Evaluation of Chlorhexidine Gel Associated With Photodynamic Therapy in the Treatment in Diabetic Participants
NCT Number: NCT06469294
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetes Mellitus, Type 2|Periodontitis, Adult|Periodontitis
Interventions: PROCEDURE: Periodontal treatment|PROCEDURE: Periodontal procedure|PROCEDURE: Oral treatment
Sponsor: Universidade Federal Fluminense
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-15
Completion Date: 2028-11
Locations: Universidade Federal Fluminense, Nova Friburgo, Rio De Janeiro, 28625650, Brazil

Summary:
The objective of this clinical trial is to evaluate chlorhexidine gel associated with photodynamic therapy in the treatment of chronic periodontitis in diabetic participants.

The main questions it aims to answer are:

• To evaluate the clinical and microbiological response of conventional periodontal treatment associated with photodynamic therapy in diabetic participants.

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 with conventional periodontal treatment in diabetic participants with periodontitis. So, twenty periodontitis patients will be selected and will separated in two groups compared with placebo. And, Clinical 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.

Primary Outcome Measures: 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., 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 \< 3 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., 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), 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., Baseline and 3 months after