Periodontal Diseases Clinical Trial
Official title:
Clinical and Biochemical Evaluation Oral Irrigator Effectiveness in Patients Under Orthodontic Treatment
Verified date | September 2022 |
Source | Ondokuz Mayis University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The present study aimed to investigate clinically the cleaning effectiveness of different treatment modalities, that is, oral irrigator or interdental brush usage addition to routine brushing and examine interleukin (IL)-1β, IL-10, matrix metalloproteinase (MMP)-1, MMP-8 levels in gingival crevicular fluid of orthodontic patients. The null hypothesis was that oral irrigators would be effective compared to interdental brush in the oral care of individuals who are orthodontic patients.
Status | Completed |
Enrollment | 30 |
Est. completion date | December 27, 2018 |
Est. primary completion date | August 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years and older |
Eligibility | Inclusion Criteria: - Being over 12 years old. - Having at least 20 permanent teeth with bands or brackets. - Finished phase I periodontal treatment. - Bleeding below 10% during probing. - No pocket depth of more than 5 mm. - Not receiving any treatment other than orthodontic treatment during the study. - Absence of removable or fixed prosthetic restorations. - Absence of any systemic disease (hepatic, renal, hematologic, cardiovascular). - Agreeing not to use any non-study mouthwash throughout the study. Exclusion Criteria: - Performing poor cooperation. - Having diseases associated with bacteriemia. - Used antibiotics and anti-inflammatory drugs for any purpose for a long time. - Having diabetes. - Smoking habits. - Having a physical or mental problem that affects manual dexterity. - Using medication that could affect gingival health (such as dilantin, calcium channel blocker, cyclosporine, and anticoagulant). |
Country | Name | City | State |
---|---|---|---|
Turkey | Ondokuz Mayis University, Faculty of Dentistry, Department of Periodontology | Samsun |
Lead Sponsor | Collaborator |
---|---|
Ondokuz Mayis University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | GCF (gingival crevicular fluid) level of IL-1ß as a marker of gingival inflammation | Elevated levels of IL-1ß in GCF have been associated with the destructive changes that occur in the inflamed human gingiva, is a proinflammatory cytokine. | through study completion, an average of 1 year | |
Primary | GCF (gingival crevicular fluid) level of IL-10 as a marker of gingival inflammation | IL-10 plays an important role as a stop signal in suppressing the immune and inflammatory response by being released from periodontal tissues, thus trying to limit the spread and severity of the disease. It is an anti-inflammatory cytokine. It is reported that the level of GCF IL-10 is increased in inflamed areas. | through study completion, an average of 1 year | |
Primary | GCF (gingival crevicular fluid) level of MMP-1 as a marker of gingival inflammation | One of the MMPs, MMP-1, is generally expressed by fibroblasts, endothelial cells, keratinocytes, monocytes/macrophages, chondrocytes, and osteoblasts, and is a key regulator in connective tissue remodeling. In addition to gingivitis, there is a significant increase in MMP-1 levels in the GCF during the active periods of periodontitis. | through study completion, an average of 1 year | |
Primary | GCF (gingival crevicular fluid) level of MMP-8 as a marker of gingival inflammation | High concentration of MMP-8 is associated with tissue destruction and severity of periodontal disease. It is known to be secreted from inflammatory cells such as neutrophils and macrophages. | through study completion, an average of 1 year |
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