Prospective Double-Blind Randomized Controlled Clinical Trial in the Gingivitis Prevention With an Oligomeric Proanthocyanidins Nutritional Supplement
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Brightness of the Gingiva
研究概览
简要总结
Aim: To evaluate the effectiveness on tissue response of the new nutritional supplement made of Oligomeric Proanthocyanidins (OPCs) in induced gingivitis after 21 days of use.
Material and Methods: A double-blind randomized controlled prospective clinical trial was carried out on 20 patients divided into an experimental group treated with the OPCs pill and a control group treated with placebo, after fulfilling the selection criteria. Patients had to come 4 times during the study to register the Silness and Loe and Gingival Bleeding index, plaque index, inflammatory crevicular fluid study (IL6) and changes in brightness of the gingiva. No complementary hygiene methods were allowed during the 21 days.
详细描述
Material and Methods
Study Design and Population
A randomized, double-blind, placebo-controlled, clinical trial of 21 days of duration was conducted among 20 volunteer students of Dentistry of the University of Sevilla. No previous studies have been found in the literature, so 20 subjects were determined for the pilot study to test our hypothesis.
The study protocol was approved by the Ethics Committee of the University of Sevilla. Prior to participation, the purpose and procedures were fully explained to all patients and all participants gave written informed consent in accordance with Helsinki declaration. The study was designed, conducted, analysed and reported according to guidelines for Good Clinical Practice. The study was approved by the Clinical Trials.gov Protocol Registration and Results System with the number XXXXYY. The protocol can be accessed if necessary in ClinicalTrials.gov.
The study was carried out between September 2013 until January 2104. The recruitment started on September and the Baseline date took place on October 2013. After the 21 days follow-up, data was treated obtaining the results on January 2014.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects older than 18 years, male or female, good general health, a minimum of 20 teeth (teeth that have gross caries, were crowned or extensively restored, orthodontic banded, abutments, or third molars were not included in the tooth count), signed informed consent before study initiation.
排除标准
- •Periodontal disease, defined as 4 mm and / or positive bleeding on probing
- •Pregnant or breastfeeding
- •Subjects with fixed or removable prosthesis
- •Tumor pathology in oral cavity; Use of antibiotics during 2 months period prior to the start of the trial; Hypersensitivity to red fruits in general; Xerostomia; Active Smoker; Contagious-infectious pathologies; Pathology with severe systemic repercussions; Any other judgment of the investigator if he believes endangers or risk to the subject participant; Subjects with phenylketonuria or allergy to aspartame; Use of any oral hygiene product for the duration of the study.
结局指标
主要结局
Brightness of the Gingiva
时间窗: 21 days
The brightness of the gingiva was taken to identify possible changes in the gingival colour. The reddening of the gingiva accompanies the inflammation of the tissue, which is a factor that may help to differentiate inflammatory changes at this level. The luminosity of the gingiva was registered with Micro SpectroShadeTM MHT Optic Research AG. This instrument is designed for taking dental colour. However, besides including colour guides, the SpectroShadeTM has the ability to measure the brightness of any colour, not just shades of white. The change in the colour of the gingiva was observed within the same patient measuring the reference colour for each patient in the same point in each evaluation visit and being able to compare the change in the coloration of the same point.
Silness and Löe index
时间窗: 21days
Six teeth were examined according to Ramfjord criteria (16-21-24-36-41-44 ). Four surfaces of each tooth were examined, making a total of 24 measurements taken.
Gingival Bleeding index
时间窗: 21 days
A periodontal probe was used to make this index. The values established for the examination are found below: 0 - Absence of inflammation. 1 - Mild inflammation, slight change in colour and no gingival edema. No bleeding on probing. 2 - Moderate inflammation, redness, edema and gingival hypertrophy. Bleeds to probe (after 10 seconds). 3 - Severe inflammation, marked redness and hypertrophy. There may be ulcerations. Tends to spontaneous bleeding.
Turesky Plaque Index
时间窗: 21 days
The buccal surfaces of anterior teeth were examined using a mouthwash of basic fuchsine as developing agent plaque and a numerical scoring system from O to 5 was established. 0: There is no plaque 1: Independent streaks of plaque in the cervical margin of the tooth. 2: thin continuous band of plaque (up to 1mm) at the cervical margin. 3: Band greater than one millimetre wide, but covers less than one third of the crown. 4: The plate covers third but not more than two thirds of the crown. 5: The plate covers two thirds or more of the crown.
Inflammatory crevicular fluid study (IL6)
时间窗: 21 days
Crevicular fluid samples were collected from interdental areas (lingual, buccal, mesial, and distal) of six teeth distributed by the four quadrants (16, 21, 24, 36, 41 and 44) by 5 strips of pressed paper 2cm long, especially for crevicular fluid. The impregnation time for each patient was 5 seconds and immediately inserted into 0.5ml Eppendorf microtubes with 50ul saline at 4 ° C for preservation. The sample transport to the biological laboratory was in a refrigerator, being stored frozen at -80°C at the laboratory until being processed.
次要结局
未报告次要终点
研究者
ROSA MARÍA DÍAZ SÁNCHEZ
DENTIST - MASTER STUDENT
University of Seville