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Oral cell changes due to use of fluoride while undergoing orthodontic treatment

Effect of fluoride on the cytotoxicity of buccal mucosa cells in the presence of nickel-titanium archwires during comprehensive orthodontic treatment: A randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/04/042323
Enrollment
75
Registered
2022-04-29
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

Health Condition 1: K088- Other specified disorders of teethand supporting structures

Interventions

Intervention1: Nickel titanium archwire and stainless steel brackets: Nickel titanium archwires will be ligated to stainless steel brackets. Fluoridated mouthwash and toothpaste will be prescribed. Su

Sponsors

Mayur Bhola
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy subjects with minimum crowding or spacing in maxillary and mandibular arches. 2. Presence of full complement of teeth except for 3rd molars. 3. Good oral hygiene (Oral Hygiene Index-Simplified Score < 1.2).

Exclusion criteria

Exclusion criteria: 1. History of orthodontic treatment. 2. Subject who fails to maintain good oral hygiene during study period. 3. Subjects with pregnancy. 4. Subjects having any known syndrome or metabolic disorder affecting salivary glands. 5. Subjects with any oral premalignant disorders. 6. Subjects with metallic restoration or prosthesis. 7. Subjects with occupational exposure to metals. 8. Subjects on long-term medications like NSAIDs or steroids. 9. Subjects with known allergy to nickel. 10. Lack of manual dexterity. 11. Any medications for a systemic illness. 12. History of recent bacterial or viral infection. 13. Subjects who smoke or consume alcohol. 14. Subjects not willing to participate in the study.

Design outcomes

Secondary

MeasureTime frame
Cell micronucleus scoring of buccal mucosa cellsTimepoint: Cell micronucleus scoring at 0 and 3 months.

Primary

MeasureTime frame
Cell viability percentageTimepoint: Cell viability percentage measured at 0 and 3 months.

Countries

India

Contacts

Public ContactMayur Bhola

AIIMS, Bhubaneswar

dent_ashok@aiimsbhubaneswar.edu.in9438884077

Outcome results

None listed

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