Periodontal DiseasesPhase 2NCT03855345
Antimicrobial Photodynamic Therapy Mediated by PapaMBlue® on Chronic Periodontal Disease
A Phase 2 study testing Conventional treatment and aPDT in people with Periodontal Diseases, run by University of Nove de Julho.
Trial summary
The elimination of the pathogenic microorganisms of the periodontal pocket is one of the main points for success in periodontal treatment. The objective of this study is to investigate the clinical and antimicrobial effect of papain-mediated photodynamic therapy in the clinical treatment of periodontal disease. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- Conventional treatment and aPDT
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2019to 15 Apr 2020
- Phase
- Phase 2
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must have chronic periodontitis (AAP, 2001);
- At least 10 present teeth, with at least 3 sites with clinical depth of probing greater than 4 mm;
- The patient must be in periodontal treatment at the Dental Clinic of Universidade Nove de Julho, institution where this research will be carried out;
Who cannot join
- Smokers or former smokers who discontinued the habit less than 12 months prior to selection;
- Uncontrolled diabetes;
- Anemia;
- Cancer;
- Pregnant women;
- Use of antibiotics in the last 6 months;
Show all 10Show fewer
- Use of anti-inflammatory in the last 3 months;
- Coagulation disorder (use of anti-coagulant, presence of liver diseases, thrombocytopenia and immunosuppression);
- Patients under orthodontic treatment;
- Patients who maintain a biofilm index greater than 25%.
About this study
Official title: Antimicrobial Photodynamic Therapy Mediated by PapaMBlue® on Chronic Periodontal Disease - Randomized Blind Controlled Trial
The elimination of the pathogenic microorganisms of the periodontal pocket is one of the main points for success in periodontal treatment. The objective of this study is to investigate the clinical and antimicrobial effect of papain-mediated photodynamic therapy in the clinical treatment of periodontal disease. Twenty patients with chronic periodontitis will be selected. Patients will be divided randomly into two groups (n = 10), and the control group will receive conventional periodontal treatment and group II will receive conventional treatment and antimicrobial photodynamic therapy (aPDT). Conventional treatment will consist of oral hygiene guidance, with brushing technique instructions and recommendation of daily flossing. The calculus deposits on the teeth will be removed with ultrasound equipment and curettes for scraping and root planing. The aPDT will be performed at the end of each periodontal treatment session, at sites with bags greater than or equal to 4 mm. The PapaMblue® photosensitizer will be deposited in the periodontal pockets with a syringe and a pre-irradiation time of 1 min will be adopted. Then, the laser emitting wavelength of 660 nm, with power of 100 mW, for 2 min, radiant exposure of 30 J/cm2 and power density of 250 mW/cm2 will be applied. Patients will undergo clinical evaluations before treatment (day 1) and 30, 60 and 90 days after the end of treatment. Microbiological evaluations will be made before and 30 days after treatment. The distribution of the data within each group and the homogeneity of the variances will be verified. With this information, the most appropriate statistical test for each evaluation will be used. The sample calculation is based on the literature and the significance level of 5% will be adopted.
- Conditions
- Periodontal Diseases
- Being tested
- Conventional treatment, aPDT
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional treatmentProcedure or surgery
The treatment will consist of oral hygiene orientation, with instructions of brushing technique and recommendation of the daily use of dental floss. All patients will receive a demonstration of oral hygiene techniques. The calculus deposits on the teeth will be removed with ultrasound equipment and curettes for root scaling and straightening. After the use of ultrasound and curettes, bicarbonate jet will be used to remove dental biofilm. Treatment will be performed in 2 to 4 sessions under local anesthesia (typically 2% mepivacaine with 1: 100,000 noradrenaline). Gracey periodontal curettes (numbers 3/4, 7/8, 11/12 and 13/14) and Mc Call curettes for removal of the dental calculus will be used. Other biofilm-retaining factors, such as carious lesions, condemned teeth, and ill-adapted restorations, will be removed during these periodontal treatment sessions.
