Clinical trial NCT04903275: Caries Inhibition With CO2-Laser During Orthodontic Treatment
Official title: Caries Inhibition With CO2-Laser During Orthodontic Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Caries; Initial
Keywords: carbon dioxide laser
fluoride
orthodontic treatment
caries inhibition
Lead sponsor: Plovdiv Medical University
Sponsor class: OTHER
First posted: 2021-05-26
Enrollment: 41
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: randomized, split-mouth controlled, clinical trial
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Changes into International Caries Detection and Assessment System (ICDAS) codes
timeFrame: 1 year
Secondary outcomes:
measure: Changes in SoproLife ® scores
timeFrame: 1 year
Other outcomes:
Locations:
city: Plovdiv
country: Bulgaria
facility: Department of Paediatric Dentistry, Faculty of Dental Medicine, Medical University - Plovdiv, Bulgaria
city: Plovdiv
country: Bulgaria
facility: Medical University - Plovdiv, Bulgaria
Study officials:
affiliation: Medical University Plovdiv, Bulgaria
name: Ani B Belcheva, PhD
role: STUDY_DIRECTOR
References:
citation: Belcheva AB, Shindova MP. Caries inhibition with CO2-laser during orthodontic treatment: a study protocol for a randomized split-mouth controlled clinical trial. Trials. 2022 Mar 12;23(1):208. doi: 10.1186/s13063-022-06117-y.