Mechanism of Indocyanine Green-based Photodynamic Therapy for Treating Periodontitis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Mechanism of Indocyanine Green-based Photodynamic Therapy for Treating Periodontitis

Conditions
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Periodontal Diseases

Intervention / Treatment
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* Drug: Photodynamic Therapy with indocyanine green and diode laser
* Procedure: Mechanical debridement alone


Participation Criteria
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Eligibility Criteria
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Inclusion 20-80 year-old with their own will and oral cleaning ability Patients who have been diagnosed with periodontitis and have completed a periodontal treatment for at least three months More than one full-mouth periodontal pocket more than 5 mm or more, and a history of repeated inflammation Exclusion With systemic infection Taking antibiotics within the past 2 weeks Pregnant or lactating Current smoker

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Split-mouth design. Each quadrant receives different treatment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: control<br>Mechanical debridement by periodontal curets alone | Procedure: Mechanical debridement alone<br>* Mechanical debridement by periodontal curets alone<br>|
| Active Comparator: Photodynamic Therapy<br>Mechanical debridement by periodontal curets and supplement with photodynamic appliance | Drug: Photodynamic Therapy with indocyanine green and diode laser<br>* 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<br>* Other names: EmunDo;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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periodontitis, photodynamic therapy