PeriodontitisNCT06426550
Clinical and Microbiological Evaluation of Laser Therapy in the Treatment of Periodontal Disease in Stages III and IV
A study testing Antimicrobial photodynamic therapy and 0.005% methylene blue (PDT), Photobiomodulation with a red laser (PBM-RL) and Saline solution in people with Periodontitis and Periodontitis, Adult, run by Universidade Federal Fluminense at 1 site in Brazil.
Trial summary
The aim of this clinical trial is to evaluate photodynamic therapy and photobiomodulation in the periodontitis treatment. To evaluate the clinical and microbiological response of conventional periodontal treatment associated with photodynamic therapy and photobiomodulation with red or infrared laser. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Periodontitis, Adult
- What is being tested?
- Antimicrobial photodynamic therapy and 0.005% methylene blue (PDT), Photobiomodulation with a red laser (PBM-RL) and Saline solution
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 6 May 2024to 2 Feb 2026
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult participants with periodontal disease;
- Four or more periodontal sites with PPD≥6 mm and CAL≥5 mm, non-adjacent;
- Generalized periodontitis, with more than 30% of the sites involved (Caton et al., 2018);
- Stages III and IV of periodontal disease (Caton et al., 2018);
Who cannot join
- Participants with hypersensitivity to the components of the 0.005% methylene blue gel;
- Received periodontal treatment in the last six months;
- Drugs (alcoholics, use of anti-inflammatories and antibiotics in the last 3 months);
- Any evidence of systemic modifying factors which may directly interfere with the completion of the work (bias), such as:
- Pregnant and breastfeeding women;
- Hormone replacement therapy;
Show all 10Show fewer
- Smoking;
- Hyperglycemia;
- Osteoporosis;
- Diagnosed with HIV+ or AIDS.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Fluminense Federal University
Nova Friburgo, Rio de Janeiro, 28625650
About this study
The aim of this clinical trial is to evaluate photodynamic therapy and photobiomodulation in the periodontitis treatment. To evaluate the clinical and microbiological response of conventional periodontal treatment associated with photodynamic therapy and photobiomodulation with red or infrared laser.
Participants will receive periodontal treatment carried out with the use 0.005% methylene blue and laser therapy (photodynamic therapy), associated with conventional periodontal treatment, as well as the use of photobiomodulation with red or infrared laser associated with conventional periodontal treatment in participants with periodontitis. So, twenty periodontitis patients will be selected and separated in two groups compared with placebo. Clinical and microbiological parameters will be evaluated at baseline and 3 months after periodontal treatment: plaque Index, bleeding on probe, probing depth, gingival recession and clinical attachment level.
Read the detailed description
Periodontitis is a chronic, inflammatory and multifactorial disease, caused by an interaction between debiotic biofilm and its products and an exacerbated host response, leading to the progressive destruction of the supporting periodontium (bone, cement and periodontal ligament), causing loss of clinical attachment. and radiographic, bleeding on probing and periodontal pocket formation. Periodontal disease has a high prevalence and is one of the main causes of edentulism, with a great negative impact on chewing function, aesthetics and quality of life related to oral health. It is, therefore, considered a serious public health problem.
Conventional periodontal therapy consists of scaling and root planing (SRP) and control of supragingival plaque, but in some cases it has been shown to be ineffective in treating periodontitis, especially in difficult to access areas such as furcations and deep pockets. These cases benefit from adjuvant therapies, such as laser therapy, to help heal periodontal tissues, reduce microorganisms and improve clinical parameters.
Photobiomodulation and photodynamic therapy have been widely applied in the treatment of periodontal disease, due to their clinical, cellular and bactericidal effects. When associated with conventional periodontal therapy, its benefits increase, promoting a significant reduction in probing depth, number of deep pockets and bleeding. Furthermore, significant reduction of periodontopathogens and Candida albicans can be observed in the literature after photobiomodulation and photodynamic therapy.
Despite the benefits found when different laser therapy protocols are used in periodontal treatment, due to the lack of studies with high methodological quality and weak evidence in the existing literature, more studies are needed to prove their effects, establish appropriate protocols and evaluate the antimicrobial potential in periodontopathogens, which remains debatable, as recent systematic reviews point out.
The direct benefits of this study are the treatment of periodontal disease for the participants and for the scientific community to indicate new forms of periodontal therapy using different protocols of laser therapy associated with periodontal instrumentation. All tooth pocket sites in all groups will receive treatment.
- Conditions
- Periodontitis, Periodontitis, Adult
- Being tested
- Antimicrobial photodynamic therapy and 0.005% methylene blue (PDT), Photobiomodulation with a red laser (PBM-RL), Saline solution, Photobiomodulation with an infrared laser (PBM-IRL)
- Keywords
- Periodontal Diseases, Periodontal Pocket, Laser Therapy, Methylene Blue
- Medical subject headings
- Periodontitis, Chronic Periodontitis, Periodontal Diseases, Periodontal Pocket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antimicrobial photodynamic therapy and 0.005% methylene blue (PDT)Procedure or surgery
Conventional periodontal treatment, consisting of scaling and root planing, will be performed using ultrasonic instrumentation complemented by Gracey curettes, followed by antimicrobial photodynamic therapy (aPDT) with 0.005% methylene blue as the photosensitizer.
Photobiomodulation with a red laser (PBM-RL)Procedure or surgery
Conventional periodontal treatment, consisting of scaling and root planing, will be performed using ultrasonic instrumentation complemented by Gracey curettes, followed by Photobiomodulation with a red laser (PBM-RL).
Saline solutionProcedure or surgery
Conventional periodontal treatment, consisting of scaling and root planing, will be performed using ultrasonic instrumentation complemented by Gracey curettes, followed by application of saline solution as the control treatment.
Photobiomodulation with an infrared laser (PBM-IRL)Procedure or surgery
Conventional periodontal treatment, consisting of scaling and root planing, will be performed using ultrasonic instrumentation complemented by Gracey curettes, followed by photobiomodulation with an infrared laser (PBM-IRL).
| Study group | Role | What they receive |
|---|---|---|
| Antimicrobial photodynamic therapy and 0.005% methylene blue (aPDT) | Experimental | Photosensitization will be performed with 0.005% methylene blue gel for 5 minutes, and photodynamic therapy will be applied with a red laser (660 nm) using a DuoⓇ laser with the optical fiber inside the periodontal pocket in back and forth movements, for 90s, 9 joules of energy, dose of 508.5J/cm2, irradiance of 5.65W/cm2 and power of 100mW. Receives: Procedure: Antimicrobial photodynamic therapy and 0.005% methylene blue (PDT) |
| Photobiomodulation with a red laser (PBM-RL) | Experimental | Photobiomodulation will be performed with a red laser (660 nm) using a DuoⓇ laser with the optical fiber inside the periodontal pocket in back and forth movements, for 90s, 9 joules of energy, dose of 508.5J/cm2, irradiance of 5.65W/cm2 and power of 100mW. The application of the gel with an empty syringe will be simulated, and waited 5 minutes. Receives: Procedure: Photobiomodulation with a red laser (PBM-RL) |
| Photobiomodulation with an infrared laser (PBM-IRL) | Experimental | Photobiomodulation will be performed with an infrared laser (808 nm) using a DuoⓇ laser with the optical fiber inside the periodontal pocket in back and forth movements, for 90s, 9 joules of energy, dose of 508.5J/cm2, irradiance of 5.65W/cm2 and power of 100mW. The application of the gel with an empty syringe will be simulated, and waited 5 minutes. Receives: Procedure: Photobiomodulation with an infrared laser (PBM-IRL) |
| Saline solution - Control (C) | Placebo comparator | Saline gel will be applied in the periodontal pocket and, after 5 minutes, the laser application will be simulated, with the device in inactive mode. Receives: Procedure: Saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque index (PI)
Plaque index will be expressed in percentage per individual to evaluate the supragingival plaque control.
Measured: Baseline and 3 months
Bleeding on probing (BOP)
Bleeding on probing (BOP) will be expressed in percentage per individual to evaluate presence of BOP <20% good results.
Measured: Baseline and 3 months
Pocket probing depth (PPD)
Pocket probing depth (PPD) will be evaluated in millimeters. The measure will be performed at six sites per tooth using a periodontal probe. The PPD corresponds to the distance from the gingival margin to the apical portion of the gingival sulcus or periodontal pocket.
