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NCT Number: NCT07689786

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

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.

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Key information

Conditions

Gingivitis; Chronic Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Gingival Diseases Gingivitis Graft vs Host Disease Immune System Diseases Infections Lung Diseases Lung Diseases, Obstructive Mouth Diseases Organizing Pneumonia Periodontal Diseases Respiratory Tract Diseases Stomatognathic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hatay Mustafa Kemal University, Antakya, Hatay, Turkey (Türkiye)

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • To be in the age range of 18-60 years
  • To have no systemic disease
  • To be diagnosed with gingivitis

Exclusion criteria

  • Smoking
  • History of recent periodontal treatment

Treatment and study plan

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

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

Primary outcomes

  1. Change in Salivary Interleukin-1 Beta (IL-1β) Levels

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

    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

  1. Change in Clinical Periodontal Indices

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

    To evaluate changes in clinical periodontal parameters, including Plaque Index (PI), Gingival Index (GI), and Bleeding on Probing (BOP) following adjunctive miswak use.

  2. Change in Salivary C-Reactive Protein (CRP) Levels

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

    To evaluate changes in salivary C-reactive protein (CRP) concentrations as a marker of oral inflammatory status following adjunctive miswak use.

  3. Change in Salivary Oxidative Stress Levels

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Aysegul Sari, PhD

CONTACT

[email protected]

05321732518

Hasan Burak SEN, res. assist.

CONTACT

[email protected]

Türkiye ext. 506 222 86 33

Sponsors and collaborators

Lead sponsor

Mustafa Kemal University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 8, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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