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Mechanism of Indocyanine Green-based Photodynamic Therapy for Treating Periodontitis

Primary Purpose

Periodontal Diseases

Status
Unknown status
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
Photodynamic Therapy with indocyanine green and diode laser
Mechanical debridement alone
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Diseases focused on measuring periodontitis, photodynamic therapy

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

control

Photodynamic Therapy

Arm Description

Mechanical debridement by periodontal curets alone

Mechanical debridement by periodontal curets and supplement with photodynamic appliance

Outcomes

Primary Outcome Measures

Change in gingival bleeding index
Measure at four surfaces of tooth

Secondary Outcome Measures

Change in probing depth
Measure at six surfaces of tooth
Change in clinical attachment level
Measure at six surfaces of tooth
Change in plaque index
Measure at four surfaces of tooth
Change in IL-1b
examine the level in the gingival crevicular fluid
Change in gingival crevicular fluid MMP-8
examine the level in the gingival crevicular fluid
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.

Full Information

First Posted
March 19, 2018
Last Updated
June 4, 2018
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03557827
Brief Title
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

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases
Keywords
periodontitis, photodynamic therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
Split-mouth design. Each quadrant receives different treatment
Masking
InvestigatorOutcomes Assessor
Masking Description
The investigator and outcome assessor were blinded from the arrangement of the treatment
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
Sham Comparator
Arm Description
Mechanical debridement by periodontal curets alone
Arm Title
Photodynamic Therapy
Arm Type
Active Comparator
Arm Description
Mechanical debridement by periodontal curets and supplement with photodynamic appliance
Intervention Type
Drug
Intervention Name(s)
Photodynamic Therapy with indocyanine green and diode laser
Other Intervention Name(s)
EmunDo
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Mechanical debridement alone
Intervention Description
Mechanical debridement by periodontal curets alone
Primary Outcome Measure Information:
Title
Change in gingival bleeding index
Description
Measure at four surfaces of tooth
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in probing depth
Description
Measure at six surfaces of tooth
Time Frame
6 months
Title
Change in clinical attachment level
Description
Measure at six surfaces of tooth
Time Frame
6 months
Title
Change in plaque index
Description
Measure at four surfaces of tooth
Time Frame
6 months
Title
Change in IL-1b
Description
examine the level in the gingival crevicular fluid
Time Frame
6 months
Title
Change in gingival crevicular fluid MMP-8
Description
examine the level in the gingival crevicular fluid
Time Frame
6 months
Title
Change in mental status
Description
Visual analogue scale analysis with a score range of 0-10 (0: no discomfort; 10: severe discomfort). Lower score represent a better outcome.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Po-Chun Chang Chang
Phone
02-23123456
Ext
67709
Email
changpc@ntu.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Po-Chun Chang Chang
Phone
02-23123456
Ext
67709
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Po-Chun Chang Chang
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Po-Chun Chang
Phone
02-23123456
Ext
67709
Email
changpc@ntu.edu.tw

12. IPD Sharing Statement

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Mechanism of Indocyanine Green-based Photodynamic Therapy for Treating Periodontitis

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