치주 치료 후 클로르헥시딘과 오디나무 구강 세정제의 효과
클로르헥시딘과 오디나무(모루스 니그라) 구강청결제의 치주 질환 치료 효과 비교
This study aims to evaluate and compare the clinical, biochemical, and microbiological effects of chlorhexidine and Morus nigra mouthwashes used as an adjunct to non-surgical periodontal treatment (scaling and root planing - SRP) in patients with periodontal diseases. The participants will be divided into three groups: a control group receiving only SRP, a group receiving SRP combined with chlorhexidine mouthwash, and a group receiving SRP combined with Morus nigra mouthwash. Clinical periodontal parameters, gingival crevicular fluid levels of inflammatory markers (including TNF-a, IL-1b, and IL-10), and subgingival plaque microbiological profiles (such as red complex bacteria and Fusobacterium) will be evaluated at baseline, 1 month, and 3 months after the treatment.
연구 개요
상태
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Malatya
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Battalgazi, Malatya, 터키 (Türkiye), 44300
- Inonu University Faculty of Dentistry
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients diagnosed with periodontitis.
- Systemically healthy individuals.
- Patients aged between 18 and 65 years.
- Presence of at least 20 natural teeth.
- Volunteering to participate in the study and signing the informed consent form.
Exclusion Criteria:
- Presence of any systemic disease that may affect periodontal health or systemic inflammatory response (e.g., Diabetes Mellitus, immunological disorders).
- Current smokers or use of any tobacco products.
- Pregnancy or lactation.
- Use of systemic antibiotics, anti-inflammatory drugs, or immunosuppressive medications within the last 6 months.
- Having received any non-surgical or surgical periodontal treatment within the last 6 months.
- Known allergy or sensitivity to chlorhexidine or Morus nigra (blackberry) extracts.
- Patients using orthodontic appliances.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Control Group
Non-surgical periodontal treatment consisting of full-mouth scaling and root planing (SRP) using ultrasonic and hand instruments. |
All patients in the study underwent non-surgical periodontal therapy consisting of full-mouth scaling and root planing (SRP) using both ultrasonic devices and hand instruments. |
|
실험적: Chlorhexidine Group
As an adjunct to scaling and root planing, patients will rinse with 15 ml of 0.12% chlorhexidine gluconate mouthwash twice a day (morning and evening) for 1 minute. The duration of the intervention is 14 days. |
All patients in the study underwent non-surgical periodontal therapy consisting of full-mouth scaling and root planing (SRP) using both ultrasonic devices and hand instruments. As an adjunct to SRP, patients were instructed to rinse with 15 ml of 0.12% chlorhexidine gluconate mouthwash twice daily (morning and evening) for 1 minute. The treatment duration was 14 days. |
|
실험적: Morus Nigra Group
As an adjunct to scaling and root planing, patients will rinse with 15 ml of a standardized mouthwash containing 5% Morus nigra extract twice a day (morning and evening) for 1 minute. The duration of the intervention is 14 days. |
All patients in the study underwent non-surgical periodontal therapy consisting of full-mouth scaling and root planing (SRP) using both ultrasonic devices and hand instruments. As an adjunct to SRP, patients were instructed to rinse with 15 ml of a standardized mouthwash containing 5% Morus nigra extract twice daily (morning and evening) for 1 minute. The treatment duration was 14 days. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Gingival Index (GI)
기간: Baseline (Day 0), 1 month, and 3 months after periodontal treatment.
|
Evaluation of gingival inflammation using a scale of 0 to 3. |
Baseline (Day 0), 1 month, and 3 months after periodontal treatment.
|
|
Plaque Index (PI)
기간: Baseline (Day 0), 1 month, and 3 months after periodontal treatment.
|
Evaluation of plaque accumulation using a scale of 0 to 3. |
Baseline (Day 0), 1 month, and 3 months after periodontal treatment.
|
|
Probing Depth (PD)
기간: Baseline (Day 0), 1 month, and 3 months after periodontal treatment.
|
Measurement of the distance from the gingival margin to the bottom of the periodontal pocket. |
Baseline (Day 0), 1 month, and 3 months after periodontal treatment.
|
|
Clinical Attachment Level (CAL)
기간: Baseline (Day 0), 1 month, and 3 months after periodontal treatment.
|
Measurement of the distance from the cementoenamel junction to the bottom of the periodontal pocket. |
Baseline (Day 0), 1 month, and 3 months after periodontal treatment.
|
|
Bleeding on Probing (BOP)
기간: Baseline (Day 0), 1 month, and 3 months after periodontal treatment.
|
Evaluation of the presence or absence of bleeding within 30 seconds after probing. The result is recorded as a percentage of sites that bleed. |
Baseline (Day 0), 1 month, and 3 months after periodontal treatment.
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Gingival Crevicular Fluid (GCF) Inflammatory Markers
기간: At baseline, 1 month, and 3 months after treatment
|
Analysis of TNF-a, IL-1b, and IL-10 levels in the gingival crevicular fluid using ELISA (or specific biochemical assay) to evaluate the local inflammatory response |
At baseline, 1 month, and 3 months after treatment
|
|
Change in Subgingival Plaque Microbiological Profile
기간: At baseline, 1 month, and 3 months after treatment
|
Evaluation of subgingival plaque samples to determine the levels of red complex bacteria and Fusobacterium nucleatum using PCR (Polymerase Chain Reaction) analysis |
At baseline, 1 month, and 3 months after treatment
|
공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
- INONU-2025/04
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
De-identified individual participant data that underlie the results reported in the published article will be shared
IPD 공유 기간
Data will be available beginning 6 months and ending 36 months following article publication.
IPD 공유 액세스 기준
Data will be shared with researchers who provide a methodologically sound proposal. Requests for data sharing should be directed to the principal investigator via email
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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