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

NCT03412721 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2021-06-04

No results posted yet for this study

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.

Conditions

  • Caries, Dental

Interventions

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.

Sponsors & Collaborators

  • Plovdiv Medical University

    lead OTHER

Principal Investigators

  • Elitsa Veneva, DMD · Medical University - Plovdiv, Bulgaria

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
10 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-06
Primary Completion
2019-05-01
Completion
2019-09-08

Countries

  • Bulgaria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03412721 on ClinicalTrials.gov