Clinical Study of Laser Analgesia in Cavity Preparations Using the Er,Cr:YSGG Laser

NCT03946904 | Completed FDA Device

• 1 other identifier: 18-CHEN-101
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Not much has been done in research to explain the clinical benefit of laser cavity preparation without the use of injection anesthetic. The Author of this study sought to show the science behind the "no shot, no pain" in restorative dentistry using an Er,Cr:YSGG laser Patients with two similar size lesions of class I or class V cavities selected as subjects. In the same appointment, both cavities are prepared by the Er,Cr:YSGG. One lesion was prepared with one high power laser setting to ablate the enamel, dentin, and caries. The other lesion was prepared with a low power setting to start and is aimed at applying low level laser therapy (LLLT) before using the high power setting to ablate enamel, dentin, and caries. A visual analog scale (VAS) was used for the patient to analyze how comfortable each laser technique was. An Analysis of Variance (ANOVA) was used.

Conditions

Tooth Pain

Outcome Measures

Primary Outcomes (1)

• Clinical Study of Laser Analgesia in Cavity Preparations using the Er,Cr:YSGG Laser

  Preconditioning the cavity with LLLT will result in effective analgesia and the cavity preparation will be virtually painless. Overall VAS Score: Up to 3 intra-operative VAS measurements will be recorded. If a patient felt any pain at all during the procedure, they were instructed to raise their hand and the treatment would be paused. The patient was then asked to fill in the VAS form and then the procedure continued. After the conclusion of the cavity preparation, the patients were asked to fill in one last VAS form rating the overall pain of the procedure. Patients that did not raise their hand throughout the entirety of the procedure were given an overall VAS rating of zero. Data for each patient will be recorded and analysed in this way.

  1 year

Study Arms (2)

preconditioning

EXPERIMENTAL

Patients with towo similar size lesions of either Class I or class v cavities selected as subjects. in the same appointment, both cavities are prepared by the Er'Cr:YSGG. The lesion in this case was prepared with low power setting to start and is aimed at applying low level laser therapy (LLLT) first before using high power.

Device: Er,Cr:YSGG Laser

no preconditioning

EXPERIMENTAL

Patients with towo similar size lesions of either Class I or class v cavities selected as subjects. in the same appointment, both cavities are prepared by the Er'Cr:YSGG.the lesion in this case was prepared with high power laser setting first to ablate the enamel, dentin, and caries.

Device: Er,Cr:YSGG Laser

Interventions

Er,Cr:YSGG Laser DEVICE

Patients with towo similar size lesions of either Class I or class v cavities selected as subjects. in the same appointment, both cavities are prepared by the Er'Cr:YSGG. one lesion was prepared with high power laser setting first to ablate the enamel, dentin, and caries. the other lesion was prepared with low power setting to start and is aimed at applying low level laser therapy (LLLT) first before using high power.

Also known as: Iplus laser

no preconditioning; preconditioning

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• You are an adult 19-65 years of age who had at least two cavity preparations of the same type, with the same approximate size lesion.
• No language barriers
• Not Pregnant
• Immune system is not compromised (No bronchitis, no sinus infection, no ear infection, or any other infection of any type ect…)
• No Heart Disease
• No high blood pressure
• No teeth amalgam restorations were in close proximity to the lesion.
• Requiring at least two cavity preparations of the same type, with the same approximate size of lesion (minimum 1mm diameter x 1mm depth).

You may not qualify if:

• Children
• Pregnant women
• Immune compromised patients
• Patients with heart disease
• High blood pressure
• Cardiac arrhythmia
• Patients whose teeth amalgam restorations were in close proximity to the lesion
• Decay that has reached the pulp where potential for root canal therapy
• Patients of different language difficulty

Sponsors & Collaborators

• Chen Laser Institute: lead

Study Sites (1)

Chen Laser Institute

Granite City, Illinois, 62040, United States

Location

MeSH Terms

Conditions

Toothache

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• William H Chen, doctor

  Chen Laser Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2019
• First Posted: May 13, 2019
• Study Start: December 18, 2018
• Primary Completion: April 15, 2019
• Study Completion: April 15, 2019
• Last Updated: May 13, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)