Measured: Baseline and 3 months
Gingival recession (GR)
Gingival recession (GR) will be measured clinically in millimeters with a periodontal probe as the distance from the cemento-enamel junction to the depth of the free gingival margin.
Measured: Baseline and 3 months
Clinical attachment level (CAL)
Clinical attachment level (CAL) will be measured clinically in millimeters with a periodontal probe and corresponds as the distance from the cemento-enamel junction to the base of the periodontal pocket. CAL represents the extension of periodontal support that has been lost around a tooth.
Measured: Baseline and 3 months
Secondary outcomes (1)
Microbiogical analysis
Pooled biofilms from gingival fluid of four sites with PPD with 6 mm or more will be collected to evaluate the presence of periodontal pathogens. The samples will be collected from the selected sites and stored in eppendorfs with PBS 1X in -20oC until the microbiological analyses, that will consist in DNA extraction, electroforesis and qualitative polymerase chain reaction (PCR).
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start6 May 2024
- Primary completion26 Jan 2026
- Study completion2 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Clinical, laboratory, longitudinal split-mouth study carried out in humans.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal Fluminense
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriela Alessandra da Cruz Galhardo Camargo, Universidade Federal Fluminense
- Investigators
- Gabriela AC Camargo, Doctor, Principal investigator, Fluminense Federal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06426550
- Sponsor's protocol ID
- 78007624.4.0000.5626
- Status last verified
- Feb 2026
- First submitted
- 17 May 2024
- Last updated
- 27 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The result will be communicated verbally to each participant.
Publications
Akram Z, Al-Shareef SA, Daood U, Asiri FY, Shah AH, AlQahtani MA, Vohra F, Javed F. Bactericidal Efficacy of Photodynamic Therapy Against Periodontal Pathogens in Periodontal Disease: A Systematic Review. Photomed Laser Surg. 2016 Apr;34(4):137-49. doi: 10.1089/pho.2015.4076. Epub 2016 Mar 16.
PubMed 26982216Akram Z. How effective is adjunctive antimicrobial photodynamic therapy in treating deep periodontal pockets in periodontal disease? A systematic review. J Investig Clin Dent. 2018 Nov;9(4):e12345. doi: 10.1111/jicd.12345. Epub 2018 Jun 4.
PubMed 29863310Ren C, McGrath C, Jin L, Zhang C, Yang Y. The effectiveness of low-level laser therapy as an adjunct to non-surgical periodontal treatment: a meta-analysis. J Periodontal Res. 2017 Feb;52(1):8-20. doi: 10.1111/jre.12361. Epub 2016 Mar 2.
PubMed 26932392
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Microbiological Evaluation of Laser Therapy in the Treatment of Periodontal Disease in Stages III and IV
- ClinicalTrials.gov ID
- NCT06426550
- Acronym / sponsor ID
- 78007624.4.0000.5626
- Conditions
- Periodontitis, Periodontitis, Adult
- Keywords
- Periodontal Diseases, Periodontal Pocket, Laser Therapy, Methylene Blue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universidade Federal FluminenseUniversity, hospital or other
- Study start
- 6 May 2024 (actual)
- Primary completion
- 26 Jan 2026 (actual)
- Study completion
- 2 Feb 2026 (actual)
- First posted
- 23 May 2024 (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 aim of this clinical trial is to evaluate photodynamic therapy and photobiomodulation in the periodontitis treatment. To evaluate the clinical and microbiological response of conventional periodontal treatment associated with photodynamic therapy and photobiomodulation with red or infrared laser.
Participants will receive periodontal treatment carried out with the use 0.005% methylene blue and laser therapy (photodynamic therapy), associated with conventional periodontal treatment, as well as the use of photobiomodulation with red or infrared laser associated with conventional periodontal treatment in participants with periodontitis. So, twenty periodontitis patients will be selected and separated in two groups compared with placebo. Clinical and microbiological parameters will be evaluated at baseline and 3 months after periodontal treatment: plaque Index, bleeding on probe, probing depth, gingival recession and clinical attachment level.
Detailed description
Periodontitis is a chronic, inflammatory and multifactorial disease, caused by an interaction between debiotic biofilm and its products and an exacerbated host response, leading to the progressive destruction of the supporting periodontium (bone, cement and periodontal ligament), causing loss of clinical attachment. and radiographic, bleeding on probing and periodontal pocket formation. Periodontal disease has a high prevalence and is one of the main causes of edentulism, with a great negative impact on chewing function, aesthetics and quality of life related to oral health. It is, therefore, considered a serious public health problem.
