Effects of a 50+ Toothpaste on Halitosis and Oral Comfort in Healthy Adults (HALI-50PLUS)
2026년 8월 18일 업데이트: Andrea Scribante, University of Pavia
Clinical, Instrumental, and Subjective Evaluation of the Anti-Halitosis Efficacy, Effects on Oral Comfort, and Sensory Acceptability of a 50+ Toothpaste Compared With a Standard Toothpaste in Orally Healthy Adults: A Randomized, Controlled, Double-Blind, Crossover Clinical Trial
The goal of this clinical trial is to compare a toothpaste designed for adults aged 50 years and older with a standard toothpaste in orally healthy adults. The main question is whether the 50+ toothpaste reduces bad breath more than the standard toothpaste after 14 days of twice-daily use. The study will also assess tongue coating, dry mouth symptoms, saliva production, oral comfort, oral health-related quality of life, taste, acceptability, and unwanted effects.
About 30 adults aged 18 to 65 years will take part. Each participant will use both toothpastes for 14 days each, in a randomly assigned order, with a 14-day break between the two treatment periods. Neither the participants nor the examiner performing the assessments will know which toothpaste is being used during each period.
At the study visits, bad breath will be measured using a device that detects volatile sulfur compounds in the mouth. Participants will also undergo an examination of the tongue, provide saliva samples, and complete questionnaires. Before each assessment visit, participants will be asked not to perform oral hygiene for 24 hours and to avoid food, drinks other than water, smoking, chewing gum, and oral care products for 3 to 4 hours.
연구 개요
상세 설명
This study will evaluate whether a toothpaste formulated for adults aged 50 years and older provides greater control of oral malodor and improved oral comfort compared with a standard commercially available fluoride toothpaste. Oral malodor will be assessed under standardized conditions using a reversible physiological model based on the temporary suspension of oral hygiene. No chemical substance will be used to induce malodor.
The study will use a randomized crossover design. Each participant will receive both study products in a randomly assigned sequence. Each treatment period will last 14 days and will be separated by a 14-day washout period, during which participants will return to their usual oral hygiene routine while avoiding products specifically intended for halitosis or dry mouth. Participants will brush twice daily for 2 minutes using only the assigned toothpaste. Tongue brushing and the use of mouthwashes or other products that could affect oral malodor or dry mouth will not be permitted during the treatment periods.
The test and control toothpastes will be supplied in neutral, indistinguishable packaging. Participants and the examiner responsible for the clinical and instrumental assessments will remain unaware of product identity. The treatment codes will be disclosed only after the study database has been finalized, unless disclosure is required for participant safety.
Assessments will be performed at baseline and after 7 and 14 days of each treatment period. Before each assessment, participants will suspend oral hygiene for 24 hours and follow standardized restrictions concerning food, beverages, smoking, chewing gum, and oral care products. This approach is intended to reduce measurement variability and allow each participant to serve as their own control.
연구 유형
중재적
등록 (추정된)
30
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Andrea Scribante, Associate Professor
- 전화번호: +39 0382516223
- 이메일: andrea.scribante@unipv.it
연구 장소
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Lombardy
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Pavia, Lombardy, 이탈리아, 27100
- Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
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연락하다:
- Andrea Scribante, Associate Professor
- 전화번호: +39 0382516223
- 이메일: andrea.scribante@unipv.it
-
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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
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
설명
Inclusion Criteria:
- Age between 18 and 65 years.
- Male or female.
- Orally healthy according to clinical examination, with no active oral condition that could interfere with study outcomes.
- At least 20 natural teeth.
- No active periodontitis.
- No clinically relevant untreated cavitated caries.
- No acute oral mucosal disease.
- Any existing systemic condition must be stable, controlled, and considered unlikely to interfere with the study outcomes.
- Willingness to use only the oral care products provided during each treatment period.
- Willingness to refrain from oral hygiene procedures for 24 hours before each assessment visit.
- Willingness to refrain from food, beverages other than water, smoking, chewing gum, candies, oral sprays, mouthwashes, and oral hygiene procedures for 3 to 4 hours before each assessment.
- Ability to understand the study objectives and procedures.
- Provision of written informed consent.
Exclusion Criteria:
- Active oral or dental disease that could interfere with the study outcomes. Active periodontitis.
- Periodontal probing depths greater than 3 mm at multiple sites, according to clinical judgment.
- Clinically relevant generalized gingival bleeding.
- Clinically relevant untreated cavitated caries.
- Oral candidiasis.
- Oral ulceration, stomatitis, symptomatic oral mucosal lesions, or acute oral infection.
- Clinical signs of severe xerostomia or pathological hyposalivation.
- Fewer than 20 natural teeth.
- Acute systemic disease or uncontrolled chronic systemic disease. Uncontrolled diabetes mellitus.
- Active autoimmune or systemic inflammatory disease.
- Gastrointestinal, respiratory, otorhinolaryngological, or metabolic conditions associated with clinically significant extraoral halitosis.
- Use of systemic antibiotics within 4 weeks before enrollment.
