Therapeutic Evaluation of Lower-level Laser for Treating Dentinal Hypersensitivity

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to evaluate the efficacy of low energy laser for the treatment of dentinal hypersensitivity due to periodontal therapy.

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.

Official Title
-----------------
Lower-level Laser for Treating Dentinal Hypersensitivity

Conditions
-----------------
Dentinal Hypersensitivity

Intervention / Treatment
-----------------
* Device: A.R.C. FOX Laser-FOX Q-810nm
* Procedure: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Split-mouth design in the same individual
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: control<br>Mechanical debridement alone | Procedure: Control<br>* Mechanical debridement alone<br>|
| Active Comparator: lower-level laser Therapy<br>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<br>* 805-810 nm dichotomous laser, 12 Watt within the power of sensitive parts of the affected teeth<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dentistry, Dentinal Hypersensitivity, lower-level laser therapy