Conventional periodontal therapy consists of scaling and root planing (SRP) and control of supragingival plaque, but in some cases it has been shown to be ineffective in treating periodontitis, especially in difficult to access areas such as furcations and deep pockets. These cases benefit from adjuvant therapies, such as laser therapy, to help heal periodontal tissues, reduce microorganisms and improve clinical parameters.
Photobiomodulation and photodynamic therapy have been widely applied in the treatment of periodontal disease, due to their clinical, cellular and bactericidal effects. When associated with conventional periodontal therapy, its benefits increase, promoting a significant reduction in probing depth, number of deep pockets and bleeding. Furthermore, significant reduction of periodontopathogens and Candida albicans can be observed in the literature after photobiomodulation and photodynamic therapy.
Despite the benefits found when different laser therapy protocols are used in periodontal treatment, due to the lack of studies with high methodological quality and weak evidence in the existing literature, more studies are needed to prove their effects, establish appropriate protocols and evaluate the antimicrobial potential in periodontopathogens, which remains debatable, as recent systematic reviews point out.
The direct benefits of this study are the treatment of periodontal disease for the participants and for the scientific community to indicate new forms of periodontal therapy using different protocols of laser therapy associated with periodontal instrumentation. All tooth pocket sites in all groups will receive treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Clinical, laboratory, longitudinal split-mouth study carried out in humans.
| Arm | Type | Receives |
|---|---|---|
| Antimicrobial photodynamic therapy and 0.005% methylene blue (aPDT) | Experimental | Procedure: Antimicrobial photodynamic therapy and 0.005% methylene blue (PDT)Photosensitization will be performed with 0.005% methylene blue gel for 5 minutes, and photodynamic therapy will be applied with a red laser (660 nm) using a DuoⓇ laser with the optical fiber inside the periodontal pocket in back and forth movements, for 90s, 9 joules of energy, dose of 508.5J/cm2, irradiance of 5.65W/cm2 and power of 100mW. |
| Photobiomodulation with a red laser (PBM-RL) | Experimental | Procedure: Photobiomodulation with a red laser (PBM-RL)Photobiomodulation will be performed with a red laser (660 nm) using a DuoⓇ laser with the optical fiber inside the periodontal pocket in back and forth movements, for 90s, 9 joules of energy, dose of 508.5J/cm2, irradiance of 5.65W/cm2 and power of 100mW. The application of the gel with an empty syringe will be simulated, and waited 5 minutes. |
| Photobiomodulation with an infrared laser (PBM-IRL) | Experimental | Procedure: Photobiomodulation with an infrared laser (PBM-IRL)Photobiomodulation will be performed with an infrared laser (808 nm) using a DuoⓇ laser with the optical fiber inside the periodontal pocket in back and forth movements, for 90s, 9 joules of energy, dose of 508.5J/cm2, irradiance of 5.65W/cm2 and power of 100mW. The application of the gel with an empty syringe will be simulated, and waited 5 minutes. |
| Saline solution - Control (C) | Placebo comparator | Procedure: Saline solutionSaline gel will be applied in the periodontal pocket and, after 5 minutes, the laser application will be simulated, with the device in inactive mode. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult participants with periodontal disease;
- Four or more periodontal sites with PPD≥6 mm and CAL≥5 mm, non-adjacent;
- Generalized periodontitis, with more than 30% of the sites involved (Caton et al., 2018);
- Stages III and IV of periodontal disease (Caton et al., 2018);
Key exclusion criteria (10 listed)
- Participants with hypersensitivity to the components of the 0.005% methylene blue gel;
- Received periodontal treatment in the last six months;
- Drugs (alcoholics, use of anti-inflammatories and antibiotics in the last 3 months);
- Any evidence of systemic modifying factors which may directly interfere with the completion of the work (bias), such as:
- Pregnant and breastfeeding 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 |
|---|---|---|
| Antimicrobial photodynamic therapy and 0.005% methylene blue (PDT)Conventional periodontal treatment, consisting of scaling and root planing, will be performed using ultrasonic instrumentation complemented by Gracey curettes, followed by antimicrobial photodynamic therapy (aPDT) with 0.005% methylene blue as the photosensitizer. | Procedure or surgery | Antimicrobial photodynamic therapy and 0.005% methylene blue (aPDT) |
