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Evaluation of Photodynamic Treatment FOTOSAN® Efficacy in Periodontology

Primary Purpose

Periodontitis

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Fotosan®630. LED lamp. Toluidinblue. Photoactivated disinfection
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring Periodontitis, treatment, photodynamic, mid-term, bacteria

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • aged 40 years
  • signed informed consent
  • generalized severe chronic periodontitis
  • patient with at least 24 teeth
  • more than 30% of sites with clinical attachment loss >5mm- at least 5 sites with pocket depth >4mm per quadrant- at least one molar per quadrant- evidenced bone loss on radiographs- bleeding on probing ≥30%

Exclusion Criteria:

  • aggressive periodontitis
  • smoking more than 10cig/day
  • patient with endocarditis risk or need of antibiotic prophylaxis
  • pregnant women
  • patient included in other trials
  • patient under guardianship
  • patient treated with antibiotics, anti-inflammatory, and other drugs (inhibitors of calcium channels…) influencing periodontal status within 6 months before examination
  • patient suffering from diseases influencing periodontal status (diabetes…)
  • patient periodontally treated with root planing or periodontal surgery within 1 year before examination
  • patient with scheduled extensive prosthetic treatment
  • patient with a high haemorrhagic risk (INR>4)
  • impossible patient cooperation

Sites / Locations

  • Service de parodontologie

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

fotosan

Arm Description

Outcomes

Primary Outcome Measures

Change of periodontal pocket depth
Study period for each participant : 6 months Inclusion period: 24 monthTotal study duration: 30 month

Secondary Outcome Measures

Change of periodontal clinical attachment level, gingival inflammation and dental plaque indexChange of periodontal microflora

Full Information

First Posted
December 16, 2013
Last Updated
August 19, 2019
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT02030470
Brief Title
Evaluation of Photodynamic Treatment FOTOSAN® Efficacy in Periodontology
Official Title
Evaluation of Photodynamic Treatment FOTOSAN® Efficacy in Periodontology
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
June 2014 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Periodontitis are infectious and inflammatory diseases of gum and tooth supporting tissues leading to tooth loss and oral disability. Twenty to 30 percents of patients treated for periodontal diseases display more or less pronounced persistence of periodontal tissue infection, inflammation, and destruction. The therapeutic additional value of photodynamic anti-infectious treatment remains controversial. The objective of this study is to evaluate the mid-term effect of the photodynamic device Fotosan®630 on severe periodontitis treatment outcomes and to define its specific therapeutic indications.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
Keywords
Periodontitis, treatment, photodynamic, mid-term, bacteria

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
fotosan
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Fotosan®630. LED lamp. Toluidinblue. Photoactivated disinfection
Primary Outcome Measure Information:
Title
Change of periodontal pocket depth
Description
Study period for each participant : 6 months Inclusion period: 24 monthTotal study duration: 30 month
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change of periodontal clinical attachment level, gingival inflammation and dental plaque indexChange of periodontal microflora
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: aged 40 years signed informed consent generalized severe chronic periodontitis patient with at least 24 teeth more than 30% of sites with clinical attachment loss >5mm- at least 5 sites with pocket depth >4mm per quadrant- at least one molar per quadrant- evidenced bone loss on radiographs- bleeding on probing ≥30% Exclusion Criteria: aggressive periodontitis smoking more than 10cig/day patient with endocarditis risk or need of antibiotic prophylaxis pregnant women patient included in other trials patient under guardianship patient treated with antibiotics, anti-inflammatory, and other drugs (inhibitors of calcium channels…) influencing periodontal status within 6 months before examination patient suffering from diseases influencing periodontal status (diabetes…) patient periodontally treated with root planing or periodontal surgery within 1 year before examination patient with scheduled extensive prosthetic treatment patient with a high haemorrhagic risk (INR>4) impossible patient cooperation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Luc Davideau, MDPHD
Organizational Affiliation
Les Hôpitaux Universitaires de Strasbourg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de parodontologie
City
Strasbourg
State/Province
Alsace
ZIP/Postal Code
67000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
32545223
Citation
Courval A, Harmouche L, Mathieu A, Petit C, Huck O, Severac F, Davideau JL. Impact of Molar Furcations on Photodynamic Therapy Outcomes: A 6-Month Split-Mouth Randomized Clinical Trial. Int J Environ Res Public Health. 2020 Jun 11;17(11):4162. doi: 10.3390/ijerph17114162.
Results Reference
derived

Learn more about this trial

Evaluation of Photodynamic Treatment FOTOSAN® Efficacy in Periodontology

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