erupted in the oral cavity 2.clinically healthy oral mucosa 3.no previous orthodontic treatment 4.no occupational exposure to metals 5.no amalgam fillings or metal restorations 6.no lingual appliances or extraoral auxiliary appliances

Exclusion criteria

Exclusion criteria: 1.smoking 2.pre-existing systemic diseases or medication associated with oral mucosa changes

Design outcomes

Primary

MeasureTime frame
Level of metal ions in buccal mucosal cells Before treatment and 3 months after appliance placement Inductively coupled plasma-mass spectrometry (ICP-MS)

Secondary

MeasureTime frame
Cell viability Before treatment and 3 months after appliance placement Trypan blue exclusion test ,Frequency of cellular death Before treatment and 3 months after appliance placement The cells were underwent Papanicolaou staining and were scored using a light microscope.,Number of micronucleated cell Before treatment and 3 months after appliance placement The cells were underwent Papanicolaou staining and were scored using a light microscope.

Countries

Thailand

Contacts

Public ContactPintuon Chantarawaratit

Department of Orthodontics, Faculty of Dentistry, Chulalongkorn University

pintuon@gmail.com022188930

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026