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Effectiveness of Er:YAG Pulse Therapy for Achieving Pre-emptive Dental Analgesia in Children

Primary Purpose

Caries, Dental

Status
Completed
Phase
Not Applicable
Locations
Bulgaria
Study Type
Interventional
Intervention
Laser analgesic procedure
Placebo analgesic procedure
Sponsored by
Plovdiv Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Caries, Dental focused on measuring laser analgesia, pediatric dentistry

Eligibility Criteria

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

Exclusion criteria:

  • Children who are considered medically compromised or medically complex patients. The absence of disease is confirmed by anamnestic interview with a parent or a care-giver of the child and excludes general acute or chronic disease, cognitive impairment, psychogenic nonepileptic events, radiotherapy in the maxillofacial region due to malignant process.
  • Patients who are undergoing therapy with neurological, sedative, analgesic and/or anti-inflammatory drugs 7 days prior to treatment.
  • Children, who are first time ever dental patients.

Inclusion criteria:

  • Patients, identified as positive or definitely positive through Frankl behavioral rating scale.
  • Patients who are not undergoing treatment or have been treated 6 months prior to inclusion with remineralizing agents.
  • Patients, requiring conservative treatment of occlusal, caries on foramen caecum, and/or proximal caries on two first permanent upper jaw molars without prior restorations or dental sealants. Lesions are to be classified as moderate caries by the International caries detection and assessment system (ICDAS) with code 03 or code 04, which do not present spontaneous unprovoked pain, percussion or palpation pain or other symptoms, indicating of pulpal pathology. Included are carious lesions only on vital teeth, involving up to half of the dentine thickness, with no periodontal pathology. Laser fluorescence diagnosis of adjacent lesions with DIAGNODENT is limited to 20 - 35 scores included.
  • Included are first molars which are not affected by hypoplasia or hypomineralization.

Obtained informed consent from parents or gave-givers to participate in the study, in which laser treatment and study procedures are explained in appropriate manner.

Sites / Locations

  • Department of Pediatric Dentistry, Faculty of Dental Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Laser analgesia

Placebo analgesia

Arm Description

Procedure: Laser analgesic procedure Performing protocol for pre-emptive laser analgesia with Er:YAG laser (Litetouch, Syneron) switched on.

Procedure: Placebo analgesic procedure Performing imitation of laser analgesic protocol with Er:YAG laser (Litetouch, Syneron) switched off - no pulse energy applied.

Outcomes

Primary Outcome Measures

Pain felt during treatment according to a visual analogue scale
Reported by the patient at the end of the dental treatment session on a VAS (visual analogue scale), which contains a combination of Numeric Rating Scale (0-10, where 0 means no pain, 10 - worst possible pain) and Wong-Baker Faces Pain Scale, which includes pictures of facial expressions with correlating numbers of 0-10 (0 being 'no hurt' and 10 being 'hurts worst'). The combination allows children to pick a facial expression, that corresponds with their pain and see a number that matches it.

Secondary Outcome Measures

Changes in pulpal sensibility to electrical stimuli by electrical pulp tester
Evaluated via electrical pulp tester (EPT) 5 minutes before and on the 5th and 20th minute after laser/placebo analgesic procedure. EPT result is a number.
Changes in pulpal sensibility to cold-stimuli by a visual analogue scale
Cold-test is applied 4 minutes before and on the 6th and 21st minute after laser/placebo analgesia. Pain is reported by the patient on a VAS (visual analogue scale), which contains a combination of Numeric Rating Scale (0-10, where 0 means no pain, 10 - worst possible pain) and Wong-Baker Faces Pain Scale, which includes pictures of facial expressions with correlating numbers of 0-10 (0 being 'no hurt' and 10 being 'hurts worst').
Patient experience during analgesic or placebo procedure
evaluated by a patient questionnaire
Pain related behavior evaluated by the Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale
Evaluated by the outcomes assessor. The FLACC scale has five criteria - Faces, Legs, Activity, Cry, Consolability, which are each assigned a score of 0, 1 or 2. Total score of scale is summed in range 0 to 10, where: 0=relaxed and comfortable; 1-3=mild discomfort; 4-6=moderate pain; 7-10=severe pain.
Dynamics of the heart rate of the patient
registered throughout the experiment via pulse oximeter
Need for local anesthesia infiltration during the treatment
Registered with 1=no; 2=yes. Patients who request that the procedure is terminated to administer an anesthetic injection, are asked to rate their level of pain, according to aforementioned visual analogue scale, immediately following termination. The visual analogue scale contains a combination of Numeric Rating Scale (0-10, where 0 means no pain, 10 - worst possible pain) and Wong-Baker Faces Pain Scale, which includes pictures of facial expressions with correlating numbers of 0-10 (0 being 'no hurt' and 10 being 'hurts worst').

