Evaluation of Toothpaste Effect in Volunteers With Dental Sensitivity
Comparative Clinical Trial to Evaluate the Efficacy of a Toothpaste in Subjects With Dental Hipersensitivity
The goal of this study is to learn if a toothpaste alone and together with mouthwash works to alleviate teeth hypersensitivity in adults. It will also learn about the safety of the product.
The main question it aims to answer is:
• Does the toothpaste help to improve signs of teeth hypersensitivity? Researchers will compare sensitive teeth toothpaste and use of sensitive teeth and mouthwash to a regular toothpaste to see if it works to improve teeth sensitivity.
Participants will:
- Use assigned products daily for 14 days
- Visit the clinic on the established days during 14 days for check-ups and evaluation
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
Barcelona, 스페인
- Hospital Odontológico Universidad de Barcelona - Bellvitge
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Healthy female and male participants (no specific gender distributions required)
- Aged 18 years or older
- Participants presenting dental hyperesthesia with at least two hypersensitive teeth with a verbal rating scale (VRS) score greater than or equal to 1 after tactile stimulation, and a Schiff Cold Air Sensitivity Scale score greater than or equal to 1 at the initial visit (T0).
- Participants certifying the truthfulness of the personal data disclosed to the investigator.
- Participants able to understand the language used at the investigation centre and comprehend the information provided by the investigator.
- Participants able to follow the instructions provided by the investigator and comply with the study requirements and restrictions.
- Pharmacological therapy (except for therapies listed under non-inclusion criteria) must have been stable for at least one month, with no changes expected or planned during the study
- Commitment by the participants not to change the daily routine or lifestyle during the study.
- Participants who have not taken part in any other similar clinical study in the previous six months.
- Commitment by the participant not to use other oral hygiene products containing fluoride or ingredients such as hydroxyapatite during the study period.
Exclusion Criteria:
- Participants currently participating or planning to participate in other clinical trials.
- Participants deprived of liberty by administrative or judicial decision or under guardianship.
- Participants who cannot be contacted in the event of an emergency.
- Participants admitted to a healthcare or social institution.
- Participants planning hospitalization during the study period.
- Participants who have taken part in a similar study without respecting an adequate washout period (defined as the use of desensitizing agents within the last six months).
- Participants under pharmacological treatments that modify the evaluation of dental sensitivity or are incompatible with the requirements of the study.
- Participants with a history of active caries within the past 12 months or at risk for developing caries (e.g., multiple dental restorations, crowns with compromised margins) per examiners discretion.
- Participants with known allergies or sensitivities to any components of the investigational product.
- Women who are breastfeeding, pregnant, or unwilling to take the adequate contraceptive measures to avoid pregnancy during the study (for women of childbearing potential).
- Participants with acute, chronic, or progressive pathologies (including diabetes, cardiovascular and metabolic conditions) incompatible with the study requirements.
- Any tooth surface adjacent to those surfaces under investigation that in the opinion of the investigator have any other condition that produce symptoms confounding the evaluation of cervical dentin hypersensitivity.
- Participants with a medical history or taking medication, or wearing physical items (e.g., orthodontic braces) that could interfere with the study.
- Participants with a history of illegal drug use.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
활성 비교기: 일반 치약
|
Toothpaste was used two times a day (after meals) during 14 days
|
|
실험적: Desensitizing toothpaste
|
Toothpaste was used two times a day (after meals) during 14 days
|
|
실험적: Desensitizing toothpaste with mouthwash
|
Toothpaste and mouthwash were used two times a day (after meals) during 14 days
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Change from Baseline in dentine sensitivity comparing desensitizing toothpaste versus active comparator at 14 days
기간: From enrollment to the end of use at 14 days
|
From enrollment to the end of use at 14 days
|
2차 결과 측정
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Change in dentine sensitivity from baseline in dentine sensitivity comparing desensitizing toothpaste group versus desensitizing toothpaste and mouthwash group at day 14.
기간: From baseline to day 14
|
From baseline to day 14
|
|
Change from baseline in pH at 14 days
기간: From baseline to day 14
|
From baseline to day 14
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (실제)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- ES0000395/2024
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .