Effects of Using Miswak in Addition to Oral Hygiene Products in Patients With Gingivitis

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorMustafa Kemal University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Miswak

    Combination product

    Participants used miswak (Salvadora persica L.) as an adjunct to toothbrushing, five times per day, for one month before periodontal treatment.

  • Toothpaste

    Other intervention

    Participants used a manual toothbrush twice daily for one month before periodontal treatment.

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: Test Group: Miswak using2 interventions
Group B: control group1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
Pre-op 4 weeks and after 6 weeks

Secondary outcomes

1

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.

Time frame
Pre-op 4 weeks and after 6 weeks
2

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.

Time frame
Pre-op 4 weeks and after 6 weeks
3

Change in Salivary Oxidative Stress Levels

To evaluate changes in salivary oxidative stress levels following adjunctive miswak use using appropriate biochemical assays.

Time frame
Pre-op 4 weeks and after 6 weeks

Other outcomes

Sponsors and contacts

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