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

NCT07689786 | Not Yet Recruiting

• 1 other identifier: 11/2025
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Gingivitis; Chronic

Keywords

periodontal disease; gingivitis; periodontal inflamation; miswak

Outcome Measures

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).

  Pre-op 4 weeks and after 6 weeks

Secondary Outcomes (3)

• Change in Clinical Periodontal Indices

  Pre-op 4 weeks and after 6 weeks

• Change in Salivary C-Reactive Protein (CRP) Levels

  Pre-op 4 weeks and after 6 weeks

• Change in Salivary Oxidative Stress Levels

  Pre-op 4 weeks and after 6 weeks

Study Arms (2)

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

Miswak COMBINATION_PRODUCT

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

Test Group: Miswak using

Toothpaste OTHER

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

Test Group: Miswak using; control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• Smoking
• History of recent periodontal treatment

Sponsors & Collaborators

• Mustafa Kemal University: lead

Study Sites (2)

Hatay Mustafa Kemal University

Antakya, Hatay, 31000, Turkey (Türkiye)

Location

Hatay Mustafa Kemal Üniversitesi

Hatay, 31000, Turkey (Türkiye)

Location

Related Publications (7)

• 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.

  PMID: 40853679 BACKGROUND

• 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.

  PMID: 34415433 BACKGROUND

• 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.

  PMID: 25177663 BACKGROUND

• 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.

  PMID: 35944735 BACKGROUND

• 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.

  PMID: 25935172 BACKGROUND

• 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.

  PMID: 30890435 BACKGROUND

• 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.

  PMID: 34776994 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Unstimulated Saliva

MeSH Terms

Conditions

Gingivitis; Bronchiolitis Obliterans Syndrome; Periodontal Diseases

Interventions

Toothpastes

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dentifrices; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Hasan Burak Sen, DDs

  Hatay Mustafa Kemal Üniversitesi

  PRINCIPAL INVESTIGATOR

• Ayşegül Sari, PhD

  Hatay Mustafa Kemal Üniversitesi

  STUDY DIRECTOR

Central Study Contacts

Aysegul Sari, PhD

CONTACT

05321732518; aysglsr@gmail.com

Hasan Burak SEN, res. assist.

CONTACT

Türkiye; buraksenh1999@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 8, 2026
• Study Start: July 4, 2026
• Primary Completion (Estimated): July 4, 2027
• Study Completion (Estimated): July 4, 2027
• Last Updated: July 8, 2026

Record last verified: 2026-07

Locations

TU (2)