Therapeutic Evaluation of Lower-level Laser for Treating Dentinal Hypersensitivity

Lower-level Laser for Treating Dentinal Hypersensitivity

The aim of this study was to evaluate the efficacy of low energy laser for the treatment of dentinal hypersensitivity due to periodontal therapy.

Study Overview

• Status: Unknown
• Conditions: Dentinal Hypersensitivity
• Intervention / Treatment: Procedure: Control; Device: A.R.C. FOX Laser-FOX Q-810nm

Detailed Description

We will recruit 80 adult patients with obvious symptom of hypersensitivity after periodontal therapy. They will receive low-energy laser treatment, and the area without the symptom of hypersensitivity will be served as control. Changes in pain status and clinical periodontal index within six months of treatment will be recorded.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria

1.20-80 year-old with their own will and oral cleaning ability 2.Patients who have been diagnosed with periodontitis and have completed periodontal treatment 3.Gingival recession in at least two regions showed sensitivity of teeth (VAS> 5) 4.No systemic infection 5.No painkillers in the past two weeks 6.Not pregnant or lactating

Exclusion criteria

1.Smoking more than half a pack a day in the past month

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
SHAM_COMPARATOR: control; Mechanical debridement alone	Procedure: Control; Mechanical debridement alone
ACTIVE_COMPARATOR: lower-level laser Therapy; Mechanical debridement with lower-level laser therapy Device: A.R.C. FOX Laser-FOX Q-810nm Mechanical debridement with lower-level laser therapy	Device: A.R.C. FOX Laser-FOX Q-810nm; 805-810 nm dichotomous laser, 12 Watt within the power of sensitive parts of the affected teeth

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mental status	Visual analogue scale analysis with a score range of 0-10 (0: no discomfort; 10: severe discomfort). Lower score represent a better outcome.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in probing depth	Measure at six surfaces of tooth	6 months
Change in clinical attachment level	Measure at six surfaces of tooth	6 months
Change in gingival recession	Measure at six surfaces of tooth	6 months
Change in masticatory mucosa	Measure at mid-buccal aspect of tooth	6 months

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 10, 2017
• Primary Completion (ANTICIPATED): August 31, 2018
• Study Completion (ANTICIPATED): August 31, 2018

Study Registration Dates

• First Submitted: August 15, 2017
• First Submitted That Met QC Criteria: June 11, 2018
• First Posted (ACTUAL): June 12, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 18, 2018
• Last Update Submitted That Met QC Criteria: June 15, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Dentistry; Dentinal Hypersensitivity; lower-level laser therapy
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: 201701057DIPA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No