- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01592864
The Efficacy of a Dentifrice in Providing Relief From the Pain of Dentinal Hypersensitivity
A Clinical Study Investigating the Efficacy of a Dentifrice in Providing Long Term Relief From Dentinal Hypersensitivity
연구 개요
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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Nevada
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Las Vegas, Nevada, 미국, 89121
- BioSci Research America, Inc.
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Subjects who suffer from tooth sensitivity
Inclusion Criteria:
- none
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 |
---|---|
실험적: 팔 1
불화주석 함유 치약
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dentifice
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활성 비교기: 팔 2
모노플루오르인산나트륨을 함유한 시판 치약
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dentifrice
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Week 8
기간: Baseline to 8 weeks post administration of study treatment
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Response to a constant jet of air applied to hypersensitive teeth is evaluated using a Schiff Sensitivity pain response scale.
According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus.
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Baseline to 8 weeks post administration of study treatment
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Week 4
기간: Baseline to 4 weeks post administration of study treatment
|
Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale.
According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus.
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Baseline to 4 weeks post administration of study treatment
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Adjusted Mean Change From Baseline in Tactile Sensitivity Pain Response at Week 8
기간: Baseline to 8 weeks post administration of study treatment
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Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. The constant pressure probe allowed the examiner to vary the force applied to the dentin surface from 10 grams (g) to an upper threshold of 80 g, in increments of 10g since the values below represents adjusted mean change in baseline, the value can fall below scale range. The greater the pressure the subject was able to tolerate, the less. Change from baseline in tactile response to Week 8 was calculated. sensitive the tooth. According to this tactile sensitivity assessment, an increasing force was applied to hypersensitive tooth until a yes response is recorded or the maximum force has been reached. |
Baseline to 8 weeks post administration of study treatment
|
Adjusted Mean Change From Baseline in Tactile Sensitivity Pain Response at Week 4
기간: Baseline to 4 weeks post administration of study treatment
|
Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale.
The constant pressure probe allowed the examiner to vary the force applied to the dentin surface from 10g to an upper threshold of 80g, in increments of 10g.
The greater the pressure the subject was able to tolerate, the less sensitive the tooth.
According to this tactile sensitivity assessment, an increasing force was applied to hypersensitive tooth until a yes response is recorded or the maximum force has been reached.
Change from baseline in tactile response to Week 4 was calculated
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Baseline to 4 weeks post administration of study treatment
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공동 작업자 및 조사자
스폰서
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 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. .
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