- Habitual use of antiseptic mouthwashes, anti-halitosis products, or dry-mouth products within 2 weeks before enrollment.
- Use of medications with a strong xerostomic effect that, in the investigator's judgment, could interfere with study outcomes.
- Smoking more than 10 cigarettes per day.
- Inability to refrain from smoking for 3 to 4 hours before assessment visits.
- Pregnancy or breastfeeding.
- Known or suspected allergy to any component of the study products.
- Professional dental cleaning or invasive dental procedures within 2 weeks before enrollment.
- Inability or unwillingness to comply with the study procedures.
- Participation in another clinical study within 4 weeks before enrollment.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 50+ Toothpaste Followed by Standard Toothpaste
Participants will use the 50+ toothpaste twice daily for 14 days, followed by a 14-day washout period.
They will then use the standard toothpaste twice daily for 14 days.
Each brushing session will last 2 minutes.
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A toothpaste formulated for adults aged 50 years and older.
Participants will use approximately 2 cm of toothpaste to brush their teeth for 2 minutes, twice daily, for 14 consecutive days.
The product will be supplied in neutral, coded packaging to maintain masking.
Participants will not use other toothpastes, mouthwashes, tongue-cleaning procedures, or products intended for halitosis or dry mouth during the treatment period.
다른 이름들:
A commercially available fluoride toothpaste intended for routine oral hygiene, without specific claims for halitosis or dry mouth and without ingredients specifically intended to neutralize volatile sulfur compounds.
Participants will use approximately 2 cm of toothpaste to brush their teeth for 2 minutes, twice daily, for 14 consecutive days.
The product will be supplied in neutral, coded packaging, and the same oral hygiene restrictions used for the 50+ toothpaste will apply.
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실험적: Standard Toothpaste Followed by 50+ Toothpaste
Participants will use the standard toothpaste twice daily for 14 days, followed by a 14-day washout period.
They will then use the 50+ toothpaste twice daily for 14 days.
Each brushing session will last 2 minutes.
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A toothpaste formulated for adults aged 50 years and older.
Participants will use approximately 2 cm of toothpaste to brush their teeth for 2 minutes, twice daily, for 14 consecutive days.
The product will be supplied in neutral, coded packaging to maintain masking.
Participants will not use other toothpastes, mouthwashes, tongue-cleaning procedures, or products intended for halitosis or dry mouth during the treatment period.
다른 이름들:
A commercially available fluoride toothpaste intended for routine oral hygiene, without specific claims for halitosis or dry mouth and without ingredients specifically intended to neutralize volatile sulfur compounds.
Participants will use approximately 2 cm of toothpaste to brush their teeth for 2 minutes, twice daily, for 14 consecutive days.
The product will be supplied in neutral, coded packaging, and the same oral hygiene restrictions used for the 50+ toothpaste will apply.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change From Baseline in Oral Volatile Sulfur Compound Concentration After 14 Days
기간: Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period
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Oral volatile sulfur compound concentration will be measured using a Halimeter Plus and expressed in parts per billion (ppb).
At each assessment, three valid consecutive measurements will be obtained, and their mean will be used for analysis.
For each treatment period, change from baseline will be calculated as the value after 14 days minus the baseline value.
Lower values and greater reductions indicate improvement in oral malodor.
The primary comparison will assess the within-participant difference in change between the 50+ toothpaste and the standard fluoride toothpaste.
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Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percentage Change From Baseline in Oral Volatile Sulfur Compound Concentration
기간: Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period
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Oral volatile sulfur compound concentration will be measured using a Halimeter Plus and expressed in parts per billion (ppb).
The percentage reduction will be calculated as: [(baseline value - follow-up value) / baseline value] × 100.
A higher positive percentage indicates a greater reduction in oral malodor.
Percentage changes obtained with the 50+ toothpaste and the standard fluoride toothpaste will be compared within participants.
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Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period
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Change From Baseline in Tongue Coating Severity Score
기간: Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period
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Tongue coating will be assessed clinically using a 4-point severity score: 0, no visible coating; 1, thin coating with the underlying mucosal color visible; 2, moderate coating; and 3, thick coating with marked mucosal coverage.
Lower scores indicate less tongue coating.
The predominant location of the coating will also be recorded as anterior, middle, posterior, or diffuse.
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Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period
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Change From Baseline in Participant-Reported Oral Malodor
기간: Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period
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Participants will rate their perceived oral malodor using an 11-point numerical rating scale ranging from 0 to 10, where 0 indicates no perceived bad breath and 10 indicates the worst perceived bad breath.
Lower scores indicate improvement.
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Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period
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Change From Baseline in Summated Xerostomia Inventory Score
기간: Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period
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Subjective dry mouth symptoms will be assessed using the 5-item Summated Xerostomia Inventory.
Each item is scored from 1, never, to 5, almost always.
The item scores are summed to produce a total score ranging from 5 to 25.
Higher scores indicate more severe subjective dry mouth symptoms.
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Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period
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Change From Baseline in Participant-Reported Oral Dryness
기간: Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period
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Participants will rate their perceived oral dryness using an 11-point numerical rating scale ranging from 0 to 10, where 0 indicates no oral dryness and 10 indicates the greatest possible oral dryness.
