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Therapeutic Evaluation of Lower-level Laser for Treating Dentinal Hypersensitivity

Primary Purpose

Dentinal Hypersensitivity

Status

Unknown status

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

A.R.C. FOX Laser-FOX Q-810nm

Control

About this trial

This is an interventional treatment trial for Dentinal Hypersensitivity focused on measuring Dentistry, Dentinal Hypersensitivity, lower-level laser therapy

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

control

lower-level laser Therapy

Arm Description

Mechanical debridement alone

Mechanical debridement with lower-level laser therapy Device: A.R.C. FOX Laser-FOX Q-810nm Mechanical debridement with lower-level laser therapy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in probing depth

Measure at six surfaces of tooth

Change in clinical attachment level

Measure at six surfaces of tooth

Change in gingival recession

Measure at six surfaces of tooth

Change in masticatory mucosa

Measure at mid-buccal aspect of tooth

Full Information

NCT ID

NCT03553290

First Posted

August 15, 2017

Last Updated

June 15, 2018

Sponsor

National Taiwan University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03553290

Brief Title

Therapeutic Evaluation of Lower-level Laser for Treating Dentinal Hypersensitivity

Official Title

Lower-level Laser for Treating Dentinal Hypersensitivity

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Unknown status

Study Start Date

August 10, 2017 (Actual)

Primary Completion Date

August 31, 2018 (Anticipated)

Study Completion Date

August 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dentinal Hypersensitivity

Keywords

Dentistry, Dentinal Hypersensitivity, lower-level laser therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Split-mouth design in the same individual

Masking

InvestigatorOutcomes Assessor

Masking Description

The investigator and outcome assessor were blinded from the arrangement of the treatment

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

control

Arm Type

Sham Comparator

Arm Description

Mechanical debridement alone

Arm Title

lower-level laser Therapy

Arm Type

Active Comparator

Arm Description

Mechanical debridement with lower-level laser therapy Device: A.R.C. FOX Laser-FOX Q-810nm Mechanical debridement with lower-level laser therapy

Intervention Type

Device

Intervention Name(s)

A.R.C. FOX Laser-FOX Q-810nm

Intervention Description

805-810 nm dichotomous laser, 12 Watt within the power of sensitive parts of the affected teeth

Intervention Type

Procedure

Intervention Name(s)

Control

Intervention Description

Mechanical debridement alone

Primary Outcome Measure Information:

Title

Change in mental status

Description

Visual analogue scale analysis with a score range of 0-10 (0: no discomfort; 10: severe discomfort). Lower score represent a better outcome.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Change in probing depth

Description

Measure at six surfaces of tooth

Time Frame

6 months

Title

Change in clinical attachment level

Description

Measure at six surfaces of tooth

Time Frame

6 months

Title

Change in gingival recession

Description

Measure at six surfaces of tooth

Time Frame

6 months

Title

Change in masticatory mucosa

Description

Measure at mid-buccal aspect of tooth

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Po-Chun Chang

Phone

02-23123456

Ext

67709

changpc@ntu.edu.tw

First Name & Middle Initial & Last Name or Official Title & Degree

Olivia Hsieh

Phone

02-23123456

Ext

67704

ling202643@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Po-Chun Chang

Organizational Affiliation

National Taiwan University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Taiwan University Hospital

City

Taipei

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Po-Chun Chang

Phone

02-23123456

Ext

67709

changpc@ntu.edu.tw

12. IPD Sharing Statement

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Therapeutic Evaluation of Lower-level Laser for Treating Dentinal Hypersensitivity

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