Full Information

First Posted
January 8, 2018
Last Updated
June 3, 2021
Sponsor
Plovdiv Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03412721
Brief Title
Effectiveness of Er:YAG Pulse Therapy for Achieving Pre-emptive Dental Analgesia in Children
Official Title
A Split-mouth Clinical Study on the Effectiveness of Er:YAG Pulse Therapy for Achieving Pre-emptive Dental Analgesia in Children
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
October 6, 2018 (Actual)
Primary Completion Date
May 1, 2019 (Actual)
Study Completion Date
September 8, 2019 (Actual)

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
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The aim of this study is to determine the effectiveness of Er:YAG pulse therapy for achieving pulpal analgesia in pediatric patients and to quantify the duration and extent of any effects assessed. Design: a randomized split-mouth study with two-way repeated measures design.
Detailed Description
The intention of the technique of "pre-emptive laser analgesia" is to reduce sensation in that small percentage of patients who may experience unpleasant sensations during caries removal. Laser analgesia is a non-invasive, non-thermogenic bio-modulation of the dental pulp reactivity aiming for reduction of impulse formation of the pulpal nociceptors. It is based on the idea that parallel with the ablative high-energy level laser action, simultaneous low level laser therapy (LLLT) may occur. We hypothesize that when operating at pulse energies below the Er:YAG laser ablation threshold of tooth structure, the laser energy leads to loss of impulse conduction of type A-delta nerve fibers in the dental pulp, leading to an analgesic effect.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caries, Dental
Keywords
laser analgesia, pediatric dentistry

