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Evaluation of Photodynamic Treatment FOTOSAN® Efficacy in Periodontology

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ClinicalTrials.gov Identifier: NCT02030470
Recruitment Status : Completed
First Posted : January 8, 2014
Last Update Posted : August 27, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

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.

Condition or disease Intervention/treatment Phase
Periodontitis Other: Fotosan®630. LED lamp. Toluidinblue. Photoactivated disinfection Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Evaluation of Photodynamic Treatment FOTOSAN® Efficacy in Periodontology
Actual Study Start Date : June 2014
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Arm Intervention/treatment
fotosan Other: Fotosan®630. LED lamp. Toluidinblue. Photoactivated disinfection



Primary Outcome Measures :
  1. Change of periodontal pocket depth [ Time Frame: 6 months ]
    Study period for each participant : 6 months Inclusion period: 24 monthTotal study duration: 30 month


Secondary Outcome Measures :
  1. Change of periodontal clinical attachment level, gingival inflammation and dental plaque indexChange of periodontal microflora [ Time Frame: 6 months ]


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02030470


Locations
France
Service de parodontologie
Strasbourg, Alsace, France, 67000
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Jean-Luc Davideau, MDPHD Les Hôpitaux Universitaires de Strasbourg

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT02030470     History of Changes
Other Study ID Numbers: 5716
First Posted: January 8, 2014    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018

Keywords provided by University Hospital, Strasbourg, France:
Periodontitis, treatment, photodynamic, mid-term, bacteria

Additional relevant MeSH terms:
Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases