Subgingival Lactobacillus Reuteri as an Adjunct to Non-Surgical Periodontal Therapy in Diabetic Patients (LREUTERI-DM)
Effect of Adjunctive Subgingival Lactobacillus Reuteri in Non-Surgical Periodontal Therapy for Periodontitis in Patients With Diabetes: A Randomized Controlled Clinical Trial
연구 개요
상태
상세 설명
Periodontitis is a chronic inflammatory disease associated with dysbiotic subgingival biofilms and is strongly influenced by diabetes mellitus. Chronic hyperglycemia may impair immune function and wound healing, resulting in increased periodontal destruction and poorer treatment outcomes. Non-surgical periodontal therapy based on scaling and root planing (SRP) remains the standard treatment; however, residual periodontal pockets may persist after therapy.
Lactobacillus reuteri probiotics have demonstrated antimicrobial, anti-inflammatory, and host-modulatory properties and may enhance periodontal healing. This randomized controlled clinical trial evaluated the adjunctive effects of subgingival administration of a liquid probiotic preparation containing Lactobacillus reuteri in diabetic patients with Stage III Grade B or higher periodontitis.
Forty periodontal sites were randomly allocated to either a test group receiving SRP plus subgingival Lactobacillus reuteri probiotics or a control group receiving SRP plus saline irrigation. A second application was performed at the 1-month visit. Clinical outcomes included plaque index, gingival index, bleeding on probing, probing pocket depth, and clinical attachment level. Glycemic control was evaluated using HbA1c levels, and microbiological analysis was performed using real-time PCR for Porphyromonas gingivalis, Tannerella forsythia, and Fusobacterium nucleatum.
Assessments were conducted at baseline, 1 month, and 3 months. The primary objective was to evaluate changes in clinical outcomes. Secondary objectives included microbiological and glycemic outcomes.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Ho Chi Minh City
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Ho Chi Minh City, Ho Chi Minh City, 베트남, 700000
- Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Age ≥18 years.
- Diagnosed with diabetes mellitus according to WHO criteria.
- Stage III Grade B periodontitis or higher according to the 2017 AAP/EFP classification.
- At least 15 remaining teeth.
- Periodontal pockets ≥5 mm with bleeding on probing.
- Clinical attachment loss ≥5 mm.
Exclusion Criteria:
- Current smokers.
- Pregnant or lactating women.
- Use of antibiotics or anti-inflammatory medications within 1 month before enrollment.
- Periodontal therapy within the previous 3 months.
- Undergoing orthodontic treatment.
- Presence of pulpal lesions or severe occlusal trauma.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: SRP + Lactobacillus reuteri
Subgingival Lactobacillus reuteri
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Subgingival administration of liquid Lactobacillus reuteri following scaling and root planing.
The probiotic solution was applied into periodontal pockets at baseline and re-applied after 1 month.
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활성 비교기: SRP + Saline
Saline Control
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Subgingival administration of sterile saline solution following scaling and root planing.
Saline was applied into periodontal pockets at baseline and re-applied after 1 month using the same protocol as the test intervention.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Bleeding on Probing (BOP)
기간: Baseline to 3 months
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Bleeding on probing was assessed at baseline, 1 month, and 3 months after treatment.
Changes in the percentage of bleeding sites were used to evaluate periodontal inflammation.
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Baseline to 3 months
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Change in Probing Pocket Depth (PPD)
기간: Baseline to 3 months.
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Probing pocket depth was measured using a UNC-15 periodontal probe at baseline, 1 month, and 3 months after treatment.
The primary outcome was the change in PPD from baseline to 3 months.
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Baseline to 3 months.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Clinical Attachment Level (CAL)
기간: Baseline to 3 months.
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Clinical attachment level (CAL) was measured using a UNC-15 periodontal probe.
Changes in CAL was assessed to evaluate periodontal attachment gain following treatment.
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Baseline to 3 months.
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Changes in Glycated Hemoglobin (HbA1c)
기간: Baseline, 1 month, and 3 months
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HbA1c levels were assessed at baseline, 1 month, and 3 months following treatment to evaluate glycemic control.
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Baseline, 1 month, and 3 months
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Changes in Subgingival Periodontal Pathogens
기간: Baseline to 3 months
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Quantitative levels of Porphyromonas gingivalis, Tannerella forsythia, Fusobacterium nucleatum were assessed using microbiological analysis.
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Baseline to 3 months
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공동 작업자 및 조사자
수사관
- 연구 의자: Thu Nguyen Ngoc Yen, PhD, Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City
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
기타 연구 ID 번호
- THS-PERIO-2026-01
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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