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Allocation: Randomized Intervention Model: Split-mouth assignment with two-way repeated measures design Masking: Double (Participant, Outcomes Assessor)
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laser analgesia
Arm Type
Experimental
Arm Description
Procedure: Laser analgesic procedure Performing protocol for pre-emptive laser analgesia with Er:YAG laser (Litetouch, Syneron) switched on.
Arm Title
Placebo analgesia
Arm Type
Placebo Comparator
Arm Description
Procedure: Placebo analgesic procedure Performing imitation of laser analgesic protocol with Er:YAG laser (Litetouch, Syneron) switched off - no pulse energy applied.
Intervention Type
Procedure
Intervention Name(s)
Laser analgesic procedure
Intervention Description
Water mist spray set to "maximum", non-contact handpiece with sapphire tip. Tip-to-tissue distance 10 mm from the tooth neck, achieved by using a spacer. Energy is delivered to the enamel above the gingival margin adjacent to the cemento-enamel junction (perpendicularly towards the dental pulp) on each of the four line angles of the tooth for 30s, moving the laser handpiece in a sweeping action. Pulse energy - 0.2 W/ 10 Hz/ 20 mJ. Follows increase of energy and repetition of protocol - 0.6 W/ 15 Hz/ 40 mJ. Total duration of LA-induction - 240s.
Intervention Type
Procedure
Intervention Name(s)
Placebo analgesic procedure
Intervention Description
Performing imitation of laser analgesic procedure. No pulse energy applied, non-contact handpiece with sapphire tip. Moving the laser handpiece in a sweeping action towards the cemento-enamel junction (pointing perpendicularly towards the dental pulp) on each of the four line angles of the tooth. Total duration of placebo analgesia induction - 240s.
Primary Outcome Measure Information:
Title
Pain felt during treatment according to a visual analogue scale
Description
Reported by the patient at the end of the dental treatment session on a VAS (visual analogue scale), which contains a combination of Numeric Rating Scale (0-10, where 0 means no pain, 10 - worst possible pain) and Wong-Baker Faces Pain Scale, which includes pictures of facial expressions with correlating numbers of 0-10 (0 being 'no hurt' and 10 being 'hurts worst'). The combination allows children to pick a facial expression, that corresponds with their pain and see a number that matches it.
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Changes in pulpal sensibility to electrical stimuli by electrical pulp tester
Description
Evaluated via electrical pulp tester (EPT) 5 minutes before and on the 5th and 20th minute after laser/placebo analgesic procedure. EPT result is a number.
Time Frame
25 minutes
Title
Changes in pulpal sensibility to cold-stimuli by a visual analogue scale
Description
Cold-test is applied 4 minutes before and on the 6th and 21st minute after laser/placebo analgesia. Pain is reported by the patient on a VAS (visual analogue scale), which contains a combination of Numeric Rating Scale (0-10, where 0 means no pain, 10 - worst possible pain) and Wong-Baker Faces Pain Scale, which includes pictures of facial expressions with correlating numbers of 0-10 (0 being 'no hurt' and 10 being 'hurts worst').
Time Frame
25 minutes
Title
Patient experience during analgesic or placebo procedure
Description
evaluated by a patient questionnaire
Time Frame
5 minutes
Title
Pain related behavior evaluated by the Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale
Description
Evaluated by the outcomes assessor. The FLACC scale has five criteria - Faces, Legs, Activity, Cry, Consolability, which are each assigned a score of 0, 1 or 2. Total score of scale is summed in range 0 to 10, where: 0=relaxed and comfortable; 1-3=mild discomfort; 4-6=moderate pain; 7-10=severe pain.
Time Frame
1 hour
Title
Dynamics of the heart rate of the patient
Description
registered throughout the experiment via pulse oximeter
Time Frame
1 hour
Title
Need for local anesthesia infiltration during the treatment
Description
Registered with 1=no; 2=yes. Patients who request that the procedure is terminated to administer an anesthetic injection, are asked to rate their level of pain, according to aforementioned visual analogue scale, immediately following termination. The visual analogue scale contains a combination of Numeric Rating Scale (0-10, where 0 means no pain, 10 - worst possible pain) and Wong-Baker Faces Pain Scale, which includes pictures of facial expressions with correlating numbers of 0-10 (0 being 'no hurt' and 10 being 'hurts worst').
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Exclusion criteria: Children who are considered medically compromised or medically complex patients. The absence of disease is confirmed by anamnestic interview with a parent or a care-giver of the child and excludes general acute or chronic disease, cognitive impairment, psychogenic nonepileptic events, radiotherapy in the maxillofacial region due to malignant process. Patients who are undergoing therapy with neurological, sedative, analgesic and/or anti-inflammatory drugs 7 days prior to treatment. Children, who are first time ever dental patients. Inclusion criteria: Patients, identified as positive or definitely positive through Frankl behavioral rating scale. Patients who are not undergoing treatment or have been treated 6 months prior to inclusion with remineralizing agents. Patients, requiring conservative treatment of occlusal, caries on foramen caecum, and/or proximal caries on two first permanent upper jaw molars without prior restorations or dental sealants. Lesions are to be classified as moderate caries by the International caries detection and assessment system (ICDAS) with code 03 or code 04, which do not present spontaneous unprovoked pain, percussion or palpation pain or other symptoms, indicating of pulpal pathology. Included are carious lesions only on vital teeth, involving up to half of the dentine thickness, with no periodontal pathology. Laser fluorescence diagnosis of adjacent lesions with DIAGNODENT is limited to 20 - 35 scores included. Included are first molars which are not affected by hypoplasia or hypomineralization. Obtained informed consent from parents or gave-givers to participate in the study, in which laser treatment and study procedures are explained in appropriate manner.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elitsa Veneva, DMD
Organizational Affiliation
Medical University - Plovdiv, Bulgaria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Pediatric Dentistry, Faculty of Dental Medicine
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30572467
Citation
Veneva E, Raycheva R, Belcheva A. Efficacy of erbium-doped yttrium aluminium garnet for achieving pre-emptive dental laser analgesia in children: A study protocol for a randomized clinical trial. Medicine (Baltimore). 2018 Dec;97(51):e13601. doi: 10.1097/MD.0000000000013601.
Results Reference
derived

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Effectiveness of Er:YAG Pulse Therapy for Achieving Pre-emptive Dental Analgesia in Children

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