Clinical Evaluation of a Toothpaste for Dental Plaque Reduction and Prevention of Gum Problems
Clinical Evaluation of a Stannous Fluoride Toothpaste Versus a 67% Bicarbonate Toothpaste and Colgate Cavity Protection Toothpaste for Dental Plaque Reduction and Prevention of Gum Problems: a Six-month Clinical Study in Italy
Qualified subjects will be enrolled and randomized to either one of the three study groups described above based on their initial modified gingivitis and plaque scores. Subjects will be instructed to use the products according to the instructions provided. Subjects will return to the dental office for evaluation after three months and six months of product use. All subjects will be followed for adverse events throughout the study.
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 3단계
연락처 및 위치
연구 연락처
- 이름: Luigi Montensani, DDS
- 전화번호: +39-338-6187383;
- 이메일: luigi@montensani.it
연구 장소
-
-
Rome
-
Roma, Rome, 이탈리아, 00187
- 모병
- Clinica Odontoiatrica Montesani
-
연락하다:
- Luigi Montesani, MD, DDS
- 전화번호: +39-338-6187383
- 이메일: luigi@montesani.it
-
수석 연구원:
- Luigi Montesani, MD, DDS
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Subjects, ages 18-70, inclusive.
- Availability for the six-month duration of the study.
- Good general health.
- Initial gingivitis index of at least 1.5 as determined by the use of the Modified Gingivitis Index.
- Initial plaque index of at least 1.5 as determined by the use of the Modified Quigley-Hein Plaque Index.
- Signed Informed Consent Form
Exclusion Criteria:
- Orthodontic bands.
- Tumor(s) of the soft or hard tissues of the oral cavity.
- Advanced periodontal disease (purulent exudate, tooth mobility), and/or
- Extensive loss of periodontal attachment or alveolar bone.
- Five or more carious lesions requiring immediate restorative treatment
- Use of antibiotics any time during the one month prior to entry into the study.
- Participation in any other clinical study or test panel within the one month prior to entry into the study.
- Received a dental prophylaxis in the two weeks prior to your initial examination.
- History of allergies to oral care/personal care consumer products or their ingredients.
- Having taken any prescription medicines that might interfere with the study outcome.
- If you with an existing medical condition which prohibits you from not eating or drinking for periods of up to 4 hours.
- Self-reported pregnant or breast feeding an infant.
- History of drug abuse
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Test 1 toothpaste
Approximately, 1.5 grams (full ribbon covering the head of toothbrush) of toothpaste shall be used for each brushing, 2 times daily (morning and evening) for 2 minutes each time |
toothpaste |
|
활성 비교기: Positive Control
Approximately, 1.5 grams (full ribbon covering the head of toothbrush) of toothpaste shall be used for each brushing, 2 times daily (morning and evening) for 2 minutes each time |
toothpaste |
|
활성 비교기: Negative Control
Approximately, 1.5 grams (full ribbon covering the head of toothbrush) of toothpaste shall be used for each brushing, 2 times daily (morning and evening) for 2 minutes each time |
Toothpaste with MFP/NaF (1450 F) |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Lobene Modified Gingivitis Assessment
기간: Baseline, 3 month, 6 month
|
Modified Gingivitis Index score from 0 to 4 will be assigned by the examining dentist to all tooth surfaces using a dental light and dental mirror. A whole mouth mean score for each subject will be determined by adding the values given by the examining dentist to each scoreable surface and dividing that number by the total number of surfaces scored |
Baseline, 3 month, 6 month
|
|
Saxton Gingival Bleeding Assessment
기간: Baseline, 3 month, 6 month
|
Gingival bleeding is assessed 30 seconds after probing; a score of 0 represents an absence of bleeding, a score of 1 is given if bleeding is observed within 30 seconds after probing and a score of 2 is given if bleeding is observed immediately on probing |
Baseline, 3 month, 6 month
|
|
Modified Quigley-Hein Plaque Index
기간: Baseline, 3 month, 6 month
|
First using a red dye solution to disclose the plaque, a Modified Quigley-Hein Plaque Index score of 0 to 5 will be assigned to all scoreable disclosed tooth surfaces using a dental light and dental mirror. A whole mouth score for each subject will be determined by adding the values given by the dental examiner to each scoreable surface and dividing that number by the total number of surfaces scored. |
Baseline, 3 month, 6 month
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Luigi Montensani, DDS, Clinica Odontoiatrica Montesani
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CRO-2026-07-PGN-GAD-ITA-YPZ
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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. .