aPDTRadiation
aPDT will be performed at the end of each periodontal treatment session, at sites with bags greater than or equal to 4 mm. The photosensitizer PapaMBlue® (F \& A Ltda, São Paulo, Brazil) will be deposited in the pouches with a syringe, with the application in coronal direction, and a time of 1 min of pre-irradiation will be adopted so that the substance can stain bacterial biofilm (according to the manufacturer's information). Next, the diode laser emitting wavelength of ʎ=660 nm, with power of P=100 mW, will be applied. The laser will be applied to the mucosa, over the oral epithelium with an optical fiber. Irradiation will be performed until the entire periodontal pocket is illuminated for 2 min at each point. Each irradiation point will be approximately 0.4cm2, which will result in energy density of 30 J/cm2 in 2 min irradiation. The irradiation will have a constant power density of 250 mW/cm2.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Experimental | In this group, the participants will be submitted to the conventional treatment. The treatment will consist of oral hygiene orientation, with instructions of brushing technique and recommendation of the daily use of dental floss. All patients will receive a demonstration of oral hygiene techniques. The calculus deposits on the teeth will be removed with ultrasound equipment and curettes for root scaling and straightening. After the use of ultrasound and curettes, bicarbonate jet will be used to remove dental biofilm. Treatment will be performed in 2 to 4 sessions under local anesthesia (typically 2% mepivacaine with 1: 100,000 noradrenaline). Gracey periodontal curettes (numbers 3/4, 7/8, 11/12 and 13/14) and Mc Call curettes for removal of the dental calculus will be used. Other biofilm-retaining factors, such as carious lesions, condemned teeth, and ill-adapted restorations, will be removed during these periodontal treatment sessions. Receives: Procedure: Conventional treatment |
| aPDT group | Experimental | In this group, besides the conventional treatments, patients will also receive aPDT. aPDT will be performed at the end of each periodontal treatment session, at sites with bags greater than or equal to 4 mm. The photosensitizer PapaMBlue® (F \& A Ltda, São Paulo, Brazil) will be deposited in the pouches with a syringe, with the application in coronal direction, and a time of 1 min of pre-irradiation will be adopted so that the substance can stain bacterial biofilm (according to the manufacturer's information). Next, the diode laser emitting wavelength of ʎ=660 nm, with power of P=100 mW, will be applied. The laser will be applied to the mucosa, over the oral epithelium with an optical fiber. Irradiation will be performed until the entire periodontal pocket is illuminated for 2 min at each point. Each irradiation point will be approximately 0.4cm2, which will result in energy density of 30 J/cm2 in 2 min irradiation. The irradiation will have a constant power density of 250 mW/cm2. Receives: Procedure: Conventional treatment; Radiation: aPDT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in probing depth
For the evaluation of probing depth, a single trained, calibrated examiner will examine 6 sites of each tooth with a 15mm North Carolina millimeter probe (Hu-Friedy, Chicago, IL, USA) for the measurement of probing depth in milimeters. The evaluation will be performed at the beginning of treatment, 30, 60 and 90 days after the tretaments.
Measured: Baseline, 30, 60 and 90 days after treatment.
Secondary outcomes (4)
Change in probing bleeding
For the evaluation of bleeding, a single trained, calibrated examiner will examine 6 sites of each tooth using a 15mm North Carolina millimeter probe (Hu-Friedy, Chicago, IL, USA) to check whether there is bleeding during the probing. The evaluation will be performed at the beginning of treatment, 30, 60 and 90 days after the treatments.
Measured: Baseline, 30, 60 and 90 days after treatment.
Change in loss of clinical insertion
A single trained, calibrated examiner will examine 6 sites in each tooth with a 15mm North Carolina millimeter probe (Hu-Friedy, Chicago, IL, USA) for the measurement of loss of clinical insertion in milimeters. The evaluation will be performed at the beginning of treatment, 30, 60 and 90 days after the treatments.
Measured: Baseline, 30, 60 and 90 days after treatment.
Change in plaque index
For the evaluation of plaque index, a single trained, calibrated examiner will examine 6 sites of each tooth with a 15mm North Carolina millimeter probe (Hu-Friedy, Chicago, IL, USA) for the measurement of the amount of plaque in milimeters. The evaluation will be performed at the beginning of treatment, 30, 60 and 90 days after treatment.
