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

NCT06469294 | Completed

• 2 other identifiers: 68360623.6.0000.56266.019.190
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Diabetes Mellitus, Type 2; Periodontitis, Adult; Periodontitis

Keywords

laser therapy; photodynamic therapy; chlorhexidine

Outcome Measures

Primary Outcomes (7)

• 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

• 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 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

• 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

• 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

Study Arms (2)

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.

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

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

Interventions

Control (C) - Saline Gel PROCEDURE

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.

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 blue PROCEDURE

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.

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal Fluminense: lead

Study Sites (1)

Universidade Federal Fluminense

Nova Friburgo, Rio de Janeiro, 28625650, Brazil

Location

Related Publications (1)

• 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.

  PMID: 36849595 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Chronic Periodontitis; Periodontitis

Interventions

Photochemotherapy

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Study Officials

• Gabriela AC Camargo, doctor

  University Federal Fluminense

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: the material that will be deposited, in this case, gels for the control and placebo groups will be masked by aluminum foil for research. Gels will be encoded in a syringe and applied by researcher blind to the sites and reagents, each 4 sites will receive one og the following treatments: 1 -photodynamic therapy with red laser and photosesitization with 0,005% AM gel + 2% chlorhexidine (Fórmula e Ação Farmácia, São Paulo, SP, Brazil), 2: gel saline + lasertherapy.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gabriela Alessandra da Cruz Galhardo Camargo

Model Details: Clinical, laboratory, longitudinal split-mouth study carried out in humans.

Study Record Dates

• First Submitted: June 15, 2024
• First Posted: June 21, 2024
• Study Start: May 30, 2024
• Primary Completion: October 7, 2024
• Study Completion: October 7, 2024
• Last Updated: November 26, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)