"Efficacy of a New Carbonate/Hydroxyapatite Nanocrystal Dentifrice on the Dental Plaque Index and the de Novo Plaque Formation Rate in Individuals Suffering From Gingivitis and/or Periodontitis"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 主要终点
- Primary outcome plaque formation rate (PFR) was measured 24 hours after all teeth were treated mechanically.
研究概览
简要总结
This 12-week prospective, randomized, double-blind, two-center trial evaluated the impact of a microcrystalline zinc-hydroxyapatite (mHA) dentifrice on plaque formation rate (PFR) in periodontitis patients. The investigators hypothesized that mHA precipitates cause delayed plaque development when compared to a fluoridated control (AmF/SnF2), and therefore would improve periodontal health.
详细描述
Study Objectives and Purpose The purpose of this study is to assess the clinical efficacy of a new dentifrice, containing carbonate/hydroxyapatite nanocrystals (BioRepair®, Kurt Wolff, Bielefeld, Germany), in subjects suffering from severe gingivitis and/or mild to moderate chronic periodontitis and receiving non-surgical periodontal therapy. Clinical efficacy will be evaluated regarding clinical and microbiological parameters and compared to the use of a zinc-fluoride containing dentifrice (Meridol®, GABA, Lörrach, Germany) serving as a positive control.
Research Questions
This three-month clinical trial is conducted to answer the following research questions:
Primary Question
- Is there a difference in de novo plaque formation as measured by the Plaque Formation Rate Index (Axelsson 1991) between subjects using the new carbonate/hydroxylapatite nanocrystal dentifrice and those using the established zinc-fluoride containing control dentifrice? Secondary Questions
- Are there differences between subjects using the two dentifrices with respect to their subjective perception of therapy?
- Are there differences between the two dentifrices with respect to the following periodontal measurements: change of full mouth plaque scores (O'Leary Plaque Control Record, O'Leary 1972), gingival index (Löe 1967), change of pocket probing depths (PPD's), and the percentage of sites with attachment gain of ≥ 2 mm?
- Are there qualitative and quantitative changes regarding the composition of the oral microflora?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pocket probing depths (PPDs) of ≥ 4 mm at a minimum of four teeth (except third molars)
- •age ≤ 18 to ≤ 75 years
- •at least 10 natural teeth in situ (except third molars)
- •non-smokers
排除标准
- •known systemic diseases that may influence the periodontal conditions
- •regular consumption of drugs that may interfere with periodontal conditions
- •undergoing or requiring extensive dental or orthodontic treatment
- •pregnancy or breastfeeding
- •professional periodontal therapy during 6 months prior to baseline.
- •periodontal pockets ≥ 6 mm in more than 2 sextants
结局指标
主要结局
Primary outcome plaque formation rate (PFR) was measured 24 hours after all teeth were treated mechanically.
时间窗: Measured 24 hours after all teeth were treated mechanically .
For the recording of PFR,all teeth were stained with a plaque revealer (Mira 2-Ton® Miradent, Hager \& Werken GmbH, Duisburg, Germany).
次要结局
- full mouth plaque control record (PCR, O'Leary 1972).(at baseline (visit 2a), after 4 weeks and after 12 weeks)
- bleeding on probing (BOP, Lang et al. 1990),(at baseline (visit 2a), after 4 weeks and after 12 weeks)
- gingival recession (GR)(at baseline (visit 2a), after 4 weeks and after 12 weeks)
- gingival index (GI, Löe 1967),(at baseline (visit 2a), after 4 weeks and after 12 weeks)
- pocket probing depths (PPD)(at baseline (visit 2a), after 4 weeks and after 12 weeks)
研究者
Benjamin Ehmke
Prof. Dr.
University Hospital Muenster