Innovative Mouthwash in School-Aged Children With Fixed Orthodontic Appliances
Laboratory and Clinical Evaluation of an Innovative Mouthwash in School-Aged Children With Fixed Orthodontic Appliances
Fixed metal orthodontic appliances create additional plaque-retentive areas around brackets, archwires and ligatures, making mechanical plaque control more difficult in children and adolescents. Increased plaque accumulation may contribute to gingival inflammation, bleeding, halitosis and early enamel changes. Therefore, adjunctive preventive agents, including mouthwashes, may be clinically useful as part of a comprehensive oral hygiene program during fixed orthodontic treatment.
The aim of the study is to evaluate the clinical effectiveness and tolerability of a test mouthwash in children and adolescents with fixed orthodontic appliances by monitoring plaque accumulation, gingival inflammation, gingival bleeding and halitosis.
연구 개요
상태
정황
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Tanya Zalamova
- 전화번호: 00359878752567
- 이메일: Tanya.Zalamova@mu-plovdiv.bg
연구 연락처 백업
- 이름: Ani Belcheva, PhD
- 이메일: abeltcheva@gmail.com
연구 장소
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Plovdiv, 불가리아, 4000
- Department of Paediatric dentistry, Faculty of Dental Medicine, Medical University of Plovdiv
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연락하다:
- Tanya Zalamova
- 전화번호: 00359878752567
- 이메일: Tanya.Zalamova@mu-plovdiv.bg
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수석 연구원:
- Zalamova
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Participants aged 12 to 17 years.
- Presence of fixed metal orthodontic appliances placed at least 6 months before enrollment.
- Generalized plaque-induced gingivitis.
- Full Mouth Bleeding Score greater than 30%.
- Gingival Index greater than 0.95 according to Loe and Silness.
- Written informed consent obtained from a parent or legal guardian.
- Participant willingness to comply with the study protocol.
Exclusion Criteria:
- Refusal to participate or withdrawal of informed consent.
- Non-compliance with the intervention regimen or inability to attend follow-up visits.
- Development of an adverse reaction or condition requiring discontinuation.
- Antibiotic or antimicrobial therapy during follow-up if it may affect the study outcomes.
- Presence of concomitant systemic diseases.
- Current systemic medication intake that could influence oral health or inflammatory status.
- Use of systemic or local antimicrobial agents during the previous 3 months, including mouthwashes, gels, chewing gums or other local oral agents.
- Known allergy or hypersensitivity to any component of the tested mouthwash formulations.
- Use of removable orthodontic appliances only. Inability or unwillingness to follow the study instructions.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Test Mouthwash
Participants rinsed with 15 ml of the prototype chlorhexidine-free pediatric mouthwash for 30-60 seconds twice daily for 21 days as an adjunct to standard oral hygiene.
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Participants rinsed with a 15 ml prototype chlorhexidine-free pediatric mouthwash for 30-60 s twice daily for 21 days as an adjunct to standard oral hygiene.
다른 이름들:
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활성 비교기: Chlorhexidine Mouthwash
Participants rinsed with a 15 ml chlorhexidine-containing mouthwash for 30-60 s twice daily for 21 days as an adjunct to standard oral hygiene.
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Participants rinsed with a 15 ml chlorhexidine-containing mouthwash for 30-60 s twice daily for 21 days as an adjunct to standard oral hygiene.
다른 이름들:
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위약 비교기: Placebo Mouthwash Group
Participants rinsed with 15 ml of the placebo mouthwash for 30-60 seconds twice daily for 21 days as an adjunct to standard oral hygiene.
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Participants rinsed with a 15 ml placebo mouthwash for 30-60 s twice daily for 21 days as an adjunct to standard oral hygiene.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Orthodontic Plaque Index (OPI)
기간: Baseline, day 7, day 21, and 3 months
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The Orthodontic Plaque Index focuses on the areas around the bracket, which represents an additional plaque-retentive factor. The dentition is divided into sextants and plaque accumulation is scored from 0 to 4. The mesial, distal, incisal and cervical areas around each bracket are evaluated. The highest score among all sextants defines the oral hygiene level and identifies the need for preventive measures. Registry field data Code 0 No plaque accumulation is detected. Code 1 Plaque accumulation is detected on one tooth surface around the bracket base. Code 2 Plaque accumulation is detected on two tooth surfaces around the bracket base. Code 3 Plaque accumulation is detected on three tooth surfaces around the bracket base; increased risk of caries and gingivitis is assumed. Code 4 Plaque accumulation is detected on all tooth surfaces around the bracket base and/or gingival inflammation is present. |
Baseline, day 7, day 21, and 3 months
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Gingival Index (Loe & Silness)
기간: Baseline, day 7, day 21, and 3 months
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The index evaluates color, contour and bleeding of the gingival tissues. A World Health Organization (WHO) 621 periodontal probe is used to examine the gingival sulcus, and bleeding is recorded within 10 seconds. Code 0 Normal gingiva. Code 1 Mild inflammation: slight color change and slight edema, without bleeding on probing. Code 2 Moderate inflammation: redness, edema and glazing, with bleeding on probing. Code 3 Severe inflammation: marked redness and edema, ulceration and tendency to spontaneous bleeding. |
Baseline, day 7, day 21, and 3 months
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Full Mouth Bleeding Score (FMBS)
기간: Baseline, day 7, day 21, and 3 months
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FMBS assesses provoked bleeding from the gingival sulcus using a WHO 621 periodontal probe.
Bleeding is recorded within 10 seconds and marked as present (+) or absent (-).
The index is calculated as the percentage of gingival sites with provoked bleeding from all examined sites for each child.
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Baseline, day 7, day 21, and 3 months
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Full Mouth Plaque Score (FMPS)
기간: Baseline, day 7, day 21, and 3 months
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Dental plaque accumulation was assessed using the Full Mouth Plaque Score.
The presence of visible plaque was recorded on tooth surfaces, and the result was expressed as the percentage of plaque-positive sites.
Lower percentages indicate improved plaque control.
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Baseline, day 7, day 21, and 3 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Halitosis Assessment
기간: Baseline, day 7, day 21, and 3 months
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Halitosis was assessed by gas chromatography using OralChroma™.
Volatile sulfur compounds were measured, including hydrogen sulfide, methyl mercaptan and dimethyl sulfide.
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Baseline, day 7, day 21, and 3 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Tanya Zalamova, Plovdiv Medical University
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
- 17/2024
- 02/2024 (기타 식별자: Medical University Plovdiv)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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