Oil Pulling Whitening Mouthwash
2026년 6월 18일 업데이트: Bennett Amaechi, The University of Texas Health Science Center at San Antonio
Evaluation of Tooth Whitening Efficacy of GuruNanda Oil Pulling Oral Rinse.
The goal of this study is to evaluate the tooth whitening efficacy of Oil Pulling oral rinse compared to a competitor's whitening mouthwash and a water-based mouthwash (placebo).
Each participant will use one of three mouthwashes: GuruNanda Oil Pulling oral rinse (test), Competitor's mouthwash (positive), Water-based oral rinse (placebo).
All mouthwashes will be used once daily last thing before bed at night.
Data will be collected on tooth shade evaluated on the anterior teeth.
연구 개요
상태
모병
정황
상세 설명
A total of 120 subjects who met all necessary requirements for selection as subjects will be stratified into three balanced groups (40 per group) according to age, gender, and their mean baseline tooth shade measured using the VITA Easy Shade Advance Spectrophotometer.
Males and females aged between 18 and 60 years will be enrolled.
The three groups will be randomly assigned to use one of three test mouthwashes: GuruNanda Oil Pulling oral rinse (test), Competitor's mouthwash (positive), Water-based oral rinse (placebo).
Subjects will be instructed to use their assigned mouthwash as an adjunct oral hygiene product for the 8-week treatment duration.
All subjects will be provided with the same brand of toothpaste (non-antimicrobial) and a soft-bristled toothbrush to use for their routine daily toothbrushing for the 8-week treatment duration.
All study products will be used according to their manufacturers' instructions.
However, to facilitate double blinding, only the Randomizer will dispense the products, give instructions on the use of the products, and supervise the first use of the product at the clinical facility.
The clinical Examiner and other study team members will not discuss product-use with the subjects.
All mouthwash will be used once daily before bed at night, while toothbrushing will be performed twice daily in the morning and before bed at night.
For each test subject, assessment data will be collected at baseline, 4 weeks, and 8 weeks.
Data will be collected on tooth shade evaluated using the Lobene Stain Index, VITA Bleachedguide 3D-Master shade guide and the Vita EasyShade® Advance 4.0 Spectrophotometer on the anterior teeth.
The average summary scores will be calculated for each group on each of these measurements.
All dental examinations for data collection in all 120 subjects will be conducted by the same Clinical Examiner throughout the study.
Subjects will be examined and queried on adverse events at each study visit.
연구 유형
중재적
등록 (추정된)
120
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Bennett T Amaechi, BDS, MS, PhD, MFDS RCPS, FADI
- 전화번호: 210-567-3185
- 이메일: amaechi@uthscsa.edu
연구 연락처 백업
- 이름: Razina Vohra
- 전화번호: 210-643-9803
- 이메일: vohrar@uthscsa.edu
연구 장소
-
-
Texas
-
San Antonio, Texas, 미국, 78229
- 모병
- Clinical Research Facility of the Center for Oral Health and Research, UTHSA
-
연락하다:
- Bennett T Amaechi, BDS, MS, PhD, MFDS RCPS, FADI
- 전화번호: 210-567-3185
- 이메일: amaechi@uthscsa.edu
-
연락하다:
- Razina Vohra
- 전화번호: 210-643-9803
- 이메일: vohrar@uthscsa.edu
-
-
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
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Adult subjects aged 18-60, that are in good health.
- Subject must have at least 2 natural anterior teeth, each having a mean Lobene composite score of ≥ 1.5 on the facial surfaces as assessed by the Investigator.
- Subject's front teeth shade should be 9 or darker (meaning shade score should be between 9 and 29), as assessed by the Vita bleachguide 3D-Master and the Vita EasyShade device.
- Subjects should understand the information provided about the investigative nature of the treatment, possible benefits and side effects. Subjects will sign the Informed Consent Form.
- The subjects should be willing to comply with the study procedure and schedule, including the follow up visits, and will refrain from using any other teeth whitening technologies during this period.
- The subject did not perform any procedure for teeth whitening (either at home or in clinic) at least 3 years prior to participating in the study.
Exclusion Criteria:
- Pregnant or nursing by subject report.
- Known allergic reaction to any of the study mouthwashes or any of their components. Participant has completed the screening questionnaire (Exclusion due to Known Allergens).
- Any active condition in the oral cavity at the discretion of the investigator.
- Any surgery or dental procedure in the treated area within 3 months prior to treatment, or before complete healing.
- Subjects that do not brush regularly.
- Any condition that might make it unsafe for the subject to participate in the study, at the discretion of the investigator.
- Heavy tobacco use, including cigarettes, cigars, or smokeless tobacco.
- Consumption of stain-causing substances (e.g., red wine, coffee, tea) that cannot be avoided during the study period.
- Use of medications that may affect tooth discoloration (e.g., tetracyclines, chlorhexidine).
- Participation in another clinical trial within the last 30 days.
- Presence of orthodontic appliances, except for removable retainers.
- Signs of advanced enamel wear, dentin exposure, or tooth fractures.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: 양성 대조군
|
positive control
|
|
위약 비교기: 음성 대조군
|
negative control
|
|
실험적: 테스트 제품
|
Test product
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Measurement by the VITA Easyshade Advance 4.0
기간: Baseline to 8 weeks
|
A probe tip is placed on an area of the enamel surface that has underlying dentin and a measurement made of the shade
|
Baseline to 8 weeks
|
|
VITA Bleachguide 3-D Master Shade Guide
기간: Baseline to 8 weeks
|
A single examiner will perform visual tooth shade assessment under standard lighting conditions.
Tooth shade will be scored on selected anterior teeth .
The tab marking system includes interpolated shade guide units (sgu) ranging from 1 to 29 sgu with a lower score indicating more whitening.
Subject shade rank scores will be determined for each visit by calculating the mean value across the selected anterior teeth scored.
|
Baseline to 8 weeks
|
|
Lobene Stain Index
기간: Baseline to 8 weeks
|
Measure of intensity and extent of extrinsic stain on the facial surfaces of 12 anterior teeth.
The teeth are divided into regions which are scored separately.
Intensity is scored from 0 (no stain) to 3 (heavy stain; dark brown to black) and extent is scored from 0 (no stain) to 3 (stain covering over two-thirds of the region).
Scores will be averaged for each subject for intensity (sum of all intensity scores/all sites graded) and extent (sum of all extent scores/all sites graded), and the composite stain score calculated by multiplying the mean stain intensity by the mean stain extent.
|
Baseline to 8 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Satisfaction: Subjective participant questionnaires
기간: 8 weeks
|
Front teeth appearance: Five subjects will be selected from each study group for this purpose.
A digital imaging system, camera (Canon EOS 50D), will be used.
The camera (Canon EOS 50D) is to be attached to a standardized head positioner to allow for consistency between images.
A digital exposure will be made with include lips/cheeks retracted and anterior teeth aligned edge to edge.
Another digital exposure will also be made with the subjects smiling but covering just the area between nose and chin.
Photographs will be taken as digital images before the treatment and at the final study visit when efficacy assessments are completed.
Lighting conditions will be as described for the tooth shade assessments to ensure uniformity among subjects and consistency across time.
|
8 weeks
|
|
Satisfaction Questionnaire
기간: 8 weeks
|
A questionnaire containing 6 scorable items with a potential score of (a) 5=Very High to (e)1=Very Low and 4 free response questions.
Total scores range from 6-30 with a higher score indicating greater satisfaction
|
8 weeks
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
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 (실제)
2026년 5월 1일
기본 완료 (추정된)
2026년 8월 31일
연구 완료 (추정된)
2026년 8월 31일
연구 등록 날짜
최초 제출
2026년 6월 18일
QC 기준을 충족하는 최초 제출
2026년 6월 18일
처음 게시됨 (실제)
2026년 6월 24일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 24일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 18일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- STUDY00001211
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
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. .