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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
| |
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Miswak | Combination Product | Participants used miswak (Salvadora persica L.) as an adjunct to toothbrushing, five times per day, for one month before periodontal treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pre-op 4 weeks and after 6 weeks |
| Change in Salivary C-Reactive Protein (CRP) Levels |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aysegul Sari, PhD | Contact | 05321732518 | aysglsr@gmail.com | |
| Hasan Burak SEN, res. assist. | Contact | Türkiye | 506 222 86 33 | buraksenh1999@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hasan Burak Sen, DDs | Hatay Mustafa Kemal Üniversitesi | Principal Investigator |
| Ayşegül Sari, PhD | Hatay Mustafa Kemal Üniversitesi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hatay Mustafa Kemal University | Antakya | Hatay | 31000 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40853679 | Background | 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. | |
| 34415433 | 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. |
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| ID | Term |
|---|---|
| D005891 | Gingivitis |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| D010510 | Periodontal Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D014100 | Toothpastes |
| ID | Term |
|---|---|
| D003802 | Dentifrices |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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Unstimulated Saliva
| Toothpaste | Other | Participants used a manual toothbrush twice daily for one month before periodontal treatment. |
|
To evaluate changes in salivary C-reactive protein (CRP) concentrations as a marker of oral inflammatory status following adjunctive miswak use. |
| Pre-op 4 weeks and after 6 weeks |
| Change in Salivary Oxidative Stress Levels | To evaluate changes in salivary oxidative stress levels following adjunctive miswak use using appropriate biochemical assays. | Pre-op 4 weeks and after 6 weeks |
| Hatay Mustafa Kemal Üniversitesi | Hatay | 31000 | Turkey (Türkiye) |
|
| 25177663 | 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. |
| 35944735 | 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. |
| 25935172 | 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. |
| 30890435 | 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. |
| 34776994 | 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. |
| D000092124 |
| Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |