Gingivitis; ChronicNCT07689786
Effects of Using Miswak in Addition to Oral Hygiene Products in Patients With Gingivitis
An observational study of Gingivitis; Chronic, run by Mustafa Kemal University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis; Chronic
- What is being tested?
- Miswak and Toothpaste
- Type of treatment
- Pill or oral medicine
- How many people
- 36 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 4 Jul 2026to 4 Jul 2027
- How long will I take part?
- 10 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- To be in the age range of 18-60 years
- To have no systemic disease
- To be diagnosed with gingivitis
Who cannot join
- Smoking
- History of recent periodontal treatment
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites
Hatay Mustafa Kemal University
Antakya, Hatay, 31000
Aysegul Sari, PhD, 05321732518, aysglsr@gmail.com
Hasan Burak Sen, DDs, 05062228633, buraksenh1999@gmail.com
Hatay Mustafa Kemal Üniversitesi
Hatay, 31000
Ayşegül Sari, PhD, 05321732518, aysglsr@gmail.com
Hasan Burak Sen, DDs, 05062228633, buraksenh1999@gmail.com
About this study
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
- Being tested
- Miswak, Toothpaste
- Keywords
- periodontal disease, gingivitis, periodontal inflamation, miswak
- Medical subject headings
- Gingivitis, Bronchiolitis Obliterans Syndrome, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiswakCombination product
Participants used miswak (Salvadora persica L.) as an adjunct to toothbrushing, five times per day, for one month before periodontal treatment.
ToothpasteOther
Participants used a manual toothbrush twice daily for one month before periodontal treatment.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Other: Toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Pre-op 4 weeks and after 6 weeks
Secondary outcomes (3)
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.
Measured: Pre-op 4 weeks and after 6 weeks
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.
Measured: 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.
Measured: Pre-op 4 weeks and after 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start4 Jul 2026 (estimated)
- Primary completion4 Jul 2027 (estimated)
- Study completion4 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Gingivitis; ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
- Target duration
- 10 Weeks
Sponsor and investigators
- Lead sponsor
- Mustafa Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysegul SARI, Mustafa Kemal University
- Investigators
- Hasan Burak Sen, DDs, Principal investigator, Hatay Mustafa Kemal ÜniversitesiAyşegül Sari, PhD, Study director, Hatay Mustafa Kemal Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07689786
- Sponsor's protocol ID
- 11/2025
- Status last verified
- Jul 2026
- First submitted
- 1 Jul 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 40853679Sari 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 34415433Bansal 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 25177663Ramli 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 35944735Haque 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 25935172Lebda 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 30890435Martinez-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
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Using Miswak in Addition to Oral Hygiene Products in Patients With Gingivitis
- ClinicalTrials.gov ID
- NCT07689786
- Acronym / sponsor ID
- 11/2025
- Conditions
- Gingivitis; Chronic
- Keywords
- periodontal disease, gingivitis, periodontal inflamation, miswak
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Mustafa Kemal UniversityUniversity, hospital or other
- Study start
- 4 Jul 2026 (estimated)
- Primary completion
- 4 Jul 2027 (estimated)
- Study completion
- 4 Jul 2027 (estimated)
- First posted
- 8 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group: Miswak using | – | Combination Product: Miswak, Other: ToothpasteParticipants 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 | – | Other: Toothpastearticipants 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). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- To be in the age range of 18-60 years
- To have no systemic disease
- To be diagnosed with gingivitis
Key exclusion criteria (2 listed)
- Smoking
- History of recent periodontal treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MiswakParticipants used miswak (Salvadora persica L.) as an adjunct to toothbrushing, five times per day, for one month before periodontal treatment. | Combination product | Test Group: Miswak using |
| ToothpasteParticipants used a manual toothbrush twice daily for one month before periodontal treatment. | Other | Test Group: Miswak using, control group |
Primary outcome
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).
3 secondary outcomes
Change in Clinical Periodontal Indices
Time frame: Pre-op 4 weeks and after 6 weeks
Change in Salivary C-Reactive Protein (CRP) Levels
Time frame: Pre-op 4 weeks and after 6 weeks
Change in Salivary Oxidative Stress Levels
Time frame: Pre-op 4 weeks and after 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Background: PubMed 40853679Sari 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.
- Background: PubMed 34415433Sari 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.
- Background: PubMed 25177663Bansal 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.
- Background: PubMed 35944735Ramli 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.
- Background: PubMed 25935172Haque 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.
- Background: PubMed 30890435Lebda 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.
- Background: PubMed 34776994Martinez-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hasan Burak Sen, DDs principal investigator
Hatay Mustafa Kemal Üniversitesi
Ayşegül Sari, PhD study director
Hatay Mustafa Kemal Üniversitesi
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gingivitis; Chronic, run by Mustafa Kemal University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aysegul Sari, PhD (05321732518, aysglsr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Salivary Interleukin-1 Beta (IL-1β) Levels (time frame: Pre-op 4 weeks and after 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07689786, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.