Effect of the Consumption of Beverages Added With Stevia Rebaudiana on Oral pH and Dental Biofilm in Adolescents
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Mean salivary pH with natural water
研究概览
简要总结
The objective of this clinical trial is to compare the effect that the intake of beverages without sweeteners, added with non-caloric sweeteners (stevioside) and caloric sweeteners (sucrose) on oral pH and dental biofilm microbiome in Mexican adolescents.
Participants will drink on different occasions a beverage without sweetener, a beverage added with stevioside or a beverage added with sucrose. The researchers will compare the changes that each one causes in salivary pH, dental biofilm pH, dental biofilm bacterial proliferation and dental biofilm microbiome.
详细描述
A randomized crossover clinical trial will be conducted including 43 healthy adolescents participants (sample size with alpha=0.05 and beta=0.8 ). The intervention will consist of ingesting 250 mL of natural water (pH 7.1) in the first meeting, in subsequent meetings the natural water will be added with 1) 0.1 gr. of stevioside or 2) 25 gr. of sucrose. The washout period between interventions will be 1 week.
Participants will be informed of potential risks and those who sign the informed consent and complete the inclusion criteria will be randomized in a triple-blind manner.
The data will be collected in a special format including previous conditions, identification (age and sex) and possible adverse effects. If any possible adverse effect occurs, it will be notified to the research team to determine the changes.
- To determine the pH, saliva and dental biofilm samples will be obtained and analyzed using a HANNA potentiometer.
- To determine the bacterial proliferation, samples of dental biofilm will be obtained and the number of copies of Streptococcus mutans (S. mutans) and Streptococcus sobrinus (S. sobrinus) will be analyzed by polymerase reaction technique (PCR) of the 16S ribosomal gene fragment.
- To analyze dental biofilm microbiome, 11 of the 43 participants will be randomized for. Genetic sequencing will be performed and the amplicon Sequence Variants (ASVs) of S. mutans and S. sobrinus will be compared.
The data will be collected at a time indicated by a stopwatch and carried out by two verifiers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
colors will be assigned for each sweetener
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Habitual consumption of soft drinks
- •Decayed, Missing, and Filled Teeth (DMF) index of at least 3 (considering as caries those lesions that are visible without the tooth needing to be dry)
- •Agree to participate in the study and sign informed consent
- •Parents sign informed consent
- •Any nutritional condition
排除标准
- •Orthodontic treatment
- •Topical application of fluoride during the last 3 months
- •Having a motor disability that interfered with tooth brushing
- •Xerostomia
- •Antibiotic therapy during the study period
- •Periodontal infections
研究组 & 干预措施
Natural water
250 ml of natural water should be drunk
- Salivary pH will be analyzed at 0,5,10,15,30,45 and 60 minutes later
- Dental biofilm pH will be analyzed at 0,5,10,15,30,45 and 60 minutes later
- Streptococcus mutans and Streptoccus sobrinus proliferation in dental biofilm ( PCR copies) will be analyzed at 0 and 120 minutes later
- The relative abundance of Streptococcus mutans and Streptococcus sobrinus in dental biofilm will be analyzed using Amplicon Sequence Variant at 0 and 120 minutes later
干预措施: Stevioside (Drug)
Natural water
250 ml of natural water should be drunk
- Salivary pH will be analyzed at 0,5,10,15,30,45 and 60 minutes later
- Dental biofilm pH will be analyzed at 0,5,10,15,30,45 and 60 minutes later
- Streptococcus mutans and Streptoccus sobrinus proliferation in dental biofilm ( PCR copies) will be analyzed at 0 and 120 minutes later
- The relative abundance of Streptococcus mutans and Streptococcus sobrinus in dental biofilm will be analyzed using Amplicon Sequence Variant at 0 and 120 minutes later
干预措施: Sucrose (Drug)
Natural water
250 ml of natural water should be drunk
- Salivary pH will be analyzed at 0,5,10,15,30,45 and 60 minutes later
- Dental biofilm pH will be analyzed at 0,5,10,15,30,45 and 60 minutes later
