Diabetes Mellitus, Type 2NCT06469294
Evaluation of Chlorhexidine Gel Associated with Photodynamic Therapy in the Treatment of Chronic Periodontitis in Type 2 Diabetics
A study testing Test (t) - Photodynamic therapy and 2% chlorexidine and 0,005% methylene blue in people with Diabetes Mellitus, Type 2 and Periodontitis, Adult, run by Universidade Federal Fluminense at 1 site in Brazil.
Trial summary
The objective of this clinical trial is to evaluate chlorhexidine gel associated with photodynamic therapy in the treatment of chronic periodontitis in Type 2 diabetics The main questions it aims to answer are: To evaluate if the use of 2% chlorhexidine gel associated with 0.005% methylene blue and laser therapy is… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Periodontitis, Adult, Periodontitis
- What is being tested?
- Test (t) - Photodynamic therapy and 2% chlorexidine and 0,005% methylene blue
- Type of treatment
- 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
- 30 May 2024to 7 Oct 2024
- 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
- Participants over 18 years old
- Adults with type 2 diabetics
- Adults with periodontal disease
- Pockets with probing depth greater than 5 mm.
Who cannot join
- Participants with hypersensitivity to the components of chlorhexidine gel or methylene blue and laser therapy
- Drugs ( alcoholics, anti-inflammatories and antibiotics in the last 6 months)
- Any evidence of systemic modifying factors of periodontal disease, except diabetics, and which, therefore, may directly interfere with the completion of the work. The factors described in the literature include:
- osteoporosis types I and II
- acquired or induced immunosuppression
- Pregnant or lactating women
Show all 9Show fewer
- clinical manifestations of oral candidosis
- anti-inflammatories or hormone replacement therapy
- physical/emotional stress, medications that influence periodontal tissues.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal Fluminense
Nova Friburgo, Rio de Janeiro, 28625650
About this study
The objective of this clinical trial is to evaluate chlorhexidine gel associated with photodynamic therapy in the treatment of chronic periodontitis in Type 2 diabetics
The main questions it aims to answer are:
Read more
- To evaluate if the use of 2% chlorhexidine gel associated with 0.005% methylene blue and laser therapy is superior to conventional periodontal treatment associated with photodynamic therapy in Type 2 diabetics
Participants will receive periodontal treatment carried out with the use of 2% chlorhexidine gel associated with 0.005% methylene blue and laser therapy, associated with conventional periodontal treatment, as well as the use of photodynamic therapy associated to conventional periodontal treatment in Type 2 diabetics patientes. So, 20 periodontitis patients will be selected. Patients will be separated in two groups; Test, use of 2% chlorhexidine gel associated with 0.005% methylene blue and laser therapy + Periodontal Disease with PD> 5mm and Control, conventional periodontal treatment with gel control with fisiological solution + Laser therapy. Clinical parameters and microbiological parameters were evaluated at baseline and 3 months after periodontal treatment: Plaque Index, Bleeding On Probe, Probing depth, Gingival Recession and Clinical Attachment Level, and Microbiological parameters will be checked by PCR, for evaluating A.a, P.g., T.f., C.albicans.
Read the detailed description
Periodontal disease is a polymicrobial inflammatory condition caused by infection of periodontal tissues resulting from the accumulation of bacterial biofilm, which can result in the progressive loss of the conjunctival attachment and alveolar bone. The destructive nature of diseases and their progression depend on the composition of the supra and subgingival biofilm. In response to the imbalance between host and microorganisms, the host can respond to biofilm products by generating periodontal infection. This process can result in the production of enzymes and other endogenous mediators of the inflammatory response, being responsible for much of the tissue destruction observed through clinical and histopathological parameters.
Non-surgical periodontal therapy, performed using the conventional method, tooth scaling and root planing, represents a prerequisite for the control of periodontal infections and, in most cases, is sufficient to restore periodontal health. However, some factors may be present and associated with the failure of mechanical therapy, which may be related to failure to eliminate pathogens, due to difficulty in accessing the scalers to the base of the periodontal pocket, root anatomical variations, or systemic factors that modify the response. of the host.
