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OpenTrials
Completed

NCT Number: NCT02030470

Evaluation of Photodynamic Treatment FOTOSAN® Efficacy in Periodontology

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.

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Service de parodontologie

Strasbourg, Alsace, 67000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fotosan®630. LED lamp. Toluidinblue. Photoactivated disinfection

Other

Primary outcomes

  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 outcomes

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

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jan 8, 2014
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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