Therapeutic Evaluation of Lower-level Laser for Treating Dentinal Hypersensitivity
Lower-level Laser for Treating Dentinal Hypersensitivity
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 10, 2017
CompletedFirst Submitted
Initial submission to the registry
August 15, 2017
CompletedFirst Posted
Study publicly available on registry
June 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2018
CompletedJune 18, 2018
March 1, 2018
1.1 years
August 15, 2017
June 15, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Change in probing depth
6 months
Change in clinical attachment level
6 months
Change in gingival recession
6 months
Change in masticatory mucosa
6 months
Study Arms (2)
control
SHAM COMPARATORMechanical debridement alone
lower-level laser Therapy
ACTIVE COMPARATORMechanical debridement with lower-level laser therapy Device: A.R.C. FOX Laser-FOX Q-810nm Mechanical debridement with lower-level laser therapy
Interventions
805-810 nm dichotomous laser, 12 Watt within the power of sensitive parts of the affected teeth
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Smoking more than half a pack a day in the past month
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, Taiwan
Study Officials
- PRINCIPAL INVESTIGATOR
Po-Chun Chang
National Taiwan University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The investigator and outcome assessor were blinded from the arrangement of the treatment
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 15, 2017
First Posted
June 12, 2018
Study Start
August 10, 2017
Primary Completion
August 31, 2018
Study Completion
August 31, 2018
Last Updated
June 18, 2018
Record last verified: 2018-03