A Study to Investigate Efficacy of Two Experimental Oral Rinses in Providing Long Term Relief From Pain Derived From Exposed Dentine in Response to Chemical, Thermal, Tactile, or Osmotic Stimuli.
2018年7月26日 更新者:GlaxoSmithKline
A Clinical Study Investigating the Efficacy of Two Experimental Oral Rinses in Providing Long Term Relief From Dentinal Hypersensitivity
This will be a single center, eight week, randomized, double blind, three treatment arm, parallel design, stratified (by mean baseline Schiff Sensitivity Score of the two selected test teeth) study in healthy participants.
調査の概要
状態
完了
条件
研究の種類
介入
入学 (実際)
221
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Indiana
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Fort Wayne、Indiana、アメリカ、46825
- GSK Investigational Site
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年~65年 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
Inclusion Criteria:
- Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- Participants will be male or female aged between 18 and 65 years inclusive.
- Good general and mental health with, in the opinion of the investigator or medically qualified designee.
No clinically significant and relevant abnormalities in medical history or upon oral examination.
Absence of any condition that would impact on the participant's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements.
- Self-reported history of dentinal hypersensitivity (DH) lasting more than(>) six months but not > 10 years.
- Good general oral health, with a minimum of 20 natural teeth.
- Minimum of 2 accessible non-adjacent teeth (incisors, canines, pre-molars), preferably in different quadrants at screening and minimum of two, non-adjacent accessible teeth (incisors, canines, pre-molars) at baseline.
Exclusion Criteria:
- Women who are pregnant or breast-feeding .
- Daily doses of medication/treatments which, in the opinion of the Investigator, could interfere with the perception of pain. Examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilisers, anti-depressants, mood-altering and anti-inflammatory drugs.
- Currently taking antibiotics or has taken antibiotics within two weeks of Baseline.
- Daily dose of a medication which, in the opinion of the investigator, is causing xerostomia.
- Presence of kidney disease, hyperoxaluria, or any other condition that may be exacerbated by oxalic acid or oxalate salts.
- Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes.
- Any condition which, in the opinion of the investigator, causes xerostomia.
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit.
- Previous participation in this study.
- Recent history (within the last year) of alcohol or other substance abuse.
- Dental prophylaxis within four weeks of Screening, tongue or lip piercing or presence of dental implants.
- Desensitizing treatment within eight weeks of Screening (professional sensitivity treatments and non-toothpaste sensitivity treatments).
- Gross periodontal disease, treatment of periodontal disease (including surgery) within 12 months of Screening, scaling or root planning within 3 months of Screening.
- Teeth bleaching within eight weeks of Screening.
- Tooth with evidence of current or recent caries, or reported treatment of decay within 12 months of Screening.
- Tooth 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 of exposed dentine.
- Sensitive tooth not expected to respond to treatment with an over-the-counter toothpaste in the opinion of the Investigator.
- Use of an oral care product indicated for the relief of dentine hypersensitivity within eight weeks of screening.
- Individuals who require antibiotic prophylaxis for dental procedures.
- Any participant who, in the judgment of the investigator, should not participate in the study.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的:Experimental Oral Rinse 1 (1.5% w/w KOX, 0ppm F, pH 7.0)
Participants will apply a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brush their teeth for one timed minute and expectorate.
They will then rinse with 20ml of tap water (using the dosing cap provided) for 10 seconds and expectorate, then rinse with 10ml of the experimental oral rinse 1 (using the second dosing cap provided) for one timed minute and expectorate.
No further rinsing will be allowed.
This regimen will be performed twice daily for 8 weeks.
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1.5% w/w KOX, 0ppm F, pH 7.0
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実験的:Experimental Oral Rinse 2 (2.0% w/w KOX, 45ppm F, pH 4.5)
Participants will apply a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brush their teeth for one timed minute and expectorate.
They will then rinse with 20ml of tap water (using the dosing cap provided) for 10 seconds and expectorate, then rinse with 10ml of the experimental oral rinse 2 (using the second dosing cap provided) for one timed minute and expectorate.
No further rinsing will be allowed.
This regimen will be performed twice daily for 8 weeks.
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2.0% w/w KOX, 45ppm F, pH 4.5
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プラセボコンパレーター:Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )
Participants will apply a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brush their teeth for one timed minute and expectorate.
They will then rinse with 20ml of tap water (using the dosing cap provided) for 10 seconds and expectorate, then rinse with 10ml of the placebo oral rinse (using the second dosing cap provided) for one timed minute and expectorate.
No further rinsing will be allowed.
This regimen will be performed twice daily for 8 weeks.
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0% w/w KOX 0ppm F, pH 4.5
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change From Baseline in Schiff Sensitivity Score at Week 8 (Treatment 1 and 2 Versus [vs.] Placebo)
時間枠:Baseline and Week 8
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Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth, response of participant was scored using Schiff sensitivity scale range of 0-3; 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 requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.
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Baseline and Week 8
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change From Baseline in Schiff Sensitivity Score at Week 8 (Treatment 1 vs. Treatment 2)
時間枠:Baseline and Week 8
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Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth, response of participant was scored using Schiff sensitivity scale range of 0-3; 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 requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.
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Baseline and Week 8
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Change From Baseline in Schiff Sensitivity Score at Week 4
時間枠:Baseline and Week 4
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Schiff sensitivity score was assessed as participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth, using scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of syimulus; 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.
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Baseline and Week 4
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Change From Baseline in Tactile Threshold at Week 4 and 8
時間枠:Baseline, Week 4 and 8
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Pressure was administered using a constant pressure probe (Yeaple Probe).
The constant pressure probe allows the examiner to vary the force applied to the dentine surface from 10 g to an upper threshold of 80g in increments of 10 g.
The tactile threshold is the maximum pressure applied without the participant reporting pain or discomfort.
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 greater the tactile threshold, the less sensitive the tooth.
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Baseline, Week 4 and 8
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Change From Baseline in Visual Rating Scale (VRS) at Week 4 and 8
時間枠:Baseline, Week 4 and 8
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Participants rated the intensity of their response to the evaporative (air) stimulus using a 10 point VRS.
The subjects were asked to rate their pain on a scale of 1 ("No Pain") to 10 ("Intense Pain").
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Baseline, Week 4 and 8
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スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2016年1月4日
一次修了 (実際)
2016年4月1日
研究の完了 (実際)
2016年4月22日
試験登録日
最初に提出
2016年1月7日
QC基準を満たした最初の提出物
2016年1月7日
最初の投稿 (見積もり)
2016年1月11日
学習記録の更新
投稿された最後の更新 (実際)
2018年8月27日
QC基準を満たした最後の更新が送信されました
2018年7月26日
最終確認日
2018年7月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。