LED Light As An Adjunct Treatment Modality of Periodontal Diseases

NCT ID: NCT03557814

Last Updated: 2018-06-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2018-08-31

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.

Conditions

Periodontal Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

LED01

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

Group Type: ACTIVE_COMPARATOR

LED appliance during mechanical debridement

Intervention Type: DEVICE

Mechanical debridement by periodontal curets LED appliance is classified as a Class IIa medical device according to the Directive 93/42/EEC

LED02

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

Group Type: ACTIVE_COMPARATOR

LED appliance after mechanical debridement

Intervention Type: DEVICE

Mechanical debridement by periodontal curets LED appliance is classified as a Class IIa medical device according to the Directive 93/42/EEC

Control

Conventional non-surgical periodontal therapy without LED light irradiation

Group Type: SHAM_COMPARATOR

Mechanical debridement alone

Intervention Type: DEVICE

Mechanical debridement by periodontal curets alone

Interventions

LED appliance during mechanical debridement

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

LED appliance after mechanical debridement

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

Mechanical debridement alone

Mechanical debridement by periodontal curets alone

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Po-Chun Chang

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Po-Chun Chang

Role: CONTACT

changpc@ntu.edu.tw

02-23123456 ext. 67709

Facility Contacts

Po-Chun Chang

Role: primary

changpc@ntu.edu.tw

02-23123456 ext. 67709

Other Identifiers

201508099DIPC

Identifier Type: -

Identifier Source: org_study_id