Measured: Baseline, 30, 60 and 90 days after treatment.
Microbiological examination (change in CFUs (Colony Forming Units))
The microbiological examination will be performed from subgingival biofilm samples collected from the periodontal pockets. Two collections will be performed at each experimental site before and immediately after treatments. For the collection of the subgingival biofilm, a relative isolation of the teeth with cotton rollers will be performed, the supra-gingival biofilm will be removed with sterile gauze, and the subgingival biofilm sample will be obtained by inserting a sterile absorbent paper tip (no. 30) into the inside of the pocket, being held in place for 30s. The tips will be removed and stored in properly identified sterile plastic microtubes, with each paper cone being stored in a different microtube.
The samples will be used to determine the CFUs (Colony Forming Units).
Measured: Baseline, 30, 60 and 90 days after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start15 Mar 2019 (estimated)
- Primary completion15 Nov 2019 (estimated)
- Study completion15 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renato Araujo Prates, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03855345
- Sponsor's protocol ID
- GIU
- Status last verified
- Feb 2019
- First submitted
- 22 Feb 2019
- Last updated
- 26 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antimicrobial Photodynamic Therapy Mediated by PapaMBlue® on Chronic Periodontal Disease - Randomized Blind Controlled Trial
- ClinicalTrials.gov ID
- NCT03855345
- Acronym / sponsor ID
- GIU
- Conditions
- Periodontal Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 15 Mar 2019 (estimated)
- Primary completion
- 15 Nov 2019 (estimated)
- Study completion
- 15 Apr 2020 (estimated)
- First posted
- 26 Feb 2019 (actual)
- 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.
The elimination of the pathogenic microorganisms of the periodontal pocket is one of the main points for success in periodontal treatment. The objective of this study is to investigate the clinical and antimicrobial effect of papain-mediated photodynamic therapy in the clinical treatment of periodontal disease. Twenty patients with chronic periodontitis will be selected. Patients will be divided randomly into two groups (n = 10), and the control group will receive conventional periodontal treatment and group II will receive conventional treatment and antimicrobial photodynamic therapy (aPDT). Conventional treatment will consist of oral hygiene guidance, with brushing technique instructions and recommendation of daily flossing. The calculus deposits on the teeth will be removed with ultrasound equipment and curettes for scraping and root planing. The aPDT will be performed at the end of each periodontal treatment session, at sites with bags greater than or equal to 4 mm. The PapaMblue® photosensitizer will be deposited in the periodontal pockets with a syringe and a pre-irradiation time of 1 min will be adopted. Then, the laser emitting wavelength of 660 nm, with power of 100 mW, for 2 min, radiant exposure of 30 J/cm2 and power density of 250 mW/cm2 will be applied. Patients will undergo clinical evaluations before treatment (day 1) and 30, 60 and 90 days after the end of treatment. Microbiological evaluations will be made before and 30 days after treatment. The distribution of the data within each group and the homogeneity of the variances will be verified. With this information, the most appropriate statistical test for each evaluation will be used. The sample calculation is based on the literature and the significance level of 5% will be adopted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Experimental | Procedure: Conventional treatmentIn this group, the participants will be submitted to the conventional treatment. The treatment will consist of oral hygiene orientation, with instructions of brushing technique and recommendation of the daily use of dental floss. All patients will receive a demonstration of oral hygiene techniques. The calculus deposits on the teeth will be removed with ultrasound equipment and curettes for root scaling and straightening. After the use of ultrasound and curettes, bicarbonate jet will be used to remove dental biofilm. Treatment will be performed in 2 to 4 sessions under local anesthesia (typically 2% mepivacaine with 1: 100,000 noradrenaline). Gracey periodontal curettes (numbers 3/4, 7/8, 11/12 and 13/14) and Mc Call curettes for removal of the dental calculus will be used. Other biofilm-retaining factors, such as carious lesions, condemned teeth, and ill-adapted restorations, will be removed during these periodontal treatment sessions. |
