Caries Inhibition With CO2-Laser During Orthodontic Treatment

Plovdiv Medical University

Status: Unknown

Conditions: Caries; Initial

Treatments: Procedure: Topical fluoride application and Laser irradiation; Procedure: Topical fluoride application

Study type: Interventional

Funder types: Other

Identifiers

NCT04903275

MedicalUniversity_LaserCentre

Details and patient eligibility

About

The aim of the study is to assess the viability and efficacy of carbon dioxide laser in combination with a fluoride varnish in the prevention, severity, and extent of white spot lesions during orthodontic treatment with fixed appliances.

Full description

White spot lesions associated with orthodontic treatment are a common problem. The carbon dioxide laser is reported to be the most effective one in the prevention of dental caries. The study is designed as a randomized, split-mouth controlled, clinical trial. The participants will be children aged 12-18 years at high caries risk, requiring fixed orthodontic treatment. The vestibular surfaces of the maxillary anterior teeth of the eligible patients will be exposed to carbon dioxide laser irradiation in combination with fluoride therapy and fluoride therapy alone followed by bonding of orthodontic brackets. The patients will be recalled 6 and 12 months post-irradiation. Outcome measures will be visual examination with the International Caries Detection and Assessment System (ICDAS) criteria and SoproLife ® Daylight and Blue fluorescence.

Enrollment: 41 estimated patients

Sex: All

Ages: 12 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants in the study are children ages 12 and older, in good general health
• Children, requiring fixed orthodontic treatment (brackets)
• Children at high caries risk according to 'Oral disease risk assessment tool' accepted and used in the Department of Paediatric Dentistry, Faculty of Dental medicine, Medical University - Plovdiv, Bulgaria
• Children with untreated non-carious vestibular surfaces of the six maxillary anterior teeth of the permanent dentition (central and lateral incisors, canines) with ICDAS code 0
• Verbal assent from the child willing to comply with all study procedures and protocol
• Obtained written informed consent by the patient's parent/guardian for participation in the study

Exclusion criteria

• Children with systemic diseases that may affect oral health or oral microflora (such as diabetes, etc.)
• Children with medication intake that could affect the salivary flow or oral microflora (such as antibiotics, etc.)
• Children with mental or cognitive problems
• Patients with maxillary anterior permanent teeth affected by disturbances in the development of dental structures (hypoplasia, hypomineralization, fluorosis)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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41 participants in 2 patient groups

Fluoride and Laser

Experimental group

Description:

In the split-mouth design, the left maxillary anterior teeth receive topical fluoride application and carbon dioxide (CO2) laser irradiation.

Treatment:

Procedure: Topical fluoride application and Laser irradiation

Fluoride

Active Comparator group

Description:

In the split-mouth design, this arm - the contralateral teeth (right maxillary incisors), will receive topical fluoride application.

Treatment:

Procedure: Topical fluoride application