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

Primary Purpose

Dental Caries, Dental Anxiety, Behavior

Status

Unknown status

Phase

Not Applicable

Locations

Bulgaria

Study Type

Interventional

Intervention

Laser conditioning and Sealant application

Sealant application

Er:YAG laser therapy

Conventional therapy

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring Er:YAG laser, anxiety, management technique, paediatric dentistry

Eligibility Criteria

6 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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;
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.
Children with one or more permanent molars giving indications for pit and fissure sealing;
Patients without previous experience with laser treatment of carious lesions;
Children who are not considered medically compromised or medically complex patients;
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:

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Er:YAG laser therapy

Conventional therapy

Arm Description

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.

Conventional rotary instruments will be used for caries treatment.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT04924452

First Posted

June 3, 2021

Last Updated

June 9, 2021

Sponsor

Plovdiv Medical University

1. Study Identification

Unique Protocol Identification Number

NCT04924452

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Unknown status

Study Start Date

September 1, 2021 (Anticipated)

Primary Completion Date

September 2022 (Anticipated)

Study Completion Date

September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Plovdiv Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental Caries, Dental Anxiety, Behavior

Keywords

Er:YAG laser, anxiety, management technique, paediatric dentistry

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

randomized parallel-group controlled clinical study

Masking

Participant

Masking Description

The randomisation will be independent and the patients and parents/guardians will remain blinded to group status.

Allocation

Randomized

Enrollment

82 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Er:YAG laser therapy

Arm Type

Experimental

Arm Description

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.

Arm Title

Conventional therapy

Arm Type

Active Comparator

Arm Description

Conventional rotary instruments will be used for caries treatment.

Intervention Type

Procedure

Intervention Name(s)

Laser conditioning and Sealant application

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Sealant application

Intervention Description

Intervention Type

Device

Intervention Name(s)

Er:YAG laser therapy

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Conventional therapy

Intervention Description

Conventional rotary instruments will be used for caries removal - high-speed and low-speed dental handpieces. Restoration with compomer.

Primary Outcome Measure Information:

Title

self-report dental anxiety on a modified version of the self-report Faces Scale by LeBaron

Description

Time Frame

Immediately after the dental treatment

Secondary Outcome Measure Information:

Title

Heart rate

Description

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

Time Frame

start: in the waiting room, at least 5 minutes before the dental treatment. End: at least 5 minutes after the dental treatment.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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; 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. Children with one or more permanent molars giving indications for pit and fissure sealing; Patients without previous experience with laser treatment of carious lesions; Children who are not considered medically compromised or medically complex patients; 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: Patients who were undergoing therapy with neurological, sedative, analgesic, and/or anti-inflammatory drugs 7 days prior to treatment that might affect heart rate; Children, who were first-time dental patients; Children with systemic diseases or physiological development delays; Children with mental or cognitive problems; Present infectious diseases such as influenza, scarlet fever, etc. Excluded are molars which are affected by disturbances in the development of dental structures (hypoplasia, hypomineralization, fluorosis)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Maria Shindova, PhD

Phone

00359898390935

mariya.shindova@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maria Shindova, PhD

Organizational Affiliation

Medical University Plovdiv, Bulgaria

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Plovdiv

ZIP/Postal Code

4000

Country

Bulgaria

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maria P Shindova, PhD

Phone

00359898390935

mariya.shindova@gmail.com

First Name & Middle Initial & Last Name & Degree

Ani B Belcheva, PhD

Phone

00359889528932

abeltcheva@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD

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

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