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LED Light As An Adjunct Treatment Modality of Periodontal Diseases

Primary Purpose

Periodontal Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
LED appliance during mechanical debridement
LED appliance after mechanical debridement
Mechanical debridement alone
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Diseases focused on measuring chronic periodontitis, light-emitting diodes

Eligibility Criteria

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

inclusion criteria

  1. Over 20 years of age
  2. No pregnancy, major system or chronic disease
  3. Severe periodontitis

exclusion criteria

  1. Age is under 20 years old
  2. Pregnant women
  3. Have a major system or chronic disease
  4. no gingival inflammation or periodontal destruction

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Sham Comparator

Arm Label

LED01

LED02

Control

Arm Description

Conventional non-surgical periodontal therapy plus LED light irradiation from T0-T1

Conventional non-surgical periodontal therapy plus LED light irradiation from T1-T2

Conventional non-surgical periodontal therapy without LED light irradiation

Outcomes

Primary Outcome Measures

Change in probing depth
Measure at six surfaces of tooth

Secondary Outcome Measures

Change in clinical attachment level
Measure at six surfaces of tooth
Change in gingival recession
Measure at six surfaces of tooth
Change in gingival index
Measure at four surfaces of tooth
Change in plaque index
Measure at four surfaces of tooth
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.
Change in IL-1b
examine the level in the gingival crevicular fluid
Change in gingival crevicular fluid MMP-8
examine the level in the gingival crevicular fluid

Full Information

First Posted
June 9, 2017
Last Updated
June 4, 2018
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03557814
Brief Title
LED Light As An Adjunct Treatment Modality of Periodontal Diseases
Official Title
LED Light As An Adjunct Treatment Modality of Periodontal Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
By promoting the cellular activities, it has been shown that the low-level laser therapy (LLLT) is able to accelerate the wound healing, reduce gingival inflammation, relief the discomfort, and serve as an adjunct to the traditional periodontal treatment. As an economic and environmental friendly alternative of the laser, the effect of 660 nm light-emitting diodes (LED) light in facilitating the healing of the oral soft and hard tissue wounds in vivo has been also demonstrated in our previous studies. The aim of this study is to further investigate the feasibility of 660 nm LED light appliance in support of the non-surgical periodontal therapy (NSPT). The LED light appliance will be fabricated by JETTS Technology Co., and the adjunct effect of the LED light on the treatment of periodontitis will be evaluated. Patients with at least one periodontitis-involved teeth in three quadrants will be recruited, and three protocols of LED light irradiation, including LED light irradiation from initial clinical assessment (T0) until the completion of scaling and root planning (T1) (LED01), LED light irradiation from T1 until re-evaluation (T2) (LED02), and no LED light irradiation (control treatment), will be randomly assigned to individual quadrant during the non-surgical periodontal therapy. Clinical parameters will be assessed at T0 and T2, and biomarkers, including IL-1b and MMP-8, from gingival crevicular fluid will be assessed at T0, T1, and T2. It is expected that 660 nm LED light irradiation,regardless of the timing of irradiation, significantly reduce the discomfort of the periodontal treatment, gingival inflammation, and accelerate healing, and hopefully a prototype of LED light appliance for the periodontal treatment could be developed.
Detailed Description
Will recruit 40 volunteers with moderate to advanced periodontal destruction, and all participants will receive 2-3 months full mouth NSPT. Two LED light irradiation protocols will be randomly assigned to two quadrants with periodontitis-infected teeth of each participant. LED01 refers to LED light irradiation once per day from the day of initial clinical assessment (T0) until the completion of ScRP (T1, 4-6 weeks after the first visit). LED02 refers to LED light irradiation once per day from T1 until the day of re-evaluation (T2), and the interval of T1 to T2 was the same as that of T0 to T1. The control treatment refers to no LED light irradiation from T0 until T2. The quadrant without LED light irradiation will be served as control. Each participant will be assigned a cross-arch appliance equipped with the semi-conductors of LED bilaterally (Figure 1B), and the external surface will be covered with aluminum foils to prevent the penetration of the LED light.The irradiation will be controlled by an external controller which will be set to emit 660 nm light with an energy density of 10 J/cm2 or 5 J/cm2 unilaterally. The volunteer will be supervised to use the device every day from T0 to T2. The periodontal examination and the gingival crevicular fluid from the volunteers will be collected at T0, T1, and T2. The volunteers will be also requested to examine the visual analogue scale at these time points. Will evaluate the change of periodontal parameters, the visual analogue scale, and the inflammatory biomarkers (from gingival crevicular fluid), in order to confirm the adjunct therapeutic effect of the LED light device and figure out the most appropriate protocol for the clinical use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases
Keywords
chronic periodontitis, light-emitting diodes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Split-mouth design in the same volunteer. Different quadrant receives different treatment.
Masking
InvestigatorOutcomes Assessor
Masking Description
The investigator and outcome assessor are blinded to the study design
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LED01
Arm Type
Active Comparator
Arm Description
Conventional non-surgical periodontal therapy plus LED light irradiation from T0-T1
Arm Title
LED02
Arm Type
Active Comparator
Arm Description
Conventional non-surgical periodontal therapy plus LED light irradiation from T1-T2
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Conventional non-surgical periodontal therapy without LED light irradiation
Intervention Type
Device
Intervention Name(s)
LED appliance during mechanical debridement
Intervention Description
Mechanical debridement by periodontal curets LED appliance is classified as a Class IIa medical device according to the Directive 93/42/EEC
Intervention Type
Device
Intervention Name(s)
LED appliance after mechanical debridement
Intervention Description
Mechanical debridement by periodontal curets LED appliance is classified as a Class IIa medical device according to the Directive 93/42/EEC
Intervention Type
Device
Intervention Name(s)
Mechanical debridement alone
Intervention Description
Mechanical debridement by periodontal curets alone
Primary Outcome Measure Information:
Title
Change in probing depth
Description
Measure at six surfaces of tooth
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in clinical attachment level
Description
Measure at six surfaces of tooth
Time Frame
12 weeks
Title
Change in gingival recession
Description
Measure at six surfaces of tooth
Time Frame
12 weeks
Title
Change in gingival index
Description
Measure at four surfaces of tooth
Time Frame
12 weeks
Title
Change in plaque index
Description
Measure at four surfaces of tooth
Time Frame
12 weeks
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
12 weeks
Title
Change in IL-1b
Description
examine the level in the gingival crevicular fluid
Time Frame
12 weeks
Title
Change in gingival crevicular fluid MMP-8
Description
examine the level in the gingival crevicular fluid
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
inclusion criteria Over 20 years of age No pregnancy, major system or chronic disease Severe periodontitis exclusion criteria Age is under 20 years old Pregnant women Have a major system or chronic disease no gingival inflammation or periodontal destruction
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Po-Chun Chang
Phone
02-23123456
Ext
67709
Email
changpc@ntu.edu.tw
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
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Po-Chun Chang
Phone
02-23123456
Ext
67709
Email
changpc@ntu.edu.tw

12. IPD Sharing Statement

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LED Light As An Adjunct Treatment Modality of Periodontal Diseases

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