NCT03553290

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

August 15, 2017

Completed
10 months until next milestone

First Posted

Study publicly available on registry

June 12, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
Last Updated

June 18, 2018

Status Verified

March 1, 2018

Enrollment Period

1.1 years

First QC Date

August 15, 2017

Last Update Submit

June 15, 2018

Conditions

Keywords

DentistryDentinal Hypersensitivitylower-level laser therapy

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 COMPARATOR

Mechanical debridement alone

Procedure: Control

lower-level laser Therapy

ACTIVE COMPARATOR

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

Interventions

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

lower-level laser Therapy
ControlPROCEDURE

Mechanical debridement alone

control

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

RECRUITING

Study Officials

  • Po-Chun Chang

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

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
Model Details: Split-mouth design in the same individual
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

Locations