| aPDT group | Experimental | Procedure: Conventional treatment, Radiation: aPDTIn this group, besides the conventional treatments, patients will also receive aPDT. aPDT will be performed at the end of each periodontal treatment session, at sites with bags greater than or equal to 4 mm. The photosensitizer PapaMBlue® (F \& A Ltda, São Paulo, Brazil) will be deposited in the pouches with a syringe, with the application in coronal direction, and a time of 1 min of pre-irradiation will be adopted so that the substance can stain bacterial biofilm (according to the manufacturer's information). Next, the diode laser emitting wavelength of ʎ=660 nm, with power of P=100 mW, will be applied. The laser will be applied to the mucosa, over the oral epithelium with an optical fiber. Irradiation will be performed until the entire periodontal pocket is illuminated for 2 min at each point. Each irradiation point will be approximately 0.4cm2, which will result in energy density of 30 J/cm2 in 2 min irradiation. The irradiation will have a constant power density of 250 mW/cm2. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The patient must have chronic periodontitis (AAP, 2001);
- At least 10 present teeth, with at least 3 sites with clinical depth of probing greater than 4 mm;
- The patient must be in periodontal treatment at the Dental Clinic of Universidade Nove de Julho, institution where this research will be carried out;
Key exclusion criteria (10 listed)
- Smokers or former smokers who discontinued the habit less than 12 months prior to selection;
- Uncontrolled diabetes;
- Anemia;
- Cancer;
- Pregnant women;
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 |
|---|---|---|
| Conventional treatmentThe treatment will consist of oral hygiene orientation, with instructions of brushing technique and recommendation of the daily use of dental floss. All patients will receive a demonstration of oral hygiene techniques. The calculus deposits on the teeth will be removed with ultrasound equipment and curettes for root scaling and straightening. After the use of ultrasound and curettes, bicarbonate jet will be used to remove dental biofilm. Treatment will be performed in 2 to 4 sessions under local anesthesia (typically 2% mepivacaine with 1: 100,000 noradrenaline). Gracey periodontal curettes (numbers 3/4, 7/8, 11/12 and 13/14) and Mc Call curettes for removal of the dental calculus will be used. Other biofilm-retaining factors, such as carious lesions, condemned teeth, and ill-adapted restorations, will be removed during these periodontal treatment sessions. | Procedure or surgery | Control group, aPDT group |
| aPDTaPDT will be performed at the end of each periodontal treatment session, at sites with bags greater than or equal to 4 mm. The photosensitizer PapaMBlue® (F \& A Ltda, São Paulo, Brazil) will be deposited in the pouches with a syringe, with the application in coronal direction, and a time of 1 min of pre-irradiation will be adopted so that the substance can stain bacterial biofilm (according to the manufacturer's information). Next, the diode laser emitting wavelength of ʎ=660 nm, with power of P=100 mW, will be applied. The laser will be applied to the mucosa, over the oral epithelium with an optical fiber. Irradiation will be performed until the entire periodontal pocket is illuminated for 2 min at each point. Each irradiation point will be approximately 0.4cm2, which will result in energy density of 30 J/cm2 in 2 min irradiation. The irradiation will have a constant power density of 250 mW/cm2. | Radiation | aPDT group |
Primary outcome
Change in probing depth
Time frame: Baseline, 30, 60 and 90 days after treatment.
For the evaluation of probing depth, a single trained, calibrated examiner will examine 6 sites of each tooth with a 15mm North Carolina millimeter probe (Hu-Friedy, Chicago, IL, USA) for the measurement of probing depth in milimeters. The evaluation will be performed at the beginning of treatment, 30, 60 and 90 days after the tretaments.
4 secondary outcomes
Change in probing bleeding
Time frame: Baseline, 30, 60 and 90 days after treatment.
Change in loss of clinical insertion
Time frame: Baseline, 30, 60 and 90 days after treatment.
Change in plaque index
Time frame: Baseline, 30, 60 and 90 days after treatment.
Microbiological examination (change in CFUs (Colony Forming Units))
Time frame: Baseline, 30, 60 and 90 days after treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Conventional treatment and aPDT in people with Periodontal Diseases, run by University of Nove de Julho.
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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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 in probing depth (time frame: Baseline, 30, 60 and 90 days after treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Feb 2019.