- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Ayşegül Sari, PhD
- 전화번호: 05321732518
- 이메일: aysglsr@gmail.com
연구 연락처 백업
- 이름: Hasan Burak SEN, res. assist.
- 전화번호: 506 222 86 33 Türkiye
- 이메일: buraksenh1999@gmail.com
연구 장소
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Hatay, 터키 (Türkiye), 31000
- Hatay Mustafa Kemal Üniversitesi
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연락하다:
- Ayşegül Sari, PhD
- 전화번호: 05321732518
- 이메일: aysglsr@gmail.com
-
연락하다:
- Hasan Burak Sen, DDs
- 전화번호: 05062228633
- 이메일: buraksenh1999@gmail.com
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Hatay
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Antakya, Hatay, 터키 (Türkiye), 31000
- Hatay Mustafa Kemal University
-
연락하다:
- Ayşegül Sari, PhD
- 전화번호: 05321732518
- 이메일: aysglsr@gmail.com
-
연락하다:
- Hasan Burak Sen, DDs
- 전화번호: 05062228633
- 이메일: buraksenh1999@gmail.com
-
수석 연구원:
- Hasan Burak Sen, DDs
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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).
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Participants used miswak (Salvadora persica L.) as an adjunct to toothbrushing, five times per day, for one month before periodontal treatment.
Participants used a manual toothbrush twice daily for one month before periodontal treatment.
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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).
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Participants used a manual toothbrush twice daily for one month before periodontal treatment.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Salivary Interleukin-1 Beta (IL-1β) Levels
기간: Pre-op 4 weeks and after 6 weeks
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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).
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Pre-op 4 weeks and after 6 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Clinical Periodontal Indices
기간: Pre-op 4 weeks and after 6 weeks
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To evaluate changes in clinical periodontal parameters, including Plaque Index (PI), Gingival Index (GI), and Bleeding on Probing (BOP) following adjunctive miswak use.
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Pre-op 4 weeks and after 6 weeks
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Change in Salivary C-Reactive Protein (CRP) Levels
기간: Pre-op 4 weeks and after 6 weeks
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To evaluate changes in salivary C-reactive protein (CRP) concentrations as a marker of oral inflammatory status following adjunctive miswak use.
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Pre-op 4 weeks and after 6 weeks
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Change in Salivary Oxidative Stress Levels
기간: Pre-op 4 weeks and after 6 weeks
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To evaluate changes in salivary oxidative stress levels following adjunctive miswak use using appropriate biochemical assays.
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Pre-op 4 weeks and after 6 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Hasan Burak Sen, DDs, Hatay Mustafa Kemal Üniversitesi
- 연구 책임자: Ayşegül Sari, PhD, Hatay Mustafa Kemal Üniversitesi
간행물 및 유용한 링크
일반 간행물
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 11/2025
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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