Evaluation of Chlorhexidine Gel Associated With Photodynamic Therapy in the Treatment in Diabetic Participants

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Evaluation of Chlorhexidine Gel Associated With Photodynamic Therapy in the Treatment of Chronic Periodontitis in Diabetic Participants

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06469294
• Other study ID #: 68360623.6.0000.5626
• Secondary ID: 6.019.190
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2024
• Est. completion date: November 2028

Study information

• Verified date: June 2024
• Source: Universidade Federal Fluminense
• Contact: Gabriela AC Camargo, doctor
• Phone: 12981815874
• Email: gabrielacruz[@]id.uff.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: November 2028
• Est. primary completion date: November 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Periodontitis
• Diabetes Mellitus, Type 2
• Periodontitis
• Periodontitis, Adult

Intervention

Procedure:
• Periodontal treatment
An experienced periodontist will be performed clinical periodontal parameters, including Plaque Index, Bleeding On Probe, Pocket Probing Depth, Gingival Recession, Clinical Attachment Level using a periodontal probe, at six sites per tooth at all teeth, excluding third molars. Quadrant scaling and root planning will be weekly performed on each patient under local anestesia using periodontal curettes and ultrasonic scalers. The maintenance therapy will be included professional plaque control and scaling and root planing in recurrent periodontal pockets, will be performed with ultrasound (Dabi Atlante, Rio de Janeiro, RJ, Brazil) complemented with Gracey curettes (Golgran, São Caetano do Sul, SP, Brazil) on each patient under local anesthesia. The maintenance therapy will be include every 30 days, until 3 months, when the periodontal parameters will be reassessed.
• Periodontal procedure
An experienced periodontist will be performed clinical periodontal parameters, including Plaque Index, Bleeding On Probe, Pocket Probing Depth, Gingival Recession, Clinical Attachment Level using a periodontal probe, at six sites per tooth at all teeth, excluding third molars. Quadrant scaling and root planning will be weekly performed on each patient under local anestesia using periodontal curettes and ultrasonic scalers. The maintenance therapy will be included professional plaque control and scaling and root planing in recurrent periodontal pockets, will be performed with ultrasound (Dabi Atlante, Rio de Janeiro, RJ, Brazil) complemented with Gracey curettes (Golgran, São Caetano do Sul, SP, Brazil) on each patient under local anesthesia. The maintenance therapy will be include every 30 days, until 3 months, when the periodontal parameters will be reassessed.
• Oral treatment
An experienced periodontist will be performed clinical periodontal parameters, including Plaque Index, Bleeding On Probe, Pocket Probing Depth, Gingival Recession, Clinical Attachment Level using a periodontal probe, at six sites per tooth at all teeth, excluding third molars. Quadrant scaling and root planning will be weekly performed on each patient under local anestesia using periodontal curettes and ultrasonic scalers. The maintenance therapy will be included professional plaque control and scaling and root planing in recurrent periodontal pockets, will be performed with ultrasound (Dabi Atlante, Rio de Janeiro, RJ, Brazil) complemented with Gracey curettes (Golgran, São Caetano do Sul, SP, Brazil) on each patient under local anesthesia. The maintenance therapy will be include every 30 days, until 3 months, when the periodontal parameters will be reassessed.

Locations

Country	Name	City	State
Brazil	Universidade Federal Fluminense	Nova Friburgo	Rio De Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal Fluminense

Country where clinical trial is conducted

Brazil, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Plaque index (IP)	Plaque index are used to evaluate the level and rate of plaque formation on tooth surfaces	Baseline and 3 months after
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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