- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00743548
Comparing the Inter-dental Brush to Dental Floss
Comparison of Inter-dental Brush to Dental Floss for Reduction of Plaque and Bleeding in Areas With Intact Papilla: A Clinical Trial
연구 개요
상태
정황
상세 설명
Purpose:
To determine if the interdental brush is just as effective at removing plaque and reducing bleeding gums between the teeth as dental floss.
Rationale:
Many people find dental floss difficult to use and thus, do not floss daily to maintain oral health and prevent gum disease. These individuals may find the interdental brush easier to use and may be motivated to use it daily for optimal oral health.
Study design:
Study subjects will use the dental floss AND the interdental brush for 12 weeks. Plaque and bleeding scores will be measured before the study begins (week 0), mid-way (week 6), and at the end of the 12 weeks. All study subjects receive a teeth cleaning prior to the first measurements and oral hygiene instructions on how to floss and use the interdental brush. Subjects will also answer 4 short questions about their product preference and ease of use.
Study subjects:
32 healthy adult volunteers with bleeding gums. To be included in the study, subjects require 8 bleeding sites, 4 areas that can accommodate the interdental brush, dexterity to dental floss, and willingness to come for 4 study visits. Exclusion criteria include smokers because this can affect the bleeding scores; individuals with braces (orthodontia) which affects plaque levels; individuals using chlorhexidine which is a prescription strength mouthwash used to treat moderate to severe gum disease; pregnant women; and those individuals requiring antibiotics prior to dental appointments. Enrolled study subjects receive a teeth cleaning (value $180), $75 for completing the study, and all study related supplies.
연구 유형
등록 (예상)
단계
- 3단계
연락처 및 위치
연구 장소
-
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British Columbia
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Vancouver, British Columbia, 캐나다, V6T 1Z3
- University of British Columbia Nobel Biocare Oral Health Centre
-
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Adults
- Minimum of 4 interproximal areas that can accommodate a minimum 0.6 mm interdental brush width
- Minimum of 8 interproximal bleeding sites upon stimulation
- Dexterity to use manual waxed dental floss
- Able to attend all 4 study visits
Exclusion Criteria:
- Require premedication with antibiotics prior to dental therapy
- Use chlorhexidine or over-the-counter mouthwash during the study
- Smoke
- Have orthodontia
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 단일 그룹 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: 1
Interdental brush (IB), the intervention is a small multi-tufted brush on a wire attached to a long angled handle that is inserted in a horizontal plane between the teeth.
The IB is inserted once and removed.
|
IB is a small multi-tufted brush on a wire attached to a long angled handle that is inserted in a horizontal plane between the teeth.
The IB is inserted once and removed.
|
|
위약 비교기: 2
Dental floss (DF), the positive control, is waxed dental floss; nylon covered with a water soluble unflavoured wax to facilitate easier access the contact points of teeth.
DF is rubbed against the interproximal surfaces of the teeth 2-4 times on each surface.
|
DF is waxed dental floss; nylon covered with a water soluble unflavoured wax to facilitate easier access the contact points of teeth.
DF is rubbed against the interproximal surfaces of the teeth 2-4 times on each surface.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Plaque and bleeding reduction
기간: 12 weeks
|
12 weeks
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Product preference between dental floss and interdental brush
기간: 12 weeks
|
12 weeks
|
공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Pauline Imai, MSc., University of British Columbia
- 연구 책임자: Penny Hatzimanolakis, University of British Columbia
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- H08-01078
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .