Evaluation of Photodynamic Treatment FOTOSAN® Efficacy in Periodontology

August 19, 2019 updated by: University Hospital, Strasbourg, France
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Alsace
      • Strasbourg, Alsace, France, 67000
        • Service de parodontologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: fotosan
Other: Fotosan®630. LED lamp. Toluidinblue. Photoactivated disinfection

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Change of periodontal clinical attachment level, gingival inflammation and dental plaque indexChange of periodontal microflora
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: Jean-Luc Davideau, MDPHD, Les Hôpitaux Universitaires de Strasbourg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2014

Primary Completion (ACTUAL)

March 1, 2018

Study Completion (ACTUAL)

March 1, 2018

Study Registration Dates

First Submitted

December 16, 2013

First Submitted That Met QC Criteria

January 6, 2014

First Posted (ESTIMATE)

January 8, 2014

Study Record Updates

Last Update Posted (ACTUAL)

August 20, 2019

Last Update Submitted That Met QC Criteria

August 19, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5716

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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