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

A Split-mouth Clinical Study on the Effectiveness of Er:YAG Pulse Therapy for Achieving Pre-emptive Dental Analgesia in Children

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.

Study Overview

• Status: Completed
• Conditions: Caries, Dental
• Intervention / Treatment: Procedure: Laser analgesic procedure; Procedure: Placebo analgesic procedure

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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bulgaria
  • Plovdiv, Bulgaria, 4000
    • Department of Pediatric Dentistry, Faculty of Dental Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laser analgesia; Procedure: Laser analgesic procedure Performing protocol for pre-emptive laser analgesia with Er:YAG laser (Litetouch, Syneron) switched on.	Procedure: Laser analgesic procedure; 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.
Placebo Comparator: Placebo analgesia; Procedure: Placebo analgesic procedure Performing imitation of laser analgesic protocol with Er:YAG laser (Litetouch, Syneron) switched off - no pulse energy applied.	Procedure: Placebo analgesic procedure; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	25 minutes
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').	25 minutes
Patient experience during analgesic or placebo procedure	evaluated by a patient questionnaire	5 minutes
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.	1 hour
Dynamics of the heart rate of the patient	registered throughout the experiment via pulse oximeter	1 hour
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').	1 hour

Collaborators and Investigators

• Sponsor: Plovdiv Medical University
• Investigators: Principal Investigator: Elitsa Veneva, DMD, Medical University - Plovdiv, Bulgaria

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2018
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): September 8, 2019

Study Registration Dates

• First Submitted: January 8, 2018
• First Submitted That Met QC Criteria: January 20, 2018
• First Posted (Actual): January 26, 2018

Study Record Updates

• Last Update Posted (Actual): June 4, 2021
• Last Update Submitted That Met QC Criteria: June 3, 2021
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: pediatric dentistry; laser analgesia
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Analgesics
• Other Study ID Numbers: PlovdivMU

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