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Not yet recruitingNCT07689786Updated Jul 8, 2026

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

An observational study in Gingivitis; Chronic, sponsored by Mustafa Kemal University. Not yet recruiting at 2 sites in Turkey (Türkiye). Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-08.

Sponsored by Mustafa Kemal University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
36
Ages
18 Years to 60 Years
Sex
All
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Study summary

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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Conditions studied

  • Gingivitis; Chronic

Keywords

  • periodontal disease
  • gingivitis
  • periodontal inflamation
  • miswak
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In context

Gingivitis

631 studies on the registry are indexed under Gingivitis; 107 are open to participants now.

This study's planned enrollment of 36 is below the median of 93 across 116 observational studies indexed under Gingivitis.

Browse Gingivitis studies →

Lead sponsor

Mustafa Kemal University is the lead sponsor of 77 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study 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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Smoking
  • History of recent periodontal treatment
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
36 participants (estimated)
Target follow-up
10 Weeks
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • Test Group: Miswak using

    Participants received oral hygiene instructions and used a manual toothbrush twice daily in combination with miswak (Salvadora persica L.) five times daily for one month before periodontal treatment. Clinical periodontal parameters will be recorded, and salivary IL-1β, CRP, and oxidative stress levels will be evaluated at pre-op (4 weeks), baseline (before periodontal treatment), and post-op (6 weeks).

    Combination Product: Miswak · Other: Toothpaste

  • control group

    articipants with gingivitis received oral hygiene instructions and used a manual toothbrush twice daily without miswak. Clinical periodontal parameters will be recorded, and salivary IL-1β, CRP, and oxidative stress levels will be evaluated at pre-op (4 weeks), baseline (before periodontal treatment), and post-op (6 weeks).

    Other: Toothpaste

Interventions

  • Combination productMiswak

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

  • OtherToothpaste

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

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What researchers measure

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

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Study locations

2 sites
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References and documents

Publications

  • Sari A, Santamaria P, Nibali L. The effect of non-surgical periodontal treatment on progranulin levels. J Periodontol. 2026 Apr;97(4):658-670. doi: 10.1002/jper.11396. Epub 2025 Aug 25. PubMed 40853679 ↗
  • Sari A, Davutoglu V, Bozkurt E, Taner IL, Erciyas K. Effect of periodontal disease on oxidative stress markers in patients with atherosclerosis. Clin Oral Investig. 2022 Feb;26(2):1713-1724. doi: 10.1007/s00784-021-04144-8. Epub 2021 Aug 20. PubMed 34415433 ↗
  • Bansal T, Pandey A, D D, Asthana AK. C-Reactive Protein (CRP) and its Association with Periodontal Disease: A Brief Review. J Clin Diagn Res. 2014 Jul;8(7):ZE21-4. doi: 10.7860/JCDR/2014/8355.4646. Epub 2014 Jul 20. PubMed 25177663 ↗
  • Ramli H, Nor Aripin KN, Mohd Said S, Mohamad Hanafiah R, Mohd Dom TN. The effectiveness of miswak (Salvadora persica L. and Azadirachta indica A.Juss.) practices in reducing plaque and gingivitis among adults: A systematic review and meta-analysis. J Ethnopharmacol. 2022 Nov 15;298:115598. doi: 10.1016/j.jep.2022.115598. Epub 2022 Aug 6. PubMed 35944735 ↗
  • Haque MM, Alsareii SA. A review of the therapeutic effects of using miswak (Salvadora Persica) on oral health. Saudi Med J. 2015 May;36(5):530-43. doi: 10.15537/smj.2015.5.10785. PubMed 25935172 ↗
  • Lebda MA, El-Hawarry WN, Shourbela RM, El-Far AH, Shewita RS, Mousa SA. Miswak (Salvadora persica) dietary supplementation improves antioxidant status and nonspecific immunity in Nile tilapia (Oreochromis niloticus). Fish Shellfish Immunol. 2019 May;88:619-626. doi: 10.1016/j.fsi.2019.03.037. Epub 2019 Mar 16. PubMed 30890435 ↗
  • Martinez-Garcia M, Hernandez-Lemus E. Periodontal Inflammation and Systemic Diseases: An Overview. Front Physiol. 2021 Oct 27;12:709438. doi: 10.3389/fphys.2021.709438. eCollection 2021. PubMed 34776994 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07689786
Lead sponsor
Mustafa Kemal University
Responsible party
Aysegul SARI (Assoc Prof, Mustafa Kemal University) — Principal investigator
First posted
Jul 8, 2026
Start date
Jul 4, 2026 (estimated)
Primary completion
Jul 4, 2027 (estimated)
Completion
Jul 4, 2027 (estimated)
Last update
Jul 8, 2026

Study contacts

Aysegul Sari, PhD
Contact
aysglsr@gmail.com
05321732518
Hasan Burak SEN, res. assist.
Contact
buraksenh1999@gmail.com
Türkiye ext. 506 222 86 33
Hasan Burak Sen, DDs
principal investigator · Hatay Mustafa Kemal Üniversitesi
Ayşegül Sari, PhD
study director · Hatay Mustafa Kemal Üniversitesi

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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