Ignite Creation Date:
2024-07-17 @ 10:45 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06469294
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-06-15
Brief Title:
Evaluation of Chlorhexidine Gel Associated With Photodynamic Therapy in the Treatment in Diabetic Participants
Sponsor:
Universidade Federal Fluminense
Organization:
Universidade Federal Fluminense
Study Overview
Official Title:
Evaluation of Chlorhexidine Gel Associated With Photodynamic Therapy in the Treatment of Chronic Periodontitis in Diabetic Participants
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 0005 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
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 0005 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
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 hosts 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
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 hosts 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 6019190 | REGISTRY | None | None |