Mechanism of Indocyanine Green-based Photodynamic Therapy for Treating Periodontitis

Periodontal Diseases Clinical Trial

Official title:

Mechanism of Indocyanine Green-based Photodynamic Therapy for Treating Periodontitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03557827
• Other study ID #: 201701035MIPA
• Status: Recruiting
• Phase: Phase 3
• Start date: March 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: August 2017
• Source: National Taiwan University Hospital
• Contact: Po-Chun Chang Chang
• Phone: 02-23123456
• Email: changpc[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Gingival Diseases
• Periodontal Diseases
• Periodontitis

Intervention

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

Procedure:
• Mechanical debridement alone
Mechanical debridement by periodontal curets alone

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in gingival bleeding index	Measure at four surfaces of tooth	6 months
Secondary	Change in probing depth	Measure at six surfaces of tooth	6 months
Secondary	Change in clinical attachment level	Measure at six surfaces of tooth	6 months
Secondary	Change in plaque index	Measure at four surfaces of tooth	6 months
Secondary	Change in IL-1b	examine the level in the gingival crevicular fluid	6 months
Secondary	Change in gingival crevicular fluid MMP-8	examine the level in the gingival crevicular fluid	6 months
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.	6 months