An important risk factor for periodontal disease is diabetes. It affects oral health and may be one of the causes for the increase in cases of tooth loss. The risk of diabetic participants having periodontitis is approximately three times greater than that of healthy participants. Diabetes can trigger an increase in the inflammatory response to the oral microbiota and can impair the host's immune response, thereby creating advanced conditions for the development and worsening of periodontal diseases in predisposed participants. At the same time, periodontitis is responsible for increasing insulin resistance and can increase the risk of diabetes or promote an impairment of glucose tolerance mechanisms. Given the bidirectional transparency between diabetes and periodontitis, it has been demonstrated that non-surgical periodontal treatment (NSPT) in participants with periodontitis and diabetes can influence glycemic control.
For the treatment of periodontal disease, surgical or non-surgical periodontal therapy is used as a basis, which aims to reduce the infection caused by dental plaque. But laser therapy is currently used as an adjuvant treatment in cases of periodontitis. The use of low-power lasers and photosensitizers has improved the reduction of bone loss and elimination of pathogenic bacteria, in addition to decontaminating periodontal pockets with almost no damage.
The direct benefits of the study are the treatment and resolution of periodontal disease for the participant and for the scientific community to indicate new forms of periodontal therapy using these medications associated with periodontal instrumentation. All tooth pocket sites in all groups will receive treatment.
- Being tested
- Control (C) - Saline Gel, Test (t) - Photodynamic therapy and 2% chlorexidine and 0,005% methylene blue
- Keywords
- laser therapy, photodynamic therapy, chlorhexidine
- Medical subject headings
- Diabetes Mellitus, Type 2, Chronic Periodontitis, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control (C) - Saline GelProcedure or surgery
After conventional periodontal treatment, 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, in order to maintain blinding of the patients.
Test (t) - Photodynamic therapy and 2% chlorexidine and 0,005% methylene blueProcedure or surgery
After conventional periodontal treatment, photosensitization will be performed with 2% chlorhexidine gel with 0.005% methylene blue (Fórmula e Ação Farmácia, São Paulo, SP, Brasil) for 5 minutes and photodynamic therapy will be applied with a rede laser (660nm) usinf DuoⓇ laser (MMOptics, São Carlos, SP, Brazil) with the optical fiber inside the periodontal pocket in back and forth movements, according to the manufacturer's protocol, for 90s, 9 joules of energy, dose of 508.5J/cm2, irradiance of 5.65W/cm2 and power of 100mW.
| Study group | Role | What they receive |
|---|---|---|
| Test (T) - Photodynamic therapy and 2% chlorexidine and 0,005% methylene blue | Experimental | After conventional periodontal treatment, photosensitization will be performed with 2% chlorhexidine gel with 0.005% methylene blue (Fórmula e Ação Farmácia, São Paulo, SP, Brasil) for 5 minutes and photodynamic therapy will be applied with a rede laser (660nm) usinf DuoⓇ laser (MMOptics, São Carlos, SP, Brazil) with the optical fiber inside the periodontal pocket in back and forth movements, according to the manufacturer's protocol, for 90s, 9 joules of energy, dose of 508.5J/cm2, irradiance of 5.65W/cm2 and power of 100mW. Receives: Procedure: Control (C) - Saline Gel; Procedure: Test (t) - Photodynamic therapy and 2% chlorexidine and 0,005% methylene blue |
| Control (C) - Saline Gel | Placebo comparator | After conventional periodontal treatment, 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, in order to maintain blinding of the patients. Application of the gel for 5 minutes and photodynamic therapy will be applied with a rede laser (660nm) usinf DuoⓇ laser (MMOptics, São Carlos, SP, Brazil) with the optical fiber inside the periodontal pocket in back and forth movements, according to the manufacturer's protocol, for 90s, 9 joules of energy, dose of 508.5J/cm2, irradiance of 5.65W/cm2 and power of 100mW Receives: Procedure: Control (C) - Saline Gel; Procedure: Test (t) - Photodynamic therapy and 2% chlorexidine and 0,005% methylene blue |
What is being measured
The primary outcome is the main question the study is designed to answer.
glycemic control
Glycemic control is the optimal serum glucose concentration in diabetic patients. It is necessary to identify factors affecting the glycemic control of patients to prevent control and complications.
The American Diabetes Association (ADA) recommends that a HbA1c level of less than 7.0% indicates glycemic control for most adults with diabetes.
Measured: Baseline and 3 months after
Plaque index (IP)
Plaque index are used to evaluate the level and rate of plaque formation on tooth surfaces
Measured: Baseline and 3 months after
Clinical Attachment Level (CAL)
CAL represents the extent of periodontal support that has been lost around a tooth and is measured with the periodontal probe as the distance from the cemento-enamel junction (CEJ) to the base of the pockesites per tooth, from cementoenamel junction to gingival margin, using periodontal probe < 3mm indicate good results.
Measured: Baseline and 3 months after
Pocket Probing Depht (PPD)
Probing depth (referred to as pocket depth if periodontal disease is present) is the distance from the gingival margin to the apical portion of the gingival sulcussites 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. Less than or equal to 3 millimeters
Measured: baseline and 3 months after
Bleending on Probing (BOP)
Bleeding on probing (BOP) is the primary parameter to set the threshold for gingivitis and is recorded using the gingival index score (GI). Less than 10% of bleeding sites.
Measured: baseline and 3 months ago
Clinical Recession
Gingival recession is the exposure of the root surface resulting from migration of the gingival margin apical to the cementoenamel junction (CEJ).
Measured: Baseline and 3 months after
glycated hemoglobin
Glycated hemoglobin, also known as HbA1c, glycohemoglobin, glycosylated hemoglobin, or simply A1c. HbA1c is measured primarily to determine the three-month average blood sugar level and can be used as a diagnostic test for diabetes mellitus and as an assessment of glycemic control. The American Diabetes Association (ADA) recommends an HbA1c level of less than 7.0% as a glycemic target for nonpregnant adults with diabetes.
Measured: Baseline and 3 months after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start30 May 2024
- Primary completion7 Oct 2024
- Study completion7 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Double blind
- Who is masked
- Participant, Investigator
- 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, University Federal Fluminense
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06469294
- Sponsor's protocol ID
- 68360623.6.0000.5626
- Other IDs
- 6.019.190
- Status last verified
- May 2024
- First submitted
- 15 Jun 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The result will be communicated verbally to each participant.
Publications
Corbella S, Calciolari E, Donos N, Alberti A, Ercal P, Francetti L. Laser treatments as an adjunct to non-surgical periodontal therapy in subjects with periodontitis and type 2 diabetes mellitus: a systematic review and meta-analysis. Clin Oral Investig. 2023 Apr;27(4):1311-1327. doi: 10.1007/s00784-023-04873-y. Epub 2023 Feb 28.
PubMed 36849595
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Chlorhexidine Gel Associated with Photodynamic Therapy in the Treatment of Chronic Periodontitis in Type 2 Diabetics
- ClinicalTrials.gov ID
- NCT06469294
- Acronym / sponsor ID
- 68360623.6.0000.5626
- Keywords
- laser therapy, photodynamic therapy, chlorhexidine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universidade Federal FluminenseUniversity, hospital or other
- Study start
- 30 May 2024 (actual)
- Primary completion
- 7 Oct 2024 (actual)
- Study completion
- 7 Oct 2024 (actual)
- First posted
- 21 Jun 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 objective of this clinical trial is to evaluate chlorhexidine gel associated with photodynamic therapy in the treatment of chronic periodontitis in Type 2 diabetics
The main questions it aims to answer are:
- To evaluate if the use of 2% chlorhexidine gel associated with 0.005% methylene blue and laser therapy is superior to conventional periodontal treatment associated with photodynamic therapy in Type 2 diabetics
Participants will receive periodontal treatment carried out with the use of 2% chlorhexidine gel associated with 0.005% methylene blue and laser therapy, associated with conventional periodontal treatment, as well as the use of photodynamic therapy associated to conventional periodontal treatment in Type 2 diabetics patientes. So, 20 periodontitis patients will be selected. Patients will be separated in two groups; Test, use of 2% chlorhexidine gel associated with 0.005% methylene blue and laser therapy + Periodontal Disease with PD> 5mm and Control, conventional periodontal treatment with gel control with fisiological solution + Laser therapy. Clinical parameters and microbiological parameters were evaluated at baseline and 3 months after periodontal treatment: Plaque Index, Bleeding On Probe, Probing depth, Gingival Recession and Clinical Attachment Level, and Microbiological parameters will be checked by PCR, for evaluating A.a, P.g., T.f., C.albicans.
Detailed description
Periodontal disease is a polymicrobial inflammatory condition caused by infection of periodontal tissues resulting from the accumulation of bacterial biofilm, which can result in the progressive loss of the conjunctival attachment and alveolar bone. The destructive nature of diseases and their progression depend on the composition of the supra and subgingival biofilm. In response to the imbalance between host and microorganisms, the host can respond to biofilm products by generating periodontal infection. This process can result in the production of enzymes and other endogenous mediators of the inflammatory response, being responsible for much of the tissue destruction observed through clinical and histopathological parameters.
Non-surgical periodontal therapy, performed using the conventional method, tooth scaling and root planing, represents a prerequisite for the control of periodontal infections and, in most cases, is sufficient to restore periodontal health. However, some factors may be present and associated with the failure of mechanical therapy, which may be related to failure to eliminate pathogens, due to difficulty in accessing the scalers to the base of the periodontal pocket, root anatomical variations, or systemic factors that modify the response. of the host.
An important risk factor for periodontal disease is diabetes. It affects oral health and may be one of the causes for the increase in cases of tooth loss. The risk of diabetic participants having periodontitis is approximately three times greater than that of healthy participants. Diabetes can trigger an increase in the inflammatory response to the oral microbiota and can impair the host's immune response, thereby creating advanced conditions for the development and worsening of periodontal diseases in predisposed participants. At the same time, periodontitis is responsible for increasing insulin resistance and can increase the risk of diabetes or promote an impairment of glucose tolerance mechanisms. Given the bidirectional transparency between diabetes and periodontitis, it has been demonstrated that non-surgical periodontal treatment (NSPT) in participants with periodontitis and diabetes can influence glycemic control.
For the treatment of periodontal disease, surgical or non-surgical periodontal therapy is used as a basis, which aims to reduce the infection caused by dental plaque. But laser therapy is currently used as an adjuvant treatment in cases of periodontitis. The use of low-power lasers and photosensitizers has improved the reduction of bone loss and elimination of pathogenic bacteria, in addition to decontaminating periodontal pockets with almost no damage.
The direct benefits of the study are the treatment and resolution of periodontal disease for the participant and for the scientific community to indicate new forms of periodontal therapy using these medications 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
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Clinical, laboratory, longitudinal split-mouth study carried out in humans.
| Arm | Type | Receives |
|---|---|---|
| Test (T) - Photodynamic therapy and 2% chlorexidine and 0,005% methylene blue | Experimental | Procedure: Control (C) - Saline Gel, Procedure: Test (t) - Photodynamic therapy and 2% chlorexidine and 0,005% methylene blueAfter conventional periodontal treatment, photosensitization will be performed with 2% chlorhexidine gel with 0.005% methylene blue (Fórmula e Ação Farmácia, São Paulo, SP, Brasil) for 5 minutes and photodynamic therapy will be applied with a rede laser (660nm) usinf DuoⓇ laser (MMOptics, São Carlos, SP, Brazil) with the optical fiber inside the periodontal pocket in back and forth movements, according to the manufacturer's protocol, for 90s, 9 joules of energy, dose of 508.5J/cm2, irradiance of 5.65W/cm2 and power of 100mW. |
| Control (C) - Saline Gel | Placebo comparator | Procedure: Control (C) - Saline Gel, Procedure: Test (t) - Photodynamic therapy and 2% chlorexidine and 0,005% methylene blueAfter conventional periodontal treatment, 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, in order to maintain blinding of the patients. Application of the gel for 5 minutes and photodynamic therapy will be applied with a rede laser (660nm) usinf DuoⓇ laser (MMOptics, São Carlos, SP, Brazil) with the optical fiber inside the periodontal pocket in back and forth movements, according to the manufacturer's protocol, for 90s, 9 joules of energy, dose of 508.5J/cm2, irradiance of 5.65W/cm2 and power of 100mW |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants over 18 years old
- Adults with type 2 diabetics
- Adults with periodontal disease
- Pockets with probing depth greater than 5 mm.