| Photobiomodulation with a red laser (PBM-RL)Conventional periodontal treatment, consisting of scaling and root planing, will be performed using ultrasonic instrumentation complemented by Gracey curettes, followed by Photobiomodulation with a red laser (PBM-RL). | Procedure or surgery | Photobiomodulation with a red laser (PBM-RL) |
| Saline solutionConventional periodontal treatment, consisting of scaling and root planing, will be performed using ultrasonic instrumentation complemented by Gracey curettes, followed by application of saline solution as the control treatment. | Procedure or surgery | Saline solution - Control (C) |
| Photobiomodulation with an infrared laser (PBM-IRL)Conventional periodontal treatment, consisting of scaling and root planing, will be performed using ultrasonic instrumentation complemented by Gracey curettes, followed by photobiomodulation with an infrared laser (PBM-IRL). | Procedure or surgery | Photobiomodulation with an infrared laser (PBM-IRL) |
Primary outcome
Plaque index (PI)
Time frame: Baseline and 3 months
Plaque index will be expressed in percentage per individual to evaluate the supragingival plaque control.
Bleeding on probing (BOP)
Time frame: Baseline and 3 months
Bleeding on probing (BOP) will be expressed in percentage per individual to evaluate presence of BOP <20% good results.
Pocket probing depth (PPD)
Time frame: Baseline and 3 months
Pocket probing depth (PPD) will be evaluated in millimeters. The measure will be performed at six sites per tooth using a periodontal probe. The PPD corresponds to the distance from the gingival margin to the apical portion of the gingival sulcus or periodontal pocket.
Gingival recession (GR)
Time frame: Baseline and 3 months
Gingival recession (GR) will be measured clinically in millimeters with a periodontal probe as the distance from the cemento-enamel junction to the depth of the free gingival margin.
Clinical attachment level (CAL)
Time frame: Baseline and 3 months
Clinical attachment level (CAL) will be measured clinically in millimeters with a periodontal probe and corresponds as the distance from the cemento-enamel junction to the base of the periodontal pocket. CAL represents the extension of periodontal support that has been lost around a tooth.
1 secondary outcome
Microbiogical analysis
Time frame: Baseline and 3 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 27 Feb 2026.
- Background: PubMed 26982216Akram Z, Al-Shareef SA, Daood U, Asiri FY, Shah AH, AlQahtani MA, Vohra F, Javed F. Bactericidal Efficacy of Photodynamic Therapy Against Periodontal Pathogens in Periodontal Disease: A Systematic Review. Photomed Laser Surg. 2016 Apr;34(4):137-49. doi: 10.1089/pho.2015.4076. Epub 2016 Mar 16.
- Background: PubMed 29863310Akram Z. How effective is adjunctive antimicrobial photodynamic therapy in treating deep periodontal pockets in periodontal disease? A systematic review. J Investig Clin Dent. 2018 Nov;9(4):e12345. doi: 10.1111/jicd.12345. Epub 2018 Jun 4.
- Background: PubMed 26932392Ren C, McGrath C, Jin L, Zhang C, Yang Y. The effectiveness of low-level laser therapy as an adjunct to non-surgical periodontal treatment: a meta-analysis. J Periodontal Res. 2017 Feb;52(1):8-20. doi: 10.1111/jre.12361. Epub 2016 Mar 2.
- Individual participant dataSharing planned: No. The result will be communicated verbally to each participant.
Related trials for Periodontitis
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
Probiotics, Antibiotics
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel
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.
Gabriela AC Camargo, Doctor principal investigator
Fluminense Federal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antimicrobial photodynamic therapy and 0.005% methylene blue (PDT), Photobiomodulation with a red laser (PBM-RL) and Saline solution in people with Periodontitis and Periodontitis, Adult, run by Universidade Federal Fluminense at 1 site in Brazil.
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 4 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: finished, as of the sponsor's last update on 27 Feb 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 Brazil. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Plaque index (PI) (time frame: Baseline and 3 months). The study lists 5 primary outcomes in all. 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 NCT06426550, which also lists 3 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 27 Feb 2026.