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

NCT06985446 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-06-03

No results posted yet for this study

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.

Conditions

  • Black Stains

Interventions

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).

Sponsors & Collaborators

  • Akdeniz University

    lead OTHER

Principal Investigators

  • İrem Kapıcı, Research Assistant · Akdeniz University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-14
Primary Completion
2025-06-05
Completion
2025-07-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06985446 on ClinicalTrials.gov