Clinical trial NCT06985446: Assessment of Black Stains on Teeth in Relation to Salivary Parameters, Periodontal Health, and Body Mass Index in Children
Official title: Assessment of Black Stains on Teeth in Relation to Salivary Parameters, Periodontal Health, and Body Mass Index in Children
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Black Stains
Keywords: Salivary biomarkers
Child dental health
Body Mass Index (BMI)
Oral health indices
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

Eligibility criteria: 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)

Primary outcomes:
measure: DMFT index
timeFrame: 2 months
measure: dft index
timeFrame: 2 months
measure: Saliva pH
timeFrame: 2 months
measure: Unstimulated salivary flow rate
timeFrame: 2 months
measure: Saliva buffering capacity
timeFrame: 2 months
measure: PIaque index (PI)
timeFrame: 2 months
measure: Gingival index (GI)
timeFrame: 2 months
measure: Body Mass Index (BMI)
timeFrame: 2 months
measure: Percentile
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Akdeniz University Faculty of Dentistry, Department of Pediatric Dentistry
state: Konyaaltı
Study officials:
affiliation: Akdeniz University
name: İrem Kapıcı, Research Assistant
role: PRINCIPAL_INVESTIGATOR
References: