Clinical trial NCT06469294: Evaluation of Chlorhexidine Gel Associated with Photodynamic Therapy in the Treatment of Chronic Periodontitis in Type 2 Diabetics
Official title: Evaluation of Chlorhexidine Gel Associated with Photodynamic Therapy in the Treatment of Chronic Periodontitis in Type 2 Diabetics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Periodontitis, Adult
Periodontitis
Keywords: laser therapy
photodynamic therapy
chlorhexidine
Lead sponsor: Universidade Federal Fluminense
Sponsor class: OTHER
First posted: 2024-06-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Clinical, laboratory, longitudinal split-mouth study carried out in humans.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: glycemic control
timeFrame: Baseline and 3 months after
measure: Plaque index (IP)
timeFrame: Baseline and 3 months after
measure: Clinical Attachment Level (CAL)
timeFrame: Baseline and 3 months after
measure: Pocket Probing Depht (PPD)
timeFrame: baseline and 3 months after
measure: Bleending on Probing (BOP)
timeFrame: baseline and 3 months ago
measure: Clinical Recession
timeFrame: Baseline and 3 months after
measure: glycated hemoglobin
timeFrame: Baseline and 3 months after
Secondary outcomes:
Other outcomes:
Locations:
city: Nova Friburgo
country: Brazil
facility: Universidade Federal Fluminense
state: Rio de Janeiro
Study officials:
affiliation: University Federal Fluminense
name: Gabriela AC Camargo, doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.