Clinical trial NCT03557827: Mechanism of Indocyanine Green-based Photodynamic Therapy for Treating Periodontitis
Official title: Mechanism of Indocyanine Green-based Photodynamic Therapy for Treating Periodontitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Periodontal Diseases
Keywords: periodontitis
photodynamic therapy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2018-06-15
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Split-mouth design. Each quadrant receives different treatment
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in gingival bleeding index
timeFrame: 6 months
Secondary outcomes:
measure: Change in probing depth
timeFrame: 6 months
measure: Change in clinical attachment level
timeFrame: 6 months
measure: Change in plaque index
timeFrame: 6 months
measure: Change in IL-1b
timeFrame: 6 months
measure: Change in gingival crevicular fluid MMP-8
timeFrame: 6 months
measure: Change in mental status
timeFrame: 6 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Po-Chun Chang Chang
role: PRINCIPAL_INVESTIGATOR
References: