Evaluation of Chlorhexidine Gel Associated with Photodynamic Therapy in the Treatment of Chronic Periodontitis in Type 2 Diabetics

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Periodontitis; Periodontitis, Adult
• Intervention / Treatment: Procedure: Control (C) - Saline Gel; Procedure: Test (t) - Photodynamic therapy and 2% chlorexidine and 0,005% methylene blue

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio de Janeiro
    • Nova Friburgo, Rio de Janeiro, Brazil, 28625650
      • Universidade Federal Fluminense

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Participants over 18 years old
• Adults with type 2 diabetics
• Adults with periodontal disease
• Pockets with probing depth greater than 5 mm.

Exclusion Criteria:

• 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
• clinical manifestations of oral candidosis
• anti-inflammatories or hormone replacement therapy
• physical/emotional stress, medications that influence periodontal tissues.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test (T) - Photodynamic therapy and 2% chlorexidine and 0,005% methylene blue; 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.	Procedure: Control (C) - Saline Gel; 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.; Procedure: Test (t) - Photodynamic therapy and 2% chlorexidine and 0,005% methylene blue; 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.
Placebo Comparator: Control (C) - Saline Gel; 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	Procedure: Control (C) - Saline Gel; 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.; Procedure: Test (t) - Photodynamic therapy and 2% chlorexidine and 0,005% methylene blue; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plaque index (IP)	Plaque index are used to evaluate the level and rate of plaque formation on tooth surfaces	Baseline and 3 months after
Clinical Recession	Gingival recession is the exposure of the root surface resulting from migration of the gingival margin apical to the cementoenamel junction (CEJ).	Baseline and 3 months after
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.	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.	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	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.	baseline and 3 months ago
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.	Baseline and 3 months after

Collaborators and Investigators

• Sponsor: Universidade Federal Fluminense
• Investigators: Principal Investigator: Gabriela AC Camargo, doctor, University Federal Fluminense

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2024
• Primary Completion (Actual): October 7, 2024
• Study Completion (Actual): October 7, 2024

Study Registration Dates

• First Submitted: June 15, 2024
• First Submitted That Met QC Criteria: June 15, 2024
• First Posted (Actual): June 21, 2024

Study Record Updates

• Last Update Posted (Estimated): November 26, 2024
• Last Update Submitted That Met QC Criteria: November 23, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: laser therapy; chlorhexidine; photodynamic therapy
• Additional Relevant MeSH Terms: Endocrine System Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Chronic Disease; Disease Attributes; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Periodontitis; Diabetes Mellitus, Type 2; Chronic Periodontitis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Methylene Blue
• Other Study ID Numbers: 68360623.6.0000.5626; 6.019.190 (Registry Identifier: Gabriela Alessandra da Cruz Galhardo Camargo)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The result will be communicated verbally to each participant.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No