Assessment of Black Stains on Teeth in Relation to Salivary Parameters, Periodontal Health, and Body Mass Index in Children
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- DMFT index
研究概览
简要总结
Objective The aim of this study is to compare salivary flow rate, salivary pH, salivary buffering capacity, plaque index, gingival index, DMFT/dft indices, and body mass index (BMI) in systemically healthy children aged 5-10 years with and without black stains (BS) in the oral cavity. By evaluating the differences between these two groups, we seek to better understand the effects of black stains on oral health and assess the relationship between BMI and these parameters. The findings may contribute to improved oral health management, preventive dentistry practices, and a deeper understanding of the association between obesity and oral health in children.
Methods This study will consist of two groups of systemically healthy children: those with black stains (BS group, n=50) and those without (non-BS group, n=50). Both groups will be examined to determine the d (decayed), f (filled), and t (missing) values for primary teeth (dft index) and D (decayed), M (missing), and F (filled) values for permanent teeth (DMFT index).
We will assess plaque index and gingival index using Silness-Löe (1963, 1967) criteria. Saliva samples will be collected under standardized conditions (at least 2 hours post-breakfast, between 9-11 AM, after rinsing with water) in an isolated dental unit with patients seated upright.
Salivary pH will be measured using pH strips (GC Saliva-Check BUFFER) from unstimulated saliva. We will categorize pH levels as: highly acidic (5.0-5.8, red), moderately acidic (6.0-6.6, yellow), or healthy (6.8-7.8, green).
For salivary flow rate measurement, stimulated saliva will be collected after paraffin chewing (5 minutes) and measured in mL/min.
Salivary buffering capacity will be evaluated using GC Saliva-Check BUFFER test pads and scored as: very low (0-5), low (6-9), or normal/high (10-12).
We will calculate Body Mass Index (BMI) as kg/m² and interpret results using age- and sex-specific percentiles.
Statistical analysis will compare all parameters between the two groups.
详细描述
This study will compare salivary parameters (pH, flow rate, buffering capacity), plaque index, gingival index, DMFT/dft indices, and BMI between healthy children aged 5-10 years with (n=50) and without (n=50) black stains (BS). Saliva samples will be collected under standardized conditions, oral health parameters will be recorded through clinical examinations, and statistical analysis will assess differences between the two groups. The aim is to evaluate the impact of BS on oral health and its potential association with BMI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 5 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systemically healthy children (no chronic/acute systemic diseases)
- •No antibiotic therapy within the last 3 months
- •No use of medications affecting salivary flow (e.g., antihistamines, anticholinergics)
- •No application of any plaque-disclosing agents recently
- •Presence of clinically confirmed black stains on tooth surfaces
- •No professional dental cleaning in the past 3 months
- •No active caries lesions requiring immediate treatment
排除标准
- •Presence of any systemic disease (e.g., diabetes, autoimmune disorders)
- •Use of antibiotics or medications affecting salivary flow (e.g., antihistamines, antidepressants) in the last 3 months
- •History of professional dental cleaning or scaling in the past 3 months
- •Active dental caries requiring immediate treatment
- •Diagnosed salivary gland disorders or xerostomia (chronic dry mouth)
研究组 & 干预措施
Black stain-positive
The study group was named 'black stain-positive'
干预措施: Study Group:Black stain-positive (Other)
Black stain-negative
The control group was named 'black stain-negative'
干预措施: Control Group: Black stain-negative (Other)
结局指标
主要结局
DMFT index
时间窗: 2 months
To determine the DMFT index score, decayed teeth in permanent teeth are indicated as "D", lost teeth extracted due to decay are indicated as "M", and filled teeth are indicated as "F". The DMFT index is calculated by adding the D, M, F values and dividing them by the total number of permanent teeth. An increase in the calculated scores indicates that oral and dental health is negatively affected.
dft index
时间窗: 2 months
The dft Index is the calculated form of the DMFT index for primary teeth. When calculating the dft group index, missing teeth are not included in the calculation. Because it is difficult to diagnose the reason for the loss of primary teeth and there is a high probability of error. For this reason, the number of decayed and filled teeth is calculated during the examination. Decayed teeth are indicated with "d" and filled teeth with "f". The dft index is calculated by adding the d and f values and dividing them by the total number of permanent teeth. An increase in the calculated scores indicates that oral and dental health is negatively affected
Saliva pH
时间窗: 2 months
Salivary pH was measured using pH indicator strips. A low pH (\<6.5) indicates an acidic environment and increases the risk of tooth demineralization and caries, whereas a high pH (\>7.5) indicates an alkaline state, which may be linked to decreased bacterial activity but may also indicate systemic conditions.
Unstimulated salivary flow rate
时间窗: 2 months
Unstimulated salivary flow rate is measured by collecting unstimulated saliva over a period of time and calculating the volume per minute. A low flow rate (\<0.1 mL/min) indicates hyposalivation, which increases the risk of caries and oral infection, while a high flow rate may be associated with conditions such as gastroesophageal reflux or medication effects.
Saliva buffering capacity
时间窗: 2 months
Saliva buffering capacity was measured using the GC Saliva Buffer Kit, which uses a scoring system based on color changes. A low buffering capacity indicates a higher risk of dental caries and enamel demineralization, whereas a high buffering capacity indicates better protection against acid attacks in the oral environment.
PIaque index (PI)
时间窗: 2 months
Based on Silness-Löe (1963, 1967) PI values, bacterial plaque and plaque thickness in direct contact with the marginal gingiva are evaluated. The evaluation is made with the Williams-marked University of Michigan 'O' periodontal probe, and PI values are recorded from a total of 4 surfaces of each tooth included in the study, namely mesial, distal, buccal and lingual. The averages of these values are calculated for each patient. The average scores obtained are evaluated in the 0-3 score range. An increase in the calculated scores indicates that periodontal health is negatively affected.
Gingival index (GI)
时间窗: 2 months
The degree of gingivitis is assessed using the Silness-Löe (1963, 1967) GI. The average of the measurements taken from four sides of the tooth determines the GI score of the tooth, and the average of the measurements of all teeth determines the individual's gingival index score. The scores obtained are evaluated in the range of 0-3. An increase in the calculated scores indicates that periodontal health is negatively affected.
Body Mass Index (BMI)
时间窗: 2 months
BMI is calculated by dividing weight (in kilograms) by the square of height (in meters) (kg/m²). In children, unlike adults, BMI is evaluated using age- and sex-specific percentile curves. An increase in BMI indicates a higher risk of obesity, which is associated with cardiovascular diseases, diabetes, and oral health problems such as periodontal disease and caries. A decrease in BMI may suggest undernutrition or growth retardation, potentially affecting immune function and dental development.
Percentile
时间窗: 2 months
Percentile is a statistical measure that indicates a child's BMI relative to other children of the same age and sex. It is determined using WHO (World Health Organization) or CDC growth charts.A high percentile (≥85th) indicates that the child is heavier than peers, increasing the risk of obesity and metabolic complications. A low percentile (\<5th) suggests growth retardation or malnutrition risk, which may manifest as oral mucosal lesions or delayed tooth development.
次要结局
未报告次要终点
研究者
Ozge Gungor
pHd, DDS, Assoc. Prof. Dr.
Akdeniz University