Therapeutic Evaluation of Lower-level Laser for Treating Dentinal Hypersensitivity

NCT ID: NCT03553290

Last Updated: 2018-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-10

Study Completion Date

2018-08-31

Brief Summary

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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

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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.

Conditions

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Dentinal Hypersensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Split-mouth design in the same individual
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

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

Study Groups

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control

Mechanical debridement alone

Group Type SHAM_COMPARATOR

Control

Intervention Type PROCEDURE

Mechanical debridement alone

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Control

Mechanical debridement alone

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Po-Chun Chang

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Po-Chun Chang

Role: CONTACT

02-23123456 ext. 67709

Olivia Hsieh

Role: CONTACT

02-23123456 ext. 67704

Facility Contacts

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Po-Chun Chang

Role: primary

02-23123456 ext. 67709

Other Identifiers

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201701057DIPA

Identifier Type: -

Identifier Source: org_study_id

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