Mechanism of Indocyanine Green-based Photodynamic Therapy for Treating Periodontitis

The aim of this study was to investigate the mechanism of indocyanine green photodynamic therapy (PDT) in periodontal therapy. The investigators will recruit 80 participants receiving conventional periodontal disease treatment, or can not fully accept the regular periodontal treatment of adult periodontal disease, photodynamic therapy, and oral periodontal disease of the teeth as the control group, before treatment , Gingival crevicular fluid and dental plaque were collected at 6 weeks, and 6 months after the treatment. The biochemical indexes and strains were analyzed and the data of the participants Term periodontal index.

In this study, indocyanine photodynamic therapy can improve the discomfort of patients with periodontal disease and the periodontal index, the treatment area of the bacteria and the inflammatory response will be significantly decreased, and look forward to this study can establish the indigo cyanine light dynamic teeth Week therapies to provide periodontal patients with more comfortable and effective clinical therapy.

Study Overview

• Status: Unknown
• Conditions: Periodontal Diseases
• Intervention / Treatment: Procedure: Mechanical debridement alone; Drug: Photodynamic Therapy with indocyanine green and diode laser

Detailed Description

The investigators will recruit 80 adult participants (20 to 80 years old) with periodontal disease who do not receive a regular periodontal course of treatment, or who are unable to receive the regular periodontal treatment completely, using a split-mouth design, meaning that participants are treated with photodynamic therapy of the area for the experimental area, while the mouth corresponding to the location of the area without violations of periodontal disease control area. Participants signed the consent form, the first full-mouth calculus removal and oral hygiene education, and in the experimental area after a week to start photodynamic therapy. The investigators will inject indocyanine in the experimental area, and the wavelength of 810 nm, the energy density of 4.5-9 J / cm2 of the diode laser irradiation; indocyanine and will be cleared after the completion of irradiation, the control area will not For any treatment. After the first treatment, a second, identical treatment will be performed at intervals of 7-10 days. If there is no improvement after 6 weeks, the participant will be treated for the third time.

Participants underwent periodontal examinations in the experimental and control areas at the beginning of the first photodynamic therapy (T0), after six weeks (T1), and six months later (T2), and record the periodontal pocket depth Gingival recession, plaque index and gingivitis index were measured, and the gingival crevicular fluid was obtained by sterilizing the paper needle. The gingival crevicular gingival crevicular gingival crevicular gingival crevicular Fluid, and the use of a periodontal curette to obtain subgingival plaque. The gingival crevicular fluid was quantified using the Periotron 8100 and the concentration of proinflammatory cytokines such as IL-1, IL-10, MMP-8, etc. in the gingival crevicular fluid was analyzed by ELISA kits; DNA was extracted and the periodontal pathogens such as P. gingivalis and T. denticola were detected by Realtime PCR.

In addition, pain assessment was performed with a visual analogue scale at the time of initiation of photodynamic therapy, weekly during the first 6 weeks after initiation of photodynamic therapy, and at 6 months after initiation of treatment . Through these clinical, physiological indicators, as well as the subject experience records, more effective and objective assessment of photodynamic therapy and the establishment of adjuvant therapeutic mechanism.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 3

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion

1. 20-80 year-old with their own will and oral cleaning ability
2. Patients who have been diagnosed with periodontitis and have completed a periodontal treatment for at least three months
3. More than one full-mouth periodontal pocket more than 5 mm or more, and a history of repeated inflammation

Exclusion

1. With systemic infection
2. Taking antibiotics within the past 2 weeks
3. Pregnant or lactating
4. Current smoker

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: control; Mechanical debridement by periodontal curets alone	Procedure: Mechanical debridement alone; Mechanical debridement by periodontal curets alone
Active Comparator: Photodynamic Therapy; Mechanical debridement by periodontal curets and supplement with photodynamic appliance	Drug: Photodynamic Therapy with indocyanine green and diode laser; mechanical debridement by periodontal curets plus Indocyanine green solution activated by diode laser. The diode laser is classified as a Class I medical device according to the Directive 93/42/EEC; Other Names: EmunDo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in gingival bleeding index	Measure at four surfaces of tooth	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in probing depth	Measure at six surfaces of tooth	6 months
Change in clinical attachment level	Measure at six surfaces of tooth	6 months
Change in plaque index	Measure at four surfaces of tooth	6 months
Change in IL-1b	examine the level in the gingival crevicular fluid	6 months
Change in gingival crevicular fluid MMP-8	examine the level in the gingival crevicular fluid	6 months
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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Po-Chun Chang Chang, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: March 19, 2018
• First Submitted That Met QC Criteria: June 4, 2018
• First Posted (Actual): June 15, 2018

Study Record Updates

• Last Update Posted (Actual): June 15, 2018
• Last Update Submitted That Met QC Criteria: June 4, 2018
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: periodontitis; photodynamic therapy
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontitis; Periodontal Diseases
• Other Study ID Numbers: 201701035MIPA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No