Assessment of Therapeutic Potential of a Novel Dental Probiotic in Pediatric Patients Affected by Gingivitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Reduction in gingivitis
研究概览
简要总结
This study investigates the efficacy of a proprietary probiotic formulation comprising 6 strains of bacteria in reducing inflammation and gingivitis in pediatric patients between 11 and 18 years old undergoing orthodontics treatment. Patients will be recruited based on a prior diagnosis of mild to moderate gingivitis by gingival index score. Participants in this study will be randomly assigned to receive either the probiotic treatment or a placebo, both in the form of a dissolving lozenge; for which the placebo is exactly the same shape, texture, taste, and composition as the probiotic treatment, but does not contain the active probiotic ingredients. The lozenges are to be taken orally at a certain prescribed regimen for 28 days. Participants will be assessed for gingivitis scores, gum bleeding scores, plaque scores, overall periodontal health, and for precarious areas at baseline, 14, and 28 days. They will also be assessed for the same measures at day 56, following a 28-day wash-out phase. Plaque and saliva samples will be collected at all timepoints for in vitro analyses of changes in microbial pathogens and/or inflammatory cytokines.
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
- 11 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are male or female between the ages of 11 to 18 years
- •Have mild to moderate gingivitis as determined by dentist (GI of at least 1 to a maximum of 2)
- •Are undergoing fixed orthodontic therapy on both arches with attachments on at least 20 teeth including bonded 1st molars for a minimum of 5 months.
- •Have fully erupted teeth #16, #21, #23, #36, #41, and #43
- •Are caries inactive prior to study initiation.
- •Are in a healthy systemic condition
- •Have not used any antimicrobial mouth rinses, probiotics (unrelated to the study), antibiotics or anti-inflammatories medications with one month prior to and during the study
- •Whose legal guardian has given informed consent to participate in the study and must be able to communicate in English
排除标准
- •Unable to make informed consent
- •Subjects with allergies to milk or milk products, gluten or soy or any other ingredients present in the lozenge
- •Immune compromised
- •Major underlining medical condition
- •Pregnancy
- •History of smoking or alcohol consumption
- •Have major dental conditions such as periodontal disease, dental caries and/or xerostemia or systemic diseases which could directly or indirectly affect plaque formation
- •Use of medications within 1 month (antibiotics, anti-inflammatory, mouth rinses) that can influence the outcome.
- •Ongoing or recent (within 1 month) use of probiotics unrelated to the study
- •Have within the past 30 days experienced any nausea, fever, vomiting, bloody diarrhea or severe abdominal pain
研究组 & 干预措施
Probiotic formulation
Probiotic dissolving lozenge, at least 1 billion total CFU, taken at a certain prescribed regimen for 28 days.
干预措施: Probiotic formulation (Dietary Supplement)
Placebo
Placebo dissolving lozenge, with the exact same appearance as the treatment lozenge (including flavour, colour, shape and texture), and formulated with all the same ingredients except for the live bacteria, taken for 28 days at the same prescribed regimen as the probiotic lozenge.
干预措施: Probiotic formulation (Dietary Supplement)
结局指标
主要结局
Reduction in gingivitis
时间窗: 0, 14, 28, and 56 days
Gingivitis will be assessed by gingival index: 0 - Absence of gingival inflammation 1. \- Mild inflammation: slight change in colour, little change in texture of any portion of but not the entire marginal or papillary gingival unit 2. \- Mild inflammation: criteria as above, but involving the entire marginal or papillary gingival unit 3. \- Moderate inflammation: glazing, redness, edema, and/or hypertrophy of the marginal or papillary gingival unit 4. \- Severe inflammation: marked redness, edema, and/or hypertrophy of marginal or papillary gingival unit; spontaneous bleeding, congestion or ulceration.
次要结局
- Reduction in inflammation(0, 14, 28, and 56 days)
- Reduced plaque(0, 14, 28, and 56 days)
研究者
Peter Cadieux
Adjunct Professor
University of Western Ontario, Canada