Impact of a Newly Formulated Tooth Paste in the Prevention/Elimination of Tooth Staining Associated With Adjunctive Use Chlorhexidine Mouth Rinses to Subgingival Instrumentation. A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Tooth Staining
研究概览
简要总结
Dental staining may interfere with compliance with chlorhexidine mouth rinse use
Thus, developing strategies to control tooth staining associated with chlorhexidine use may be relevant for improving compliance. Thus, a new anti-staining toothpaste formulation (Dentaid, Barcelona, Spain) has been recently developed, aiming to interfere with the development of extrinsic staining associated with chlorhexidine use (preventive action), but also with the capacity of removing staining already formed. For that, the proposed formulation includes hexametaphosphate, tripolyphosphate and polyvinylpyrrolidone (PVP), within its ingredients. Thus, it may be relevant to test the efficacy of this new anti-staining toothpaste formulation in two consecutive randomized clinical trials (RCTs).
Objectives The primary objective of these RCTs will be to evaluate the capacity of preventing tooth staining, associated with the use of a chlorhexidine mouth rinse, adjunctive to subgingival instrumentation (step 2 of periodontal therapy) (RCT #1). As secondary objective, the capacity of eliminating or reducing tooth staining already present will be assessed (RCT #2).
详细描述
The primary objective of these RCTs will be to evaluate the capacity of preventing tooth staining, associated with the use of a chlorhexidine mouth rinse, adjunctive to subgingival instrumentation (step 2 of periodontal therapy) (RCT #1). As secondary objective, the capacity of eliminating or reducing tooth staining already present will be assessed (RCT #2).
Additional objectives will include to test: (1) the safety of the tested formulation, in terms of adverse events and tolerability; (2) patient´s evaluation of the product, by means of patient-reported outcome measures (PROMs); and (3) clinical impact of the tested formulation in terms of periodontal clinical outcomes.
Consecutive subjects, referred to the Post-Graduate Periodontal Clinic in the University Complutense, Madrid, seeking for treatment of periodontitis in stages I-III will be screened, and enrolled in the clinical trials if they fulfil the following criteria and accept to participate by filling an informed consent
Two consecutive parallel, double-blind, randomized, placebo-controlled, 2-week, clinical trials have been designed.
Screening visit After completing a questionnaire including the subject's medical health status, medication and smoking habit [smoker defined when currently smoking ≥ 9 cigarettes per day], a careful oral health evaluation will be carried out. If subjects met the inclusion/exclusion criteria, the investigator will inform them about the aims and details of the study and will request their voluntary participation. Once they accept, by signing the Institutional Review Board (IRB) approved informed consent form, they will be enrolled in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
test and placebo toothpastes would be identical
入排标准
- 年龄范围
- 30 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •30-69 years old.
- •Periodontitis patients, in stages I-III, requiring steps 1 and 2 of periodontal treatment including full-mouth subgingival instrumentation.
- •Systemically healthy, following the criteria of the American Society of Anesthesiologists (ASA), for patients ASA type I or II (see also
排除标准
- •Presence of at least three evaluable teeth in each quadrant.
- •No orthodontic banding or removable prosthesis.
- •Subjects willing to participate and comply with the requirements of the study.
- •Exclusion Criteria:
- •Acute periodontal conditions.
- •Antibiotic intake within the previous month.
- •Chronic use of analgesic or anti-inflammatory drugs.
- •Pregnant women.
- •Any adverse medical history (diabetes, osteoporosis, immunosuppression…) or long-term medication (chemotherapy and immunosuppression treatment; pharmacological treatment associated with gingival overgrowth such as the use of phenytoin, phenobarbital, lamotrigine, vigabatrin, ethosuximide, topiramate, primidone, nifedipine, amlodipine, verapamil, cyclosporine) influencing gingival conditions.
- •Conditions which require antibiotic prophylaxis (infectious endocarditis, cardiac valve prosthesis…).
研究组 & 干预措施
Control-Control
Immediately after the second session of subgingival instrumentation (initial visit, RCT #1) subjects will be randomly assigned to one of two groups, test or placebo.
0-2 weeks: The control group will use three times daily a provided manual toothbrush with the placebo toothpaste (identical to the test tooth paste, but without the active ingredients), followed by the use, twice daily, of a 0.12% chlorhexidine mouth rinse.
Subjects will stop using the mouth rinse, and will start the second RCT, being randomized again, within each group of the first RCT, to the placebo or test toothpaste.
2-4 weeks: The control group will use three times daily a provided manual toothbrush with the placebo toothpaste (identical to the test tooth paste, but without the active ingredients), followed by the use, twice daily, of a 0.12% chlorhexidine mouth rinse.