- Streptococcus mutans and Streptoccus sobrinus proliferation in dental biofilm ( PCR copies) will be analyzed at 0 and 120 minutes later
- The relative abundance of Streptococcus mutans and Streptococcus sobrinus in dental biofilm will be analyzed using Amplicon Sequence Variant at 0 and 120 minutes later
干预措施: Natural water (Other)
Stevioside
250 ml of natural water added with 0.1 grams of stevioside should be drunk
- Salivary pH will be analyzed at 0,5,10,15,30,45 and 60 minutes later
- Dental biofilm pH will be analyzed at 0,5,10,15,30,45 and 60 minutes later
- Streptococcus mutans and Streptoccus sobrinus proliferation in dental biofilm ( PCR copies) will be analyzed at 0 and 120 minutes later
- The relative abundance of Streptococcus mutans and Streptococcus sobrinus in dental biofilm will be analyzed using Amplicon Sequence Variant at 0 and 120 minutes later
干预措施: Stevioside (Drug)
Stevioside
250 ml of natural water added with 0.1 grams of stevioside should be drunk
- Salivary pH will be analyzed at 0,5,10,15,30,45 and 60 minutes later
- Dental biofilm pH will be analyzed at 0,5,10,15,30,45 and 60 minutes later
- Streptococcus mutans and Streptoccus sobrinus proliferation in dental biofilm ( PCR copies) will be analyzed at 0 and 120 minutes later
- The relative abundance of Streptococcus mutans and Streptococcus sobrinus in dental biofilm will be analyzed using Amplicon Sequence Variant at 0 and 120 minutes later
干预措施: Sucrose (Drug)
Stevioside
250 ml of natural water added with 0.1 grams of stevioside should be drunk
- Salivary pH will be analyzed at 0,5,10,15,30,45 and 60 minutes later
- Dental biofilm pH will be analyzed at 0,5,10,15,30,45 and 60 minutes later
- Streptococcus mutans and Streptoccus sobrinus proliferation in dental biofilm ( PCR copies) will be analyzed at 0 and 120 minutes later
- The relative abundance of Streptococcus mutans and Streptococcus sobrinus in dental biofilm will be analyzed using Amplicon Sequence Variant at 0 and 120 minutes later
干预措施: Natural water (Other)
Sucrose
250 ml of natural water added with 25 of sucrose grams with should be drunk.
- Salivary pH will be analyzed at 0,5,10,15,30,45 and 60 minutes later
- Dental biofilm pH will be analyzed at 0,5,10,15,30,45 and 60 minutes later
- Streptococcus mutans and Streptoccus sobrinus proliferation in dental biofilm ( PCR copies) will be analyzed at 0 and 120 minutes later
- The relative abundance of Streptococcus mutans and Streptococcus sobrinus in dental biofilm will be analyzed using Amplicon Sequence Variant at 0 and 120 minutes later
干预措施: Stevioside (Drug)
Sucrose
250 ml of natural water added with 25 of sucrose grams with should be drunk.
- Salivary pH will be analyzed at 0,5,10,15,30,45 and 60 minutes later
- Dental biofilm pH will be analyzed at 0,5,10,15,30,45 and 60 minutes later
- Streptococcus mutans and Streptoccus sobrinus proliferation in dental biofilm ( PCR copies) will be analyzed at 0 and 120 minutes later
- The relative abundance of Streptococcus mutans and Streptococcus sobrinus in dental biofilm will be analyzed using Amplicon Sequence Variant at 0 and 120 minutes later
干预措施: Sucrose (Drug)
Sucrose
250 ml of natural water added with 25 of sucrose grams with should be drunk.
- Salivary pH will be analyzed at 0,5,10,15,30,45 and 60 minutes later
- Dental biofilm pH will be analyzed at 0,5,10,15,30,45 and 60 minutes later
- Streptococcus mutans and Streptoccus sobrinus proliferation in dental biofilm ( PCR copies) will be analyzed at 0 and 120 minutes later
- The relative abundance of Streptococcus mutans and Streptococcus sobrinus in dental biofilm will be analyzed using Amplicon Sequence Variant at 0 and 120 minutes later
干预措施: Natural water (Other)
结局指标
主要结局
Mean salivary pH with natural water
时间窗: 60 minutes
Logarithm of hydrogen ion concentration
Mean salivary pH with natural water added with 25 gr of sucrose
时间窗: 60 minutes
Logarithm of hydrogen ion concentration
Mean salivary pH with natural water added with 0.1 gr of stevioside
时间窗: 60 minutes
Logarithm of hydrogen ion concentration
次要结局
- Mean dental biofilm pH with natural water(60 minutes)
- Mean Mean dental biofilm pH with natural water added with 25 gr of sucrose(60 minutes)
- Mean dental biofilm pH with natural water added with 0.1 gr stevioside(60 minutes)
研究者
Guadalupe Barajas
Principal Investigator
Hospital Infantil de Mexico Federico Gomez