Lower scores indicate improvement.
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Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period
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Change From Baseline in Participant-Reported Oral Comfort
기간: Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period
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Participants will rate their overall oral comfort using an 11-point numerical rating scale ranging from 0 to 10, where 0 indicates no oral comfort and 10 indicates the greatest possible oral comfort.
Higher scores indicate better perceived oral comfort.
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Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period
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Change From Baseline in Oral Health Impact Profile-14 Total Score
기간: Baseline (T0) and after 14 days of treatment (T2) in each treatment period
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Oral health-related quality of life will be assessed using the 14-item Oral Health Impact Profile.
Each item is scored from 0, never, to 4, very often.
The scores are summed to obtain a total score ranging from 0 to 56.
Higher scores indicate a greater negative impact of oral health on quality of life.
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Baseline (T0) and after 14 days of treatment (T2) in each treatment period
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Change From Baseline in Unstimulated Salivary Flow Rate
기간: Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period
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Unstimulated whole saliva will be collected for 5 minutes using the spitting method.
The total collected volume will be divided by the collection duration and expressed in milliliters per minute (mL/min).
Higher values indicate a greater unstimulated salivary flow rate.
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Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period
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Change From Baseline in Stimulated Salivary Flow Rate
기간: Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period
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Stimulated whole saliva will be collected for 5 minutes using the spitting method after standardized gustatory stimulation with citric acid.
The total collected volume will be divided by the collection duration and expressed in milliliters per minute (mL/min).
Higher values indicate a greater stimulated salivary flow rate.
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Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period
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Overall Taste Pleasantness Score
기간: After 14 days of treatment (T2) in each treatment period
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Participants will rate the overall pleasantness of the toothpaste taste using a 9-point hedonic scale ranging from 1, extremely unpleasant, to 9, extremely pleasant.
Higher scores indicate greater taste pleasantness.
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After 14 days of treatment (T2) in each treatment period
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Perceived Freshness Score
기간: After 14 days of treatment (T2) in each treatment period
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Participants will rate the freshness perceived after brushing using an 11-point numerical rating scale ranging from 0, no perceived freshness, to 10, maximum perceived freshness.
Higher scores indicate greater perceived freshness.
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After 14 days of treatment (T2) in each treatment period
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Perceived Taste Persistence Score
기간: After 14 days of treatment (T2) in each treatment period
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Participants will rate the persistence of the toothpaste taste after brushing using an 11-point numerical rating scale ranging from 0, not persistent at all, to 10, extremely persistent.
Higher scores indicate greater perceived taste persistence.
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After 14 days of treatment (T2) in each treatment period
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Unpleasant Aftertaste Score
기간: After 14 days of treatment (T2) in each treatment period
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Participants will rate unpleasant aftertaste using an 11-point numerical rating scale ranging from 0, no unpleasant aftertaste, to 10, extremely unpleasant aftertaste.
Lower scores indicate better sensory acceptability.
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After 14 days of treatment (T2) in each treatment period
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Willingness to Continue Using the Toothpaste
기간: After 14 days of treatment (T2) in each treatment period
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Participants will rate their willingness to continue using the assigned toothpaste using an 11-point numerical rating scale ranging from 0, not willing at all, to 10, completely willing to continue its use.
Higher scores indicate greater willingness to continue using the product.
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After 14 days of treatment (T2) in each treatment period
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Participant-Reported Product Attribute Ratings
기간: After 14 days of treatment (T2) in each treatment period
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Participants will separately rate product odor, color, consistency, sensation of cleanliness, perceived effect on breath, perceived effect on oral dryness, lubricating effect, moisturizing effect, and willingness to reuse the product.
Each attribute will be rated using an 11-point numerical rating scale from 0 to 10 and analyzed separately without calculating a combined total score.
Higher scores indicate a more favorable assessment of each product attribute.
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After 14 days of treatment (T2) in each treatment period
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Incidence of Treatment-Emergent Adverse Events
기간: From the first product administration at T0 through the final assessment at T2 of the second treatment period, approximately 6 weeks
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The number and percentage of participants experiencing treatment-emergent adverse events will be recorded for each toothpaste.
Events of interest include oral burning, mucosal irritation, ulceration, taste alteration, nausea, increased oral dryness, hypersalivation, pain, and oral discomfort.
Each event will be classified according to intensity, seriousness, duration, relationship to the study product, and action taken.
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From the first product administration at T0 through the final assessment at T2 of the second treatment period, approximately 6 weeks
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Andrea Scribante, University of Pavia
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 (추정된)
2026년 10월 1일
기본 완료 (추정된)
2026년 12월 1일
연구 완료 (추정된)
2026년 12월 15일
연구 등록 날짜
최초 제출
2026년 8월 18일
QC 기준을 충족하는 최초 제출
2026년 8월 18일
처음 게시됨 (실제)
2026년 8월 21일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 21일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 18일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- HALI-50PLUS-2026
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
Data will be available upon motivated request to the corresponding authors.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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. .