NCT06985446

Assessment of Black Stains on Teeth in Relation to Salivary Parameters, Periodontal Health, and Body Mass Index in Children

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Akdeniz University · Academic / Other
• Sex: All
• Age: 5 Years – 10 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Black Stains

Interventions

Type	Name	Description
OTHER	Study Group:Black stain-positive	In children with black stains (BS+), we evaluated DMFT, dft, plaque index (Silness-Löe), gingival index (Löe-Silness), salivary pH, salivary flow rate, salivary buffering capacity, and body mass index (BMI).
OTHER	Control Group: Black stain-negative	In healthy children without black stains (BS-), we assessed DMFT, dft, plaque index (Silness-Löe), gingival index (Löe-Silness), salivary pH, salivary flow rate, salivary buffering capacity, and body mass index (BMI).

Timeline

• Start date: 2025-05-14
• Primary completion: 2025-06-05
• Completion: 2025-07-31
• First posted: 2025-05-22
• Last updated: 2025-06-03

Locations

1 site across 1 country: Turkey (Türkiye)