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

Completed

• Conditions: Other specified disorders of teethand supporting structures,

• Registration Number: CTRI/2022/04/042323
• Lead Sponsor: Mayur Bhola

Brief Summary

The comprehensive orthodontic treatment utilizes brackets and archwires for the correction of malocclusion. Archwires transmit forces to the tooth via brackets causing movement of the tooth in the desired direction. Enamel white spot lesions are a common iatrogenic outcome of orthodontic treatment. Fluoride-containing mouthwash and toothpaste are routinely recommended to prevent white spot lesions. Fluoride may enhance the corrosion of bracket and archwire alloys. Corrosion products released from these archwires may have cytotoxic effects on the buccal mucosa cells.

Thus, the current study is planned to evaluate the effect of fluoride on the cytotoxicity of buccal mucosa cells in the presence of nickel-titanium archwires during comprehensive orthodontic treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-07
• Study Completion: 2023-04-12
• Last Update Posted: 2023-12-21

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

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

Exclusion Criteria

• History of orthodontic treatment.
• Subject who fails to maintain good oral hygiene during study period.
• Subjects with pregnancy.
• Subjects having any known syndrome or metabolic disorder affecting salivary glands.
• Subjects with any oral premalignant disorders.
• Subjects with metallic restoration or prosthesis.
• Subjects on long-term medications like NSAIDs or steroids.
• Subjects with known allergy to nickel.
• Lack of manual dexterity.
• Any medications for a systemic illness.
• History of recent bacterial or viral infection.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cell viability percentage	Cell viability percentage measured at 0 and 3 months.

Secondary Outcome Measures

Name	Time	Method
Cell micronucleus scoring of buccal mucosa cells	Cell micronucleus scoring at 0 and 3 months.

Trial Locations

Locations (1)

Department of dentistry, AIIMS bhubaneswar; 🇮🇳 Khordha, ORISSA, India

Department of dentistry, AIIMS bhubaneswar

🇮🇳Khordha, ORISSA, India

Mayur bhola

Principal investigator

9990921867

mb.bhola@gmail.com