Clinical, Microbiological and Immunological Effects of the Adjuvant Use of Systemic Antibiotics and Probiotics in the Non-surgical Treatment of Periodontitis
Clinical, Microbiological and Immunological Effects of the Adjuvant Use of Systemic Antibiotics and Probiotics in the Non-surgical Treatment of Periodontitis: a Controlled and Randomized Clinical Trial
연구 개요
상세 설명
Scaling and root planing (SRP) is the most widely used treatment modality in periodontal therapy. However, a subset of periodontal sites does not respond adequately to this approach, and certain individuals exhibit susceptibility patterns that limit their response to initial treatment. Therefore, to overcome the limitations of SRP alone, adjunctive therapies-such as antibiotics and probiotics-may be employed.
The aim of this randomized, controlled, double-blind clinical trial is to evaluate the effects of adjunctive therapies (antibiotics and probiotics) associated with non-surgical periodontal therapy in individuals diagnosed with periodontitis stages III or IV, grades B or C. A total of sixty individuals with a clinical diagnosis of periodontitis will be treated with SRP alone or SRP combined with antibiotics or probiotics. Participants will be randomly allocated into three groups: Control (SRP), Test 1 (SRP + amoxicillin and metronidazole), and Test 2 (SRP + probiotics).
The adjunctive agents evaluated in this study will be a combination of systemic antibiotics (amoxicillin and metronidazole) and the probiotic Bifidobacterium animalis subsp. lactis HN019. Antibiotics will be administered for 14 days, three times daily, whereas probiotics will be administered for 90 days, twice daily. Adjunctive therapies will commence immediately after the first week of periodontal instrumentation.
Clinical follow-up will be conducted at baseline (pre-intervention), and at 3, 6, 9, and 12 months post-treatment. At baseline, 6 months, and 12 months, gingival crevicular fluid, subgingival biofilm, peripheral blood, and fecal samples will be collected, along with the assessment of periodontal clinical parameters. Levels of the cytokines IL-6, TNF-α, IFN-γ, IL-10, IL-1β, and IL-8 will be quantified in gingival crevicular fluid and peripheral blood samples using enzyme-linked immunosorbent assays.
Subgingival biofilm and fecal samples will be subjected to 16S ribosomal RNA gene amplification by PCR and sequenced using Illumina technology (MiSeq or MiniSeq; Illumina, San Diego, CA, USA). Sequencing data will be analyzed using reference databases of the human oral and intestinal microbiomes. Statistical analyses will be performed using an alpha level of 0.05 (p < 0.05).
연구 유형
등록 (실제)
단계
- 초기 1단계
연락처 및 위치
연구 장소
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São Paulo
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Ribeirão Preto, São Paulo, 브라질, 14040-904
- Universidade de São Paulo
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Adults with a diagnosis of generalized periodontitis, defined as involvement of ≥30% of teeth, classified as: Stage III or Stage IV, and Grade B or Grade C, according to the 2018 classification.
- Presence of at least one tooth with ≥1 interproximal site exhibiting: Probing depth (PD) ≥6 mm, and Clinical attachment loss (CAL) ≥5 mm.
- Presence of at least 15 teeth, excluding third molars and teeth indicated for extraction.
- Presence of at least 6 non contiguous teeth, each with ≥1 interproximal site presenting PD and CAL ≥5 mm.
Exclusion Criteria:
- Current smokers or former smokers who quit less than 5 years prior to enrollment.
- Pregnant or breastfeeding women.
- History of periodontal treatment within the previous 6 months.
- Continuous use of oral antiseptics within the last 6 months.
- Use of systemic antibiotics, corticosteroids, non steroidal anti inflammatory drugs, immunosuppressants, estrogen, estrogen receptor modulators, or medications affecting bone metabolism (e.g., alendronate, calcitonin) within the last 6 months.
- Presence of systemic conditions that may alter the host response, including: Diabetes mellitus, HIV infection, Down syndrome.
- Medical conditions requiring antibiotic prophylaxis for dental procedures (e.g., mitral valve prolapse).
- Known allergy or hypersensitivity to amoxicillin, metronidazole, penicillins, or related compounds.
- Use of probiotics within the last 6 months.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: 위약
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실험적: Probiotic
To compare the effects of probiotic as an adjuvant therapy
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Patients will receive probiotic lozenges as an adjuvant therapy to periodontal treatment.
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실험적: Antibiotic
To compare the effects as an adjuvant therapy
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The antibiotic group will receive amoxicilin and metronidazole, the probiotic group will receive probiotics
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Periodontal Probing Depth (PD)
기간: every 3 months, up to 1 year
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A full-mouth periodontal examination will be performed using a North Carolina periodontal probe (Hu-Friedy, Chicago, IL, USA).
Probing depth (PD) will be measured in millimeters at six sites per tooth.
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every 3 months, up to 1 year
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Clinical Attachment Level (CAL)
기간: Every 3 months, up to 1 year
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Clinical attachment level (CAL) will be measured in millimeters at six sites per tooth using a North Carolina periodontal probe.
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Every 3 months, up to 1 year
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Bleeding on Probing (BOP)
기간: Every 3 months, up to 1 year
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Bleeding on probing will be assessed dichotomously (presence/absence) at six sites per tooth during full-mouth periodontal examination
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Every 3 months, up to 1 year
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Visible Supragingival Biofilm
기간: Every 3 months, up to 1 year
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Presence or absence of visible supragingival biofilm will be assessed on four tooth surfaces during full-mouth periodontal examination.
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Every 3 months, up to 1 year
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Distance from Cementoenamel Junction to Gingival Margin
기간: Every 3 months, up to 1 year
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The distance from the cementoenamel junction to the gingival margin will be measured in millimeters at six sites per tooth.
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Every 3 months, up to 1 year
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Suppuration
기간: Every 3 months, up to 1 year
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Suppuration will be assessed dichotomously (presence/absence) at six sites per tooth during periodontal examination.
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Every 3 months, up to 1 year
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공동 작업자 및 조사자
수사관
- 연구 책임자: Michel Reis Messora, PhD, University of Sao Paulo
간행물 및 유용한 링크
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
- 75898223.7.0000.5419
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
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