About this trial
This pilot study aims to evaluate the effects of miswak use on the oral biological environment by comparing biochemical parameters obtained from saliva and dental plaque samples collected from individuals who use miswak and controls. A total of 36 healthy volunteers will be enrolled in the study, including 18 miswak+rutine oral hygiene products users and 18 rutine oral hygiene products.
Periodontal clinical parameters will be recorded, and saliva and supragingival dental plaque samples will be collected from all participants. The collected samples will be analysed for biomarkers associated with periodontal inflammation and oxidative stress. Interleukin-1 beta (IL-1β), C-reactive protein (CRP), and oxidative stress levels will be measured using biochemical analysis.
The findings of this study are expected to provide preliminary evidence regarding the biological effects of miswak on oral health and contribute to the current understanding of its potential role as an adjunctive oral hygiene tool.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
To be in the age range of 18-60 years
To have no systemic disease
To be diagnosed with gingivitis
Disqualifiers
Smoking
History of recent periodontal treatment
Trial population
Patients diagnosed with gingivitis who attended the Department of Periodontology and met the eligibility criteria. Eligible participants will be systemic healthy patients with gingivitis who have not received periodontal treatment for 6 months. A total of 36 participants were enrolled and randomly allocated to the intervention and control groups.
Trial design
Cohort
Prospective
Treatments tested in this trial
Miswak
Combination productParticipants used miswak (Salvadora persica L.) as an adjunct to toothbrushing, five times per day, for one month before periodontal treatment.
Toothpaste
Other interventionParticipants used a manual toothbrush twice daily for one month before periodontal treatment.
Treatment groups
Trial outcomes
Primary outcomes
Change in Salivary Interleukin-1 Beta (IL-1β) Levels
To evaluate the effect of adjunctive miswak use on salivary interleukin-1 beta (IL-1β) levels in patients with gingivitis. Salivary IL-1β concentrations will be measured using enzyme-linked immunosorbent assay (ELISA).
Secondary outcomes
Change in Clinical Periodontal Indices
To evaluate changes in clinical periodontal parameters, including Plaque Index (PI), Gingival Index (GI), and Bleeding on Probing (BOP) following adjunctive miswak use.
Change in Salivary C-Reactive Protein (CRP) Levels
To evaluate changes in salivary C-reactive protein (CRP) concentrations as a marker of oral inflammatory status following adjunctive miswak use.
Change in Salivary Oxidative Stress Levels
To evaluate changes in salivary oxidative stress levels following adjunctive miswak use using appropriate biochemical assays.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: