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

Universidade Federal Fluminense

Status: Completed

Conditions: Periodontitis; Diabetes Mellitus, Type 2; Periodontitis, Adult

Treatments: Procedure: Control (C) - Saline Gel; Procedure: Test (t) - Photodynamic therapy and 2% chlorexidine and 0,005% methylene blue

Study type: Interventional

Funder types: Other

Identifiers

NCT06469294

6.019.190 (Registry Identifier)

68360623.6.0000.5626

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

Test (T) - Photodynamic therapy and 2% chlorexidine and 0,005% methylene blue

Experimental group

Description:

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.

Treatment:

Procedure: Test (t) - Photodynamic therapy and 2% chlorexidine and 0,005% methylene blue

Procedure: Control (C) - Saline Gel

Control (C) - Saline Gel

Placebo Comparator group

Description:

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

Treatment:

Procedure: Test (t) - Photodynamic therapy and 2% chlorexidine and 0,005% methylene blue

Procedure: Control (C) - Saline Gel