PeriodontitisPhase 4NCT02030470
Evaluation of Photodynamic Treatment FOTOSAN® Efficacy in Periodontology
A Phase 4 study testing Fotosan®630. LED lamp. Toluidinblue. Photoactivated disinfection in people with Periodontitis, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Periodontitis
- What is being tested?
- Fotosan®630. LED lamp. Toluidinblue. Photoactivated disinfection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2014to Mar 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Periodontitis
- Being tested
- Fotosan®630. LED lamp. Toluidinblue. Photoactivated disinfection
- Keywords
- Periodontitis, treatment, photodynamic, mid-term, bacteria
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fotosan®630. LED lamp. Toluidinblue. Photoactivated disinfectionOther
| Study group | Role | What they receive |
|---|---|---|
| fotosan | Other | Not described Receives: Other: Fotosan®630. LED lamp. Toluidinblue. Photoactivated disinfection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of periodontal pocket depth
Study period for each participant : 6 months Inclusion period: 24 monthTotal study duration: 30 month
Measured: 6 months
Secondary outcomes (1)
Change of periodontal clinical attachment level, gingival inflammation and dental plaque indexChange of periodontal microflora
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study startJun 2014
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Luc Davideau, MDPHD, Principal investigator, Les Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02030470
- Sponsor's protocol ID
- 5716
- Status last verified
- Jan 2026
- First submitted
- 16 Dec 2013
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31116996Courval 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.
PubMed 32545223
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Photodynamic Treatment FOTOSAN® Efficacy in Periodontology
- ClinicalTrials.gov ID
- NCT02030470
- Acronym / sponsor ID
- 5716
- Conditions
- Periodontitis
- Keywords
- Periodontitis, treatment, photodynamic, mid-term, bacteria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 8 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fotosan | Other | Other: Fotosan®630. LED lamp. Toluidinblue. Photoactivated disinfection |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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%
Key exclusion criteria (12 listed)
- aggressive periodontitis
- smoking more than 10cig/day
- patient with endocarditis risk or need of antibiotic prophylaxis
- pregnant women
- patient included in other trials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fotosan®630. LED lamp. Toluidinblue. Photoactivated disinfection | Other | fotosan |
Primary outcome
Change of periodontal pocket depth
Time frame: 6 months
Study period for each participant : 6 months Inclusion period: 24 monthTotal study duration: 30 month
1 secondary outcome
Change of periodontal clinical attachment level, gingival inflammation and dental plaque indexChange of periodontal microflora
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Results publication: PubMed 31116996Harmouche 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.
- Derived from this study: PubMed 32545223Courval 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Luc Davideau, MDPHD principal investigator
Les Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fotosan®630. LED lamp. Toluidinblue. Photoactivated disinfection in people with Periodontitis, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of periodontal pocket depth (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02030470, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.