LED Light As An Adjunct Treatment Modality of Periodontal Diseases

NCT03557814 | Unknown DMC

• 1 other identifier: 201508099DIPC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal Diseases

Keywords

chronic periodontitis; light-emitting diodes

Outcome Measures

Primary Outcomes (1)

• Change in probing depth

  Measure at six surfaces of tooth

  12 weeks

Secondary Outcomes (7)

• Change in clinical attachment level

  12 weeks

• Change in gingival recession

  12 weeks

• Change in gingival index

  12 weeks

• Change in plaque index

  12 weeks

• Change in mental status

  12 weeks

Study Arms (3)

LED01

ACTIVE COMPARATOR

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

Device: LED appliance during mechanical debridement

LED02

ACTIVE COMPARATOR

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

Device: LED appliance after mechanical debridement

Control

SHAM COMPARATOR

Conventional non-surgical periodontal therapy without LED light irradiation

Device: Mechanical debridement alone

Interventions

LED appliance during mechanical debridement DEVICE

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

LED01

LED appliance after mechanical debridement DEVICE

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

LED02

Mechanical debridement alone DEVICE

Mechanical debridement by periodontal curets alone

Control

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 20 years of age
• No pregnancy, major system or chronic disease
• Severe periodontitis

You may not qualify if:

• Age is under 20 years old
• Pregnant women
• Have a major system or chronic disease
• no gingival inflammation or periodontal destruction

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Periodontal Diseases; Chronic Periodontitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Periodontitis; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Po-Chun Chang

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Po-Chun Chang

CONTACT

02-23123456; changpc@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigator and outcome assessor are blinded to the study design
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Split-mouth design in the same volunteer. Different quadrant receives different treatment.

Study Record Dates

• First Submitted: June 9, 2017
• First Posted: June 15, 2018
• Study Start: September 1, 2017
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: June 15, 2018

Record last verified: 2017-06

Locations

TW (1)