Caries Inhibition With CO2-Laser During Orthodontic Treatment

June 9, 2021 updated by: Plovdiv Medical University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Bulgaria
      • Plovdiv, Bulgaria, 4000
        • Department of Paediatric Dentistry, Faculty of Dental Medicine, Medical University - Plovdiv, Bulgaria
        • Contact:
        • Contact:
      • Plovdiv, Bulgaria, 4000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fluoride and Laser
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
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.
Active Comparator: Fluoride
In the split-mouth design, this arm - the contralateral teeth (right maxillary incisors), will receive topical fluoride application.
Procedure: Topical fluoride application
Topical fluoride varnish application (Clinpro™ White Varnish 5% Sodium Fluoride, 3M ESPE, USA) of the vestibular surfaces of the left maxillary anterior teeth

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes into International Caries Detection and Assessment System (ICDAS) codes
Time Frame: 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in SoproLife ® scores
Time Frame: 1 year
The SOPROlife score is a visual assessment of the caries levels. The SoproLife ® daylight intraoral camera (SoproLife ® Daylight mode) is used to record an intraoral picture with Sopro-imaging software (Acteon, Sopro, La Ciotat, France). The SoproLife ® blue fluorescence mode scores range from 0 to 5. Code of '0' is given when the surface appears shiny green, the enamel appears sound, and there are no visible changes, code '1' - a tiny, thin red shimmer is observed, no red dots appeared, code '2' - darker red spots are visible, code '3' - dark red spots have extended, a slight beginning roughness of the red areas can be visible, and codes '4-6' represent larger carious lesions in dentin.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Plovdiv Medical University

Investigators

  • Study Director: Ani B Belcheva, PhD, Medical University Plovdiv, Bulgaria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2021

Primary Completion (Anticipated)

August 1, 2023

Study Completion (Anticipated)

August 1, 2023

Study Registration Dates

First Submitted

May 21, 2021

First Submitted That Met QC Criteria

May 21, 2021

First Posted (Actual)

May 26, 2021

Study Record Updates

Last Update Posted (Actual)

June 10, 2021

Last Update Submitted That Met QC Criteria

June 9, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MedicalUniversity_LaserCentre

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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