Effect of water flosser use compared with interdental brush on salivary IL-4 and IL-6 on plaque-induced gingivitis.
Trial Snapshot
- Phase
- Unknown
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 52
- Locations
- 1
Study Overview
Brief Summary
This study titled "Effect of water flosser use compared with interdental brush on salivary IL-4 and IL-6 on plaque-induced gingivitis" aims to evaluate and compare effect of water flosser use in management of dental plaque and gingival inflammation as compared to interdental brush.Water flossers are oral irrigation devices that deliver pulsating streams of water to disrupt and flush out dental plaque and debris from interproximal and subgingival areas. In this study participants will be instructed to use a cordless water flosser (ORACURA Smart Water Flosser, Model OC150) once daily for interdental cleaning for a period of 4 weeks. The device will be standardized at a moderate pulsating pressure of approximately 60 PSI with a pulsation frequency of 1200–1800 pulses per minute. Several clinical studies have reported improvements in gingival inflammation and plaque control with the use of water flossers. However, most of the available evidence is based primarily on clinical indices, and there is limited research evaluating the biological or inflammatory response associated with their use. Salivary biomarkers provide a non-invasive method to assess inflammatory changes in periodontal tissues. Interleukin-6 (IL-6) is a pro-inflammatory cytokine involved in the progression of gingival inflammation, while Interleukin-4 (IL-4) is an anti-inflammatory cytokine associated with immune modulation. Changes in the salivary levels of these biomarkers can reflect the inflammatory status of gingival tissues and the response to oral hygiene interventions.
This single-blind randomized controlled clinical trial will be conducted among patients with plaque-induced gingivitis attending the outpatient department of Periodontology at AB Shetty Memorial Institute of Dental Sciences. A total of 52 participants will be randomly allocated into two groups: water flosser group and interdental brush group. Clinical parameters including Plaque Index, Gingival Index, and Bleeding on Probing will be assessed at baseline and 4 weeks. Salivary samples will be collected and analysed for IL-4 and IL-6 levels using ELISA. The study aims to evaluate and compare the clinical and inflammatory effects of water flosser and interdental brush in the management of plaque-induced gingivitis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 40.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Adults between 18-40 years of age with plaque induced gingivitis.
- •Patients with periodontal pocket depth less than 3mm and no clinical attachment loss.
- •Patients willing for participation and have provided written consent.
Exclusion Criteria
- •Patients suffering from systemic diseases, which may have an impact on the periodontium, such as diabetes mellitus and osteoporosis.
- •Unco-operative patients
- •Patients on antibiotics and/or anti-inflammatory drugs.
- •Patients with periodontal disease, as characterized by purulent exudates, generalized mobility, and/or severe recession
- •Pregnant and lactating mothers
- •Smokers and smokeless tobacco users.
- •Patient with orthodontic appliance or prosthetic appliance.
Investigators
Dr Nikita Nagaraj Hoskeri
A B Shetty Memorial institute of Dental Sciences