NCT03412721

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Plovdiv Medical University · Academic / Other
• Sex: All
• Age: 10 Years – 12 Years
• Healthy volunteers: Accepted

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.

Conditions

• Caries, Dental

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2018-10-06
• Primary completion: 2019-05-01
• Completion: 2019-09-08
• First posted: 2018-01-26
• Last updated: 2021-06-04

Locations

1 site across 1 country: Bulgaria