Cytotoxicity of metal corrosion caused by fluoride products in orthodontic patients

Phase 2

Completed

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

• Registration Number: TCTR20210513003
• Lead Sponsor: Faculty of Dentistry, Chulalongkorn University, Thailand (Lecturer Fund)

Brief Summary

Applying acidulated phosphate fluoride gel on fixed orthodontic appliances increased the cell metal ion content and decreased cell viability; however, genotoxic effects were absent.

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-04-24
• Study Start: 2021-05-13
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 44

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
evel of metal ions in buccal mucosal cells Before treatment and 3 months after appliance placement Inductively coupled plasma-mass spectrometry (ICP-MS)

Secondary Outcome Measures

Name	Time	Method
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.