Er:YAG Laser Therapy in Combination With Behaviour Management Technique in Reducing Anxiety Among Paediatric Patients

Efficiency of Er:YAG Laser Therapy in Combination With Behaviour Management Technique in Reducing Anxiety Among Paediatric Dental Patients

The aim of the study is to assess the efficacy of a modified version of the behaviour management technique Latent inhibition in combination with Er:YAG laser for achieving reduction of dental anxiety in paediatric dental patients. The main objectives are to compare dental anxiety felt during the laser and conventional dental treatment. The outcomes will be dental anxiety assessment by a self-reported anxiety during treatment in both group as well as measurement of heart rate dynamics during the procedures.

Study Overview

• Status: Not yet recruiting
• Conditions: Dental Caries; Dental Anxiety; Behavior
• Intervention / Treatment: Procedure: Laser conditioning and Sealant application; Device: Er:YAG laser therapy; Procedure: Sealant application; Procedure: Conventional therapy

Detailed Description

When providing dental care to child patients with a high level of dental anxiety, the range of approaches are divided into two sections - use of behavior management techniques and application of alternative methods for caries removal. In attempt to reduce dental anxiety, they can be mixed and matched in accordance with the dentists' choice. Owing to the promoted advantages Er:YAG laser turns into an ideal alternative technique for hard dental tissue therapy in anxious pediatric patients.This is a protocol for a randomized controlled clinical trial. The participants will be children aged aged 6-12 years, requiring conservative treatment of occlusal carious lesions on a second primary molar. Patients will be randomly assigned to experimental or control group via computer-generated sequence. In both groups Latent inhibition will be used as an anxiety-management technique. In the experimental group caries treatment will be performed with Erbium:YAG laser, whereas in the control group with the conventional rotary instruments. Outcome measures will be dental anxiety felt before and after the treatment and the dynamics of heart rate, registered during the treatment session.

• Study Type: Interventional
• Enrollment (Anticipated): 82
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria Shindova, PhD; Phone Number: 00359898390935; Email: mariya.shindova@gmail.com

Study Locations

• Bulgaria
  • Plovdiv, Bulgaria, 4000
    • Department of Paediatric Dentistry, Faculty of Dental Medicine, Medical University - Plovdiv, Bulgaria
    • Contact: Maria P Shindova, PhD; Phone Number: 00359898390935; Email: mariya.shindova@gmail.com
    • Contact: Ani B Belcheva, PhD; Phone Number: 00359889528932; Email: abeltcheva@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Participants in the study are children aged 6-12 years, compliant with the cognitive development of the child and the requirement for complete root development;
2. Children, requiring conservative treatment of occlusal carious lesions on a second primary molar, without spontaneous unprovoked pain, percussion or palpation pain or other symptoms, indicating pulp involvement or periodontal pathology. Lesions are classified as distinct cavity with visible dentin without prior restoration or sealants by the International Caries Detection and Assessment System (ICDAS) with code 05. Included are caries lesions only on vital teeth.
3. Children with one or more permanent molars giving indications for pit and fissure sealing;
4. Patients without previous experience with laser treatment of carious lesions;
5. Children who are not considered medically compromised or medically complex patients;
6. Verbal assent from the child willing to comply with all study procedures and protocol;
7. Obtained written informed consent by the patient's parent/guardian for participation in the study

Exclusion Criteria:

1. Patients who were undergoing therapy with neurological, sedative, analgesic, and/or anti-inflammatory drugs 7 days prior to treatment that might affect heart rate;
2. Children, who were first-time dental patients;
3. Children with systemic diseases or physiological development delays;
4. Children with mental or cognitive problems;
5. Present infectious diseases such as influenza, scarlet fever, etc.
6. Excluded are molars which are affected by disturbances in the development of dental structures (hypoplasia, hypomineralization, fluorosis)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Er:YAG laser therapy; Er:YAG laser will be used for enamel conditioning of the occlusal surfaces of the permanent molars before sealant application as well as the standardized caries treatment.	Procedure: Laser conditioning and Sealant application; Sealant application protocol includes: a low-speed rubber cup and pumice paste (CleanPolish, Kerr) will be used for 30 seconds for cleaning and polishing of the occlusal surface of the chosen permanent molar; tooth surface will be washed for debris and organic residue removal and dried with air spray; isolation; laser conditioning of the occlusal enamel surface. The parameter settings used will be: tip-to-tissue distance 1.5mm from the tooth surface; tip diameter 600 µm; laser energy 70 mJ; pulse frequency 10 Hz; water spray level 8; average power 0.7 W; energy density 67 J/cm2; tooth surface will be etched with 35% phosphoric acid gel (Etching gel, DMP Ltd) for 30 seconds and rinsed for the same time; reisolation; tooth surface will be dried with air spray for 15s; fissure sealant application (Pit&Fissure Sealant, DMP Ltd); light cured for 20 seconds.; Device: Er:YAG laser therapy; Er:YAG laser (LiteTouch, Light Instruments LTD), emission wavelength 2940 nm will be used for caries removal - parameters: enamel removal - energy 100-200mJ; density 9.84-13.03 J/cm2, pulse frequency 20Hz; tip diameter 800 μm; water spray level 8; tip-to-tissue distance 0.5÷1 mm form the tooth surface; dentin removal - energy 100mJ; density 9.84 J/cm2, pulse frequency 20Hz; tip diameter 800 μm; water spray level 8; tip-to-tissue distance 0.5÷1 mm form the tooth surface. Restoration with compomer.
Active Comparator: Conventional therapy; Conventional rotary instruments will be used for caries treatment.	Procedure: Sealant application; Sealant application protocol includes: a low-speed rubber cup and pumice paste (CleanPolish, Kerr) will be used for 30 seconds for cleaning and polishing of the occlusal surface of the chosen permanent molar; tooth surface will be washed for debris and organic residue removal and dried with air spray; isolation; tooth surface will be etched with 35% phosphoric acid gel (Etching gel, DMP Ltd) for 30 seconds and rinsed for the same time; reisolation; tooth surface will be dried with air spray for 15s; fissure sealant application (Pit&Fissure Sealant, DMP Ltd); light cured for 20 seconds.; Procedure: Conventional therapy; Conventional rotary instruments will be used for caries removal - high-speed and low-speed dental handpieces. Restoration with compomer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
self-report dental anxiety on a modified version of the self-report Faces Scale by LeBaron	The scale comprises a row of five faces ranging from 'relaxed' to 'very worried' in combination with a visual analog scale of 0 - 10. Each child was asked to point to the face or choose the number which most closely depicted its state of anxiety.	Immediately after the dental treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	Dynamics of heart rate, registered during the treatment session measured throughout the whole treatment session with a mobile pulse oximeter, placed on the index finger of the left hand	start: in the waiting room, at least 5 minutes before the dental treatment. End: at least 5 minutes after the dental treatment.

Collaborators and Investigators

• Sponsor: Plovdiv Medical University
• Investigators: Principal Investigator: Maria Shindova, PhD, Medical University Plovdiv, Bulgaria

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: June 3, 2021
• First Submitted That Met QC Criteria: June 9, 2021
• First Posted (Actual): June 14, 2021

Study Record Updates

• Last Update Posted (Actual): June 14, 2021
• Last Update Submitted That Met QC Criteria: June 9, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: anxiety; Er:YAG laser; management technique; paediatric dentistry
• Additional Relevant MeSH Terms: Mental Disorders; Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Anxiety Disorders; Dental Caries
• Other Study ID Numbers: MedicalUniversity_BMT

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