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Therapeutic Evaluation of Lower-level Laser for Treating Dentinal Hypersensitivity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03553290
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : June 18, 2018
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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.

Condition or disease Intervention/treatment Phase
Dentinal Hypersensitivity Device: A.R.C. FOX Laser-FOX Q-810nm Procedure: Control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Split-mouth design in the same individual
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: The investigator and outcome assessor were blinded from the arrangement of the treatment
Primary Purpose: Treatment
Official Title: Lower-level Laser for Treating Dentinal Hypersensitivity
Actual Study Start Date : August 10, 2017
Estimated Primary Completion Date : August 31, 2018
Estimated Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

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




Primary Outcome Measures :
  1. Change in mental status [ Time Frame: 6 months ]
    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 :
  1. Change in probing depth [ Time Frame: 6 months ]
    Measure at six surfaces of tooth

  2. Change in clinical attachment level [ Time Frame: 6 months ]
    Measure at six surfaces of tooth

  3. Change in gingival recession [ Time Frame: 6 months ]
    Measure at six surfaces of tooth

  4. Change in masticatory mucosa [ Time Frame: 6 months ]
    Measure at mid-buccal aspect of tooth



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03553290


Contacts
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Contact: Po-Chun Chang 02-23123456 ext 67709 changpc@ntu.edu.tw
Contact: Olivia Hsieh 02-23123456 ext 67704 ling202643@gmail.com

Locations
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Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Po-Chun Chang    02-23123456 ext 67709    changpc@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Po-Chun Chang National Taiwan University Hospital

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03553290    
Other Study ID Numbers: 201701057DIPA
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Taiwan University Hospital:
Dentistry
Dentinal Hypersensitivity
lower-level laser therapy
Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases