A Study in Dentinal Hypersensitivity (DH) Participants to Assess the Efficacy of an Occluding Dentifrice.
2018년 7월 26일 업데이트: GlaxoSmithKline
A Clinical Study Investigating the Efficacy of Two Experimental Oral Rinses in Providing Long Term Relief From Dentinal Hypersensitivity
This study will investigate the longitudinal efficacy of two experimental oral rinses, one containing 1.5% weight/weight (w/w) dipotassium oxalate monohydride (KOX) /0 Parts per Million (ppm fluoride) and the other 2.0% w/w KOX /45ppm fluoride, for the relief of dentinal hypersensitivity (DH), compared to a placebo oral rinse, when used as an adjunct to twice daily brushing with a standard fluoride toothpaste.
연구 개요
상태
완전한
정황
연구 유형
중재적
등록 (실제)
240
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Indiana
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Fort Wayne, Indiana, 미국, 46825
- GSK Investigational Site
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Inclusion Criteria:
- Participants in good general health with no clinically significant/ relevant abnormalities in medical history or upon oral examination
- Pre-existing self reported and clinically diagnosed tooth sensitivity
- At screening a minimum of 20 natural teeth and at least two accessible, non-adjacent teeth (incisors, canines or pre-molars) preferably in different quadrants with a signs of facial/cervical gingival recession and/or signs of erosion or abrasion (EAR),tooth with modified gingival index (MGI) score =0 adjacent to the test area (exposed dentine) only and a clinical mobility of ≤1 and tooth with signs of sensitivity measured by qualifying evaporative air assessment (Y/N response).
- At baseline, a minimum of 2 non-adjacent accessible teeth (incisors, canines or premolars) with DH (qualifying tactile threshold Yeaple ≤ 20g, Schiff Sensitivity Score ≥ 2)
Exclusion Criteria:
- Participants with a known or suspected intolerance or hypersensitivity to study products
- Presence of chronic debilitating disease which could affect study outcomes
- Any condition which is causing dry mouth
- Use of an oral care product indicated for the relief of dentine hypersensitivity
- Participation in a DH treatment study in the 8 weeks prior to screening
- Taking daily doses of a medication/ treatment which could interfere with perception of pain or is causing dry mouth
- Require antibiotic prophylaxis for dental procedures
- Dental prophylaxis within 4 weeks of screening
- Treatment of periodontal disease within 12 months of screening
- Scaling or root planning within 3 months of screening
- Tooth bleaching within 8 weeks of screening
- Active caries or periodontitis
- Partial dentures, orthodontic appliances or dental implants which could affect study outcomes
- Pregnant and breast-feeding females
- Main Exclusions for Test Teeth: evidence of current or recent caries; treatment of decay within 12 months of screening; teeth with exposed dentine but with deep, defective or facial restorations; teeth used as abutments for fixed or removable partial dentures; teeth with full crowns or veneers, orthodontic bands or cracked enamel; sensitive teeth with contributing aetiologies other than erosion, abrasion or recession
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Experimental Oral Rinse 2
Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 ml of Experimental Oral Rinse 2 for 1 minute.
This regimen will be performed twice daily for 8 weeks.
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Oral rinse containing 1000ppm fluoride as sodium monofluorophosphate
Oral rinse containing 2.0% w/w KOX, 45ppm F, pH 4.5
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위약 비교기: Placebo Oral Rinse
Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 ml of Placebo Oral Rinse 2 for 1 minute.
This regimen will be performed twice daily for 8 weeks.
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Oral rinse containing 1000ppm fluoride as sodium monofluorophosphate
Oral rinse containing 0% w/w KOX 0ppm F, pH 4.5
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실험적: Experimental Oral Rinse 1
Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 ml of Experimental Oral Rinse 1 for 1 minute.
This regimen will be performed twice daily for 8 weeks.
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Oral rinse containing 1.5% w/w KOX, 0ppm F, pH 4.5
Oral rinse containing 1000ppm fluoride as sodium monofluorophosphate
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change From Baseline in Schiff Sensitivity Score of Experimental Oral Rinses 1 and 2 Against a Placebo Oral Rinse at Week 8
기간: Baseline, Week 8
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The examiner assessed the participant's response to an evaporative air stimulus for each selected two teeth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.
A reduction in Schiff Sensitivity score indicate improvement in sensitivity.
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Baseline, Week 8
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change From Baseline in VRS of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse) at Week 8
기간: Baseline, Week 8
|
Participants rated the intensity of their response to the evaporative (air) stimulus using a 10 point VRS.
The Participants were asked to rate their pain on a scale of 1 ("No Pain") to 10 ("Intense Pain").
A reduction in the score is indicative of an improvement in sensitivity.
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Baseline, Week 8
|
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Change From Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 at Week 8
기간: Baseline, Week 8
|
The examiner assessed the participant's response to an evaporative air stimulus for each selected two teeth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.
A reduction in Schiff Sensitivity score indicate improvement in sensitivity.
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Baseline, Week 8
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Change From Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse at Week 4
기간: Baseline, Week 4
|
The examiner assessed the participant's response to an evaporative air stimulus for each selected two teeth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.
A reduction in Schiff Sensitivity score indicate improvement in sensitivity.
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Baseline, Week 4
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Change From Baseline in Tactile Threshold (Gram [g]) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 4
기간: Baseline, Week 4
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The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force has reached.
The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort.
The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold.
The higher the tactile threshold, the less sensitive the tooth.
At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.
However, in situations where participants did not give a 'yes' response at force of 80g, the tactile threshold was recorded as >80g.
For analysis purposes values recorded as >80g were treated as 90g values.
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Baseline, Week 4
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Change From Baseline in Tactile Threshold (g) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 8
기간: Baseline, Week 8
|
The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force has reached.
The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort.
The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold.
The higher the tactile threshold, the less sensitive the tooth.
At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.
However, in situations where participants did not give a 'yes' response at force of 80g, the tactile threshold was recorded as >80g.
For analysis purposes values recorded as >80g were treated as 90g values.
|
Baseline, Week 8
|
|
Change From Baseline in Visual Rating Scale (VRS) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 4
기간: Baseline, Week 4
|
Participants rated the intensity of their response to the evaporative (air) stimulus using a 10 point VRS.
The Participants were asked to rate their pain on a scale of 1 (No Pain) to 10 (intense Pain).
A reduction in the score is indicative of an improvement in sensitivity.
|
Baseline, Week 4
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2015년 9월 8일
기본 완료 (실제)
2015년 12월 1일
연구 완료 (실제)
2015년 12월 18일
연구 등록 날짜
최초 제출
2016년 4월 25일
QC 기준을 충족하는 최초 제출
2016년 4월 25일
처음 게시됨 (추정)
2016년 4월 27일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 8월 27일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 7월 26일
마지막으로 확인됨
2018년 7월 1일
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