Dental CariesNCT04924452
Er:YAG Laser Therapy in Combination With Behaviour Management Technique in Reducing Anxiety Among Paediatric Patients
A study testing Laser conditioning and Sealant application, Sealant application and Er:YAG laser therapy in people with Dental Caries and Dental Anxiety, run by Plovdiv Medical University at 1 site in Bulgaria.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Dental Anxiety, Behavior
- What is being tested?
- Laser conditioning and Sealant application, Sealant application and Er:YAG laser therapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteBulgaria
- Study dates
- 1 Sep 2021to Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Bulgaria1 site
Department of Paediatric Dentistry, Faculty of Dental Medicine, Medical University - Plovdiv, Bulgaria
Plovdiv, 4000
Maria P Shindova, PhD, 00359898390935, mariya.shindova@gmail.com
Ani B Belcheva, PhD, 00359889528932, abeltcheva@yahoo.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Dental Caries, Dental Anxiety, Behavior
- Being tested
- Laser conditioning and Sealant application, Sealant application, Er:YAG laser therapy, Conventional therapy
- Keywords
- Er:YAG laser, anxiety, management technique, paediatric dentistry
- Medical subject headings
- Dental Caries, Behavior, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser conditioning and Sealant applicationProcedure or surgery
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.
Sealant applicationProcedure or surgery
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.
Er:YAG laser therapyDevice
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.
Conventional therapyProcedure or surgery
Conventional rotary instruments will be used for caries removal - high-speed and low-speed dental handpieces. Restoration with compomer.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Laser conditioning and Sealant application; Device: Er:YAG laser therapy |
| Conventional therapy | Active comparator | Conventional rotary instruments will be used for caries treatment. Receives: Procedure: Sealant application; Procedure: Conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after the dental treatment
Secondary outcomes (1)
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
Measured: start: in the waiting room, at least 5 minutes before the dental treatment. End: at least 5 minutes after the dental treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start1 Sep 2021 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized parallel-group controlled clinical study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Plovdiv Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Shindova, PhD, Principal investigator, Medical University Plovdiv, Bulgaria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04924452
- Sponsor's protocol ID
- MedicalUniversity_BMT
- Status last verified
- Jun 2021
- First submitted
- 3 Jun 2021
- Last updated
- 14 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36691137
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Er:YAG Laser Therapy in Combination With Behaviour Management Technique in Reducing Anxiety Among Paediatric Dental Patients
- ClinicalTrials.gov ID
- NCT04924452
- Acronym / sponsor ID
- MedicalUniversity_BMT
- Conditions
- Dental Caries, Dental Anxiety, Behavior
- Keywords
- Er:YAG laser, anxiety, management technique, paediatric dentistry
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Plovdiv Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 14 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized parallel-group controlled clinical study
| Arm | Type | Receives |
|---|---|---|
| Er:YAG laser therapy | Experimental | Procedure: Laser conditioning and Sealant application, Device: Er:YAG laser therapyEr: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 therapy | Active comparator | Procedure: Sealant application, Procedure: Conventional therapyConventional rotary instruments will be used for caries treatment. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser conditioning and Sealant applicationSealant 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. | Procedure or surgery | Er:YAG laser therapy |
| Sealant applicationSealant 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 or surgery | Conventional therapy |
| Er:YAG laser therapyEr: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. | Device | Er:YAG laser therapy |
| Conventional therapyConventional rotary instruments will be used for caries removal - high-speed and low-speed dental handpieces. Restoration with compomer. | Procedure or surgery | Conventional therapy |
Primary outcome
self-report dental anxiety on a modified version of the self-report Faces Scale by LeBaron
Time frame: Immediately after the dental treatment
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.
1 secondary outcome
Heart rate
Time frame: start: in the waiting room, at least 5 minutes before the dental treatment. End: at least 5 minutes after the dental treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
- Derived from this study: PubMed 36691137Belcheva 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Shindova, PhD principal investigator
Medical University Plovdiv, Bulgaria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser conditioning and Sealant application, Sealant application and Er:YAG laser therapy in people with Dental Caries and Dental Anxiety, run by Plovdiv Medical University at 1 site in Bulgaria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Shindova, PhD (00359898390935, mariya.shindova@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
self-report dental anxiety on a modified version of the self-report Faces Scale by LeBaron (time frame: Immediately after the dental treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04924452, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2021.