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

NCT04924452 | Unknown

• 1 other identifier: MedicalUniversity_BMT
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries; Dental Anxiety; Behavior

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Heart rate

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

Study Arms (2)

Er:YAG laser therapy

EXPERIMENTAL

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; Device: Er:YAG laser therapy

Conventional therapy

ACTIVE COMPARATOR

Conventional rotary instruments will be used for caries treatment.

Procedure: Sealant application; Procedure: Conventional therapy

Interventions

Laser conditioning and Sealant application PROCEDURE

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.

Er:YAG laser therapy

Sealant application PROCEDURE

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.

Conventional therapy

Er:YAG laser therapy DEVICE

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.

Er:YAG laser therapy

Conventional therapy PROCEDURE

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

Conventional therapy

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Plovdiv Medical University: lead

Study Sites (1)

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

Plovdiv, 4000, Bulgaria

Location

Related Publications (1)

• Belcheva A, Shindova M. Efficiency of ER:YAG laser therapy in combination with behaviour management technique in reducing anxiety among paediatric dental patients - a study protocol for a randomised clinical trial. BMJ Open. 2022 Sep 5;12(9):e054523. doi: 10.1136/bmjopen-2021-054523.

  PMID: 36691137 DERIVED

MeSH Terms

Conditions

Dental Caries; Behavior; Anxiety Disorders

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Mental Disorders

Study Officials

• Maria Shindova, PhD

  Medical University Plovdiv, Bulgaria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Shindova, PhD

CONTACT

00359898390935; mariya.shindova@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The randomisation will be independent and the patients and parents/guardians will remain blinded to group status.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized parallel-group controlled clinical study

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: June 14, 2021
• Study Start: September 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: June 14, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)