Evaluation of Antiplaque and Antigingivitis Effects of the New "Lacer Oros Acción Integral" Mouth Rinse Formulation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in BOP (Baseline-12 weeks)
研究概览
简要总结
Background; A new mouth rinse formulation ("Lacer Oros Acción Integral", Lacer SA, Barcelona, Spain) has been recently proposed, including O-Cymen-5-ol, potassium nitrate, zinc chloride, dipotassium glycyrrhizate, sodium fluoride, panthenol and xylitol, within its ingredients. Thus, it may be relevant to test the efficacy of this new "Lacer Oros Acción Integral" mouth rinse formulation in a RCT.
Primary Objective: The primary objective of this RCT will be to evaluate the antiplaque/antigingivitis effects of the test mouth rinse.
Population: Consecutive subjects in supportive periodontal therapy (SPT) will be screened at the Post-Graduate Periodontal Clinic in the University Complutense, Madrid, and enrolled in the clinical trial if they are periodontitis patients, already enrolled in a SPT, for at least 6 months, systemically healthy, with moderate gingival inflammation and complains of dentin hypersensitivity.
Study design: pilot, parallel, double-blind, randomized, placebo-controlled, 12-week, clinical trial
Intervention: The experimental group will use three times daily a provided manual toothbrush with a sodium fluoride dentifrice, followed by the use of the test mouth rinse (Lacer Oros Acción Integral - new formula, Barcelona, Spain). The control group will use three times daily a provided manual toothbrush with a sodium fluoride dentifrice, followed by the use of the control mouth rinse (Lacer Oros Acción Integral - new formula, without active ingredients, Barcelona, Spain).
Visits: Screening, baseline, 2 and 12 weeks.
Outcomes: Periodontal clinical outcomes (plaque levels, gingival condition, probing pocket depth), Stainign, Microbiological outcomes (culture and qPCR). Patient reported outcomes, compliance, adverse effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •35-64 years old.
- •Periodontitis patients, already enrolled in a SPT, for at least 6 months, and the last SPT visit in the previous 6 months.
- •Systemically healthy, following the criteria of the American Society of Anesthesiologists (ASA), for patients ASA type I or II (see also exclusion criteria).
- •Presence of at least three evaluable teeth in each quadrant.
- •Moderate gingival inflammation (≥40% bleeding on marginal probing, BOMP) (Van der Weijden, Timmerman, Nijboer, Reijerse, & Van der Velden, 1994) and Turesky plaque index ≥1.
- •Also 2017 World Workshop criteria and bleeding on probing (BOP) (Ainamo & Bay, 1975) criteria will be considered. The primary criteria will be BOP ≥30% and Turesky plaque index ≥1.5
- •No orthodontic banding or removable prosthesis.
- •Subjects willing to participate and comply with the requirements of the study.
- •Complains of dentin hypersensitivity in, at least, one evaluable tooth. Dentin hypersensitivity will be confirmed with evaporative sensitivity (Schiff et al., 1994), with a minimum score of 2-3 (West et al., 2013), although a score of 1 will also be considered as adequate. In order to be eligible, the selected tooth must not have a current desensitizing therapy, must not have been restored in the last 3 moths, or have a crown or a big restoration. Only incisors, canines and premolars will be considered (Holland, Narhi, Addy, Gangarosa, & Orchardson, 1997).
排除标准
- •Untreated or uncontrolled periodontitis
- •Regular use of antiseptic-containing and/or anti-hypersensitivity mouth rinses.
- •Antibiotic intake within the previous month.
- •Excessive exposure to acids (eating disorders, chronic regurgitation).
- •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 requires antibiotic prophylaxis (infectious endocarditis, cardiac valve prosthesis...).
结局指标
主要结局
Change in BOP (Baseline-12 weeks)
时间窗: Change from baseline to 12 weeks
Gingival Bleeding Index (Ainamo \& Bay, 1975), by dichotomously assessing bleeding after gentle probing.
次要结局
- Recession_6 weeks(6 weeks)
- Change in BOP (Baseline-6 weeks)(Change from baseline to 6 weeks)
- BOMP_baseline(Baseline)
- Change in BOMP (Baseline-6 weeks)(Change from baseline to 6 weeks)
- Dental Plaque_12 weeks(12 weeks)
- Change in BOP (6-12 weeks)(Change from 6 to 12 weeks)
- BOP_6 weeks(6 weeks)
- Change in Dental Plaque (Baseline-12 weeks)(Change from baseline to 12 weeks)
- Dental Plaque_Baseline(Baseline)
- Probing pocket depth_baseline(Baseline)
- Recession_12 weeks(12 weeks)
- Dentin hypersensitivity_baseline(Baseline)
- Dentin hypersensitivity_12 weeks(12 weeks)
- Patient reported outcomes-3_6 weeks(6 weeks)
- BOP_baseline(Baseline)
- Change in Dental Plaque (6-12 weeks)(Change from 6 to 12 weeks)
- Staining of teeth_12 weeks(12 weeks)
- Probing pocket depth_6 weeks(6 weeks)
- Recession_baseline(Baseline)
- Patient reported outcomes-2_12 weeks(12 weeks)
- Patient reported outcomes-4_12 weeks(12 weeks)
- Patient reported outcomes-5_12 weeks(12 weeks)
- Patient reported outcomes-6_6 weeks(6 weeks)
- Patient reported outcomes-9_12 weeks(12 weeks)
- BOP_12 weeks(12 weeks)
- Change in Dental Plaque (Baseline-6 weeks)(Change from baseline to 6 weeks)
- Dental Plaque_6 weeks(6 weeks)
- Patient reported outcomes-1_6 weeks(6 weeks)
- Total counts (CFU/ml)_Baseline(Baseline)
- BOMP_6 weeks(6 weeks)
- BOMP_12 weeks(12 weeks)
- Change in BOMP (Baseline-12 weeks)(Change from baseline to 12 weeks)
- Change in BOMP (6-12 weeks)(Change from 6 to 12 weeks)
- Staining of teeth_baseline(Baseline)
- Probing pocket depth_12 weeks(12 weeks)
- Patient reported outcomes-1_12 weeks(12 weeks)
- Patient reported outcomes-3_12 weeks(12 weeks)
- Staining of teeth_6 weeks(6 weeks)
- Dentin hypersensitivity_6 weeks(6 weeks)
- Patient reported outcomes-2_6 weeks(6 weeks)
- Patient reported outcomes-4_6 weeks(6 weeks)
- Patient reported outcomes-7_12 weeks(12 weeks)
- Patient reported outcomes-8_12 weeks(12 weeks)
- Patient reported outcomes-9_6 weeks(6 weeks)
- Total counts (CFU/ml)_12 weeks(12 weeks)
- Proportion of periodontal pathogens (%)_Baseline(Baseline)
- Patient reported outcomes-8_6 weeks(6weeks)
- Compliance_12 weeks(12 weeks)
- Patient reported outcomes-5_6 weeks(6 weeks)
- Patient reported outcomes-6_12 weeks(12 weeks)
- Patient reported outcomes-7_6 weeks(6 weeks)
- Compliance_6 weeks(12 weeks)
- Proportion of periodontal pathogens (%)_6 weeks(6 weeks)
- Total counts (CFU/ml)_6 weeks(6 weeks)
- Prevalence of periodontal pathogens (%) in each group_baseline(Baseline)
- Prevalence of periodontal pathogens (%) in each group_6 weeks(6 weeks)
- Prevalence of periodontal pathogens (%) in each group_12 weeks(12 weeks)
- Proportion of periodontal pathogens (%)_12 weeks(12 weeks)