Mechanism of Indocyanine Green-based Photodynamic Therapy for Treating Periodontitis

NCT03557827 | Unknown Phase 3 DMC

• 1 other identifier: 201701035MIPA
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal Diseases

Keywords

periodontitis; photodynamic therapy

Outcome Measures

Primary Outcomes (1)

• Change in gingival bleeding index

  Measure at four surfaces of tooth

  6 months

Secondary Outcomes (6)

• Change in probing depth

  6 months

• Change in clinical attachment level

  6 months

• Change in plaque index

  6 months

• Change in IL-1b

  6 months

• Change in gingival crevicular fluid MMP-8

  6 months

Study Arms (2)

control

SHAM COMPARATOR

Mechanical debridement by periodontal curets alone

Procedure: Mechanical debridement alone

Photodynamic Therapy

ACTIVE COMPARATOR

Mechanical debridement by periodontal curets and supplement with photodynamic appliance

Drug: Photodynamic Therapy with indocyanine green and diode laser

Interventions

Photodynamic Therapy with indocyanine green and diode laser DRUG

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

Also known as: EmunDo

Photodynamic Therapy

Mechanical debridement alone PROCEDURE

Mechanical debridement by periodontal curets alone

control

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• With systemic infection
• Taking antibiotics within the past 2 weeks
• Pregnant or lactating
• Current smoker

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Periodontal Diseases; Periodontitis

Interventions

Photochemotherapy; Indocyanine Green; Lasers, Semiconductor

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Po-Chun Chang Chang

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Po-Chun Chang Chang

CONTACT

02-23123456; changpc@ntu.edu.tw

Po-Chun Chang Chang

CONTACT

02-23123456

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigator and outcome assessor were blinded from the arrangement of the treatment
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Split-mouth design. Each quadrant receives different treatment

Study Record Dates

• First Submitted: March 19, 2018
• First Posted: June 15, 2018
• Study Start: March 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: June 15, 2018

Record last verified: 2017-08

Locations

TW (1)