Key exclusion criteria (9 listed)
- Participants with hypersensitivity to the components of chlorhexidine gel or methylene blue and laser therapy
- Drugs ( alcoholics, anti-inflammatories and antibiotics in the last 6 months)
- Any evidence of systemic modifying factors of periodontal disease, except diabetics, and which, therefore, may directly interfere with the completion of the work. The factors described in the literature include:
- osteoporosis types I and II
- acquired or induced immunosuppression
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 |
|---|---|---|
| Control (C) - Saline GelAfter conventional periodontal treatment, 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, in order to maintain blinding of the patients. | Procedure or surgery | Control (C) - Saline Gel, Test (T) - Photodynamic therapy and 2% chlorexidine and 0,005% methylene blue |
| Test (t) - Photodynamic therapy and 2% chlorexidine and 0,005% methylene blueAfter conventional periodontal treatment, photosensitization will be performed with 2% chlorhexidine gel with 0.005% methylene blue (Fórmula e Ação Farmácia, São Paulo, SP, Brasil) for 5 minutes and photodynamic therapy will be applied with a rede laser (660nm) usinf DuoⓇ laser (MMOptics, São Carlos, SP, Brazil) with the optical fiber inside the periodontal pocket in back and forth movements, according to the manufacturer's protocol, for 90s, 9 joules of energy, dose of 508.5J/cm2, irradiance of 5.65W/cm2 and power of 100mW. | Procedure or surgery | Control (C) - Saline Gel, Test (T) - Photodynamic therapy and 2% chlorexidine and 0,005% methylene blue |
Primary outcome
glycemic control
Time frame: Baseline and 3 months after
Glycemic control is the optimal serum glucose concentration in diabetic patients. It is necessary to identify factors affecting the glycemic control of patients to prevent control and complications. The American Diabetes Association (ADA) recommends that a HbA1c level of less than 7.0% indicates glycemic control for most adults with diabetes.
Plaque index (IP)
Time frame: Baseline and 3 months after
Plaque index are used to evaluate the level and rate of plaque formation on tooth surfaces
Clinical Attachment Level (CAL)
Time frame: Baseline and 3 months after
CAL represents the extent of periodontal support that has been lost around a tooth and is measured with the periodontal probe as the distance from the cemento-enamel junction (CEJ) to the base of the pockesites per tooth, from cementoenamel junction to gingival margin, using periodontal probe < 3mm indicate good results.
Pocket Probing Depht (PPD)
Time frame: baseline and 3 months after
Probing depth (referred to as pocket depth if periodontal disease is present) is the distance from the gingival margin to the apical portion of the gingival sulcussites 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. Less than or equal to 3 millimeters
Bleending on Probing (BOP)
Time frame: baseline and 3 months ago
Bleeding on probing (BOP) is the primary parameter to set the threshold for gingivitis and is recorded using the gingival index score (GI). Less than 10% of bleeding sites.
Clinical Recession
Time frame: Baseline and 3 months after
Gingival recession is the exposure of the root surface resulting from migration of the gingival margin apical to the cementoenamel junction (CEJ).
glycated hemoglobin
Time frame: Baseline and 3 months after
Glycated hemoglobin, also known as HbA1c, glycohemoglobin, glycosylated hemoglobin, or simply A1c. HbA1c is measured primarily to determine the three-month average blood sugar level and can be used as a diagnostic test for diabetes mellitus and as an assessment of glycemic control. The American Diabetes Association (ADA) recommends an HbA1c level of less than 7.0% as a glycemic target for nonpregnant adults with diabetes.
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 26 Nov 2024.
- Background: PubMed 36849595Corbella S, Calciolari E, Donos N, Alberti A, Ercal P, Francetti L. Laser treatments as an adjunct to non-surgical periodontal therapy in subjects with periodontitis and type 2 diabetes mellitus: a systematic review and meta-analysis. Clin Oral Investig. 2023 Apr;27(4):1311-1327. doi: 10.1007/s00784-023-04873-y. Epub 2023 Feb 28.
- Individual participant dataSharing planned: No. The result will be communicated verbally to each participant.
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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.
Gabriela AC Camargo, doctor principal investigator
University Federal Fluminense
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test (t) - Photodynamic therapy and 2% chlorexidine and 0,005% methylene blue in people with Diabetes Mellitus, Type 2 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 9 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 26 Nov 2024. 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?
glycemic control (time frame: Baseline and 3 months after). The study lists 7 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 NCT06469294, which also lists 1 linked publication.
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 Nov 2024.