Periodontal Diseases Clinical Trial
Official title:
LED Light As An Adjunct Treatment Modality of Periodontal Diseases
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | August 31, 2018 |
Est. primary completion date | August 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Taiwan | National Taiwan University Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in probing depth | Measure at six surfaces of tooth | 12 weeks | |
Secondary | Change in clinical attachment level | Measure at six surfaces of tooth | 12 weeks | |
Secondary | Change in gingival recession | Measure at six surfaces of tooth | 12 weeks | |
Secondary | Change in gingival index | Measure at four surfaces of tooth | 12 weeks | |
Secondary | Change in plaque index | Measure at four surfaces of tooth | 12 weeks | |
Secondary | 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. | 12 weeks | |
Secondary | Change in IL-1b | examine the level in the gingival crevicular fluid | 12 weeks | |
Secondary | Change in gingival crevicular fluid MMP-8 | examine the level in the gingival crevicular fluid | 12 weeks |
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