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

Akdeniz University

Status

Active, not recruiting

Conditions

Black Stains

Treatments

Other: Control Group: Black stain-negative

Other: Study Group:Black stain-positive

Study type

Interventional

Funder types

Other

Identifiers

NCT06985446

AkdenizUıremkapıcı003

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

5 to 10 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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)