干预措施: Toothpaste without hexametaphosphate, tripolyphosphate and polyvinylpyrrolidone (PVP) (Other)
Control-test
Immediately after the second session of subgingival instrumentation (initial visit, RCT #1) subjects will be randomly assigned to one of two groups, test or placebo.
0-2 weeks: The control group will use three times daily a provided manual toothbrush with the placebo toothpaste (identical to the test tooth paste, but without the active ingredients), followed by the use, twice daily, of a 0.12% chlorhexidine mouth rinse.
Subjects will stop using the mouth rinse, and will start the second RCT, being randomized again, within each group of the first RCT, to the placebo or test toothpaste.
2-4 weeks: The experimental group will use three times daily a provided manual toothbrush with the test toothpaste (Dentaid, Barcelona, Spain), followed by the use, twice daily, of a 0.12% chlorhexidine, commercially available, mouth rinse.
干预措施: Toothpaste with hexametaphosphate, tripolyphosphate and polyvinylpyrrolidone (PVP) (Other)
Test-control
Immediately after the second session of subgingival instrumentation (initial visit, RCT #1) subjects will be randomly assigned to one of two groups, test or placebo.
0-2 weeks: The experimental group will use three times daily a provided manual toothbrush with the test toothpaste (Dentaid, Barcelona, Spain), followed by the use, twice daily, of a 0.12% chlorhexidine, commercially available, mouth rinse.
Subjects will stop using the mouth rinse, and will start the second RCT, being randomized again, within each group of the first RCT, to the placebo or test toothpaste.
2-4 weeks: The control group will use three times daily a provided manual toothbrush with the placebo toothpaste (identical to the test tooth paste, but without the active ingredients), followed by the use, twice daily, of a 0.12% chlorhexidine mouth rinse.
干预措施: Toothpaste with hexametaphosphate, tripolyphosphate and polyvinylpyrrolidone (PVP) (Other)
Test-test
Immediately after the second session of subgingival instrumentation (initial visit, RCT #1) subjects will be randomly assigned to one of two groups, test or placebo.
0-2 weeks: The experimental group will use three times daily a provided manual toothbrush with the test toothpaste (Dentaid, Barcelona, Spain), followed by the use, twice daily, of a 0.12% chlorhexidine, commercially available, mouth rinse.
Subjects will stop using the mouth rinse, and will start the second RCT, being randomized again, within each group of the first RCT, to the placebo or test toothpaste.
2-4 weeks: The experimental group will use three times daily a provided manual toothbrush with the test toothpaste (Dentaid, Barcelona, Spain), followed by the use, twice daily, of a 0.12% chlorhexidine, commercially available, mouth rinse.
干预措施: Toothpaste with hexametaphosphate, tripolyphosphate and polyvinylpyrrolidone (PVP) (Other)
结局指标
主要结局
Tooth Staining
时间窗: 4 weeks
GRÜNDEMANN MODIFIED STAIN INDEX (GMSI) (Gründemann et al., 2000). 2. Photographs of buccal and lingual/palatal areas of lower and upper anterior teeth, from canine to canine. The zones to be scored, buccal only: Mesial (A), Distal (A), Gingival (G) and Incisal (I) The intensity in each zone will be scored using the following criteria described by Lobene (Lobene, 1968): Score=0 No stain Score=1 Light stain Score=2 Moderate stain Score=3 Heavy stain
Tooth Staining
时间窗: 2 weeks
GRÜNDEMANN MODIFIED STAIN INDEX (GMSI) (Gründemann et al., 2000). 2. Photographs of buccal and lingual/palatal areas of lower and upper anterior teeth, from canine to canine. The zones to be scored, buccal only: Mesial (A), Distal (A), Gingival (G) and Incisal (I) The intensity in each zone will be scored using the following criteria described by Lobene (Lobene, 1968): Score=0 No stain Score=1 Light stain Score=2 Moderate stain Score=3 Heavy stain
次要结局
- Gingival condition(4 weeks)
- Probing depth (PD)(4 weeks)
- Compliance(4 weeks)
- Recession (REC)(4 weeks)
- Patient-reported outcome measures (PROMs)(4 weeks)
- Dental plaque(4 weeks)
- Dental plaque(0 weeks)
- Compliance(2 weeks)
- Dental plaque(2 weeks)
- Gingival condition(0 weeks)
- Probing depth (PD)(0 weeks)
- Recession (REC)(0 weeks)
- Patient-reported outcome measures (PROMs)(2 weeks)