NCT02030470

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2014

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2013

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 8, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

3.8 years

First QC Date

December 16, 2013

Last Update Submit

January 16, 2026

Conditions

Periodontitis

Keywords

Periodontitis, treatment, photodynamic, mid-term, bacteria

Outcome Measures

Primary Outcomes (1)

  • Change of periodontal pocket depth

    Study period for each participant : 6 months Inclusion period: 24 monthTotal study duration: 30 month

    6 months

Secondary Outcomes (1)

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

    6 months

Study Arms (1)

fotosan

OTHER
Other: Fotosan®630. LED lamp. Toluidinblue. Photoactivated disinfection

Interventions

Fotosan®630. LED lamp. Toluidinblue. Photoactivated disinfectionOTHER
fotosan

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de parodontologie

Strasbourg, Alsace, 67000, France

Location

Related Publications (2)

  • Harmouche L, Courval A, Mathieu A, Petit C, Huck O, Severac F, Davideau JL. Impact of tooth-related factors on photodynamic therapy effectiveness during active periodontal therapy: A 6-months split-mouth randomized clinical trial. Photodiagnosis Photodyn Ther. 2019 Sep;27:167-172. doi: 10.1016/j.pdpdt.2019.05.022. Epub 2019 May 19.

    PMID: 31116996RESULT

  • 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.

    PMID: 32545223DERIVED

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Jean-Luc Davideau, MDPHD

    Les Hôpitaux Universitaires de Strasbourg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2013

First Posted

January 8, 2014

Study Start

June 1, 2014

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

January 20, 2026

Record last verified: 2026-01

Locations

FR(1)