Caries Inhibition With CO2-Laser During Orthodontic Treatment

NCT04903275 | Unknown DMC

• 1 other identifier: MedicalUniversity_LaserCentre
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

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.

Conditions

Caries; Initial

Keywords

carbon dioxide laser; fluoride; orthodontic treatment; caries inhibition

Outcome Measures

Primary Outcomes (1)

• Changes into International Caries Detection and Assessment System (ICDAS) codes

  The International Caries and Detection System (ICDAS) is a visual scoring system developed for use in clinical assessment and clinical research of caries development and progression. It uses a numbered scoring system with a range from 0 to 6, to grade enamel demineralization and cavitation. Code of '0' represents unaffected/sound enamel, no caries change, '1' - first visual change, represents initial demineralization that is visible only after air drying, '2' represents a distinct visual change in the enamel that is visible when the surface is wet, '3' represents localized enamel loss or breakdown, no visible dentin or underlying shadow, and '4-6' represent larger carious lesions in dentin.

  1 year

Secondary Outcomes (1)

• Changes in SoproLife ® scores

  1 year

Study Arms (2)

Fluoride and Laser

EXPERIMENTAL

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

Procedure: Topical fluoride application and Laser irradiation

Fluoride

ACTIVE COMPARATOR

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

Procedure: Topical fluoride application

Interventions

Topical fluoride application and Laser irradiation PROCEDURE

Topical fluoride varnish application (Clinpro™ White Varnish 5% Sodium Fluoride, 3M ESPE, USA) of the vestibular surfaces of the left maxillary anterior teeth followed by laser irradiation with CO2-laser (Ultra Dream Pulse, DS\_40U, Daeshin Enterprise, Seoul, South Korea), emission wavelength 10,600 nm, time on-100 μs, time off-40 ms; average power-0.73 W; peak power-292.73 W; speed of movement-2 mm/s; energy density with movements-5 J/cm2; tip-to-tissue distance-20 mm; tip diameter 700 μm; irradiation time-30 s.

Fluoride and Laser

Topical fluoride application PROCEDURE

Topical fluoride varnish application (Clinpro™ White Varnish 5% Sodium Fluoride, 3M ESPE, USA) of the vestibular surfaces of the left maxillary anterior teeth

Fluoride

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Plovdiv Medical University: lead

Study Sites (2)

Department of Paediatric Dentistry, Faculty of Dental Medicine, Medical University - Plovdiv, Bulgaria

Plovdiv, 4000, Bulgaria

Location

Medical University - Plovdiv, Bulgaria

Plovdiv, 4000, Bulgaria

Location

Related Publications (1)

• 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.

  PMID: 35279220 DERIVED

MeSH Terms

Interventions

Fluoride Treatment

Intervention Hierarchy (Ancestors)

Fluoridation; Preventive Dentistry; Dentistry

Study Officials

• Ani B Belcheva, PhD

  Medical University Plovdiv, Bulgaria

  STUDY DIRECTOR

Central Study Contacts

Maria Shindova, PhD

CONTACT

00359898390935; mariya.shindova@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized, split-mouth controlled, clinical trial

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: May 26, 2021
• Study Start: September 1, 2021
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: June 10, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

BU (2)