Clinical Comparison of a Postbiotic-gel With Placebo Gel for Gingival Inflammation in Patients With Down Syndrome: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in Bleeding on Probing (BOP%)
研究概览
简要总结
The aim of the study is to evaluate the efficacy of home treatment with a postbiotic-based gel for the management of periodontal inflammation in patients with Down syndrome.
Patients will be enrolled at the S.C. Odontostomatologia dell'Azienda Ospedaliera "Ordine Mauriziano di Torino", Turin, Italy. After the collection of the periodontal clinical indexes (BoP%, PCR%, dental mobility, mMGI, compliance and satisfaction questionnaire), patients will undergo a professional mechanical debridement with ultrasonic instruments and glycine powders.
Then, they will be randomly divided into two groups according to the home treatment:
- in the Trial group Biorepair Plus Parodontgel Intensive (containing microRepair®, hyaluronic acid, Lactobacillus Ferment and Aloe Barbadensis Leaf Juice Powder) will be used once a day for all the duration of the study
- in the Control group, a placebo gel without (active ingredients) will be used once a day for all the duration of the study.
Indexes will be re-evaluated after 1 (T1), 3 (T2) and 6 months. The professional mechanical debridement will be performed again at T3 timepoint.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •not bedridden patients with Down syndrome
- •gingival inflammation and bleeding
排除标准
- •lack of compliance signalled by caregivers
- •other systemic diseases
结局指标
主要结局
Change in Bleeding on Probing (BOP%)
时间窗: Baseline (T0), after 1 month (T1), 3 months (T2) and after 6 months (T3)
Dichotomous scoring (yes/no) of bleeding sites on 4 surfaces of teeth.
Change in Plaque Control Record (PCR%)
时间窗: Baseline (T0), after 1 month (T1), 3 months (T2) and after 6 months (T3)
% assessment of the amount of plaque on dental surfaces; it is detected on 4 surfaces: distal, mesial, vestibular, lingual / palatal. The number of sites with plaque is divided by the total number of sites available in the mouth and multiplied by 100. Results indicate the index as a percentage.
Change in product satisfaction
时间窗: Baseline (T0), after 1 month (T1), 3 months (T2) and after 6 months (T3)
* Product liking questionnaire: evaluation of taste, smell, consistency, persistence and ease of application by Visual Analogue Scale (VAS) and filling out a questionnaire to which a score from 0 to 10 is associated, of which: * 0: Insufficient; * 1 to 3: Sufficient; * 4 to 6: Good; * 7 to 9: Very Good; * 10: Excellent.
Change in Dental mobility
时间窗: Baseline (T0), after 1 month (T1), 3 months (T2) and after 6 months (T3)
Scoring criteria Grade 0: oscillation within 0.2 mm; the teeth move naturally and there are no mobility problems; Grade I: horizontal mobility of the tooth from 0.2 to 1 mm; Grade II: horizontal mobility of the tooth from 1 to 2 mm; Grado III: horizontal mobility equal to or greater than 3 mm or vertical mobility of the tooth.
Change in compliance
时间窗: Baseline (T0), after 1 month (T1), 3 months (T2) and after 6 months (T3)
Subjective evaluation of the patient's degree of compliance with the proposed treatment by Visual Analogue Scale (VAS), assessing compliance with dosage, alterations and modifications on lifestyle, and adherence to set recalls; to which is associated a score from 0 to 10 of which: * 0 to 2: Poor compliance; * 3 to 5: Sufficient compliance; * 6 to 8: Good compliance; * 9 to 10: Excellent compliance.
Change in Modified Gingival Index
时间窗: Baseline (T0), after 1 month (T1), 3 months (T2) and after 6 months (T3)
Scoring criteria (one measurement for each tooth: upper first incisors, first premolars/first primary molars and first molars): 0\. Absence of inflammation Mild inflammation (marginal or papillary unit) Mild inflammation (entire marginal and papillary unit) Moderate inflammation Severe inflammation
次要结局
未报告次要终点
研究者
Andrea Scribante
Associate Professor, Principal Investigator
University of Pavia