Black StainsNCT06985446
Assessment of Black Stains on Teeth in Relation to Salivary Parameters, Periodontal Health, and Body Mass Index in Children
A study testing Study Group:Black stain-positive in people with Black Stains, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Black Stains
- What is being tested?
- Study Group:Black stain-positive
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 May 2025to 15 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Akdeniz University Faculty of Dentistry, Department of Pediatric Dentistry
Antalya, Konyaaltı
About this study
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).
Read more
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.
Read the 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
- Being tested
- Study Group:Black stain-positive, Control Group: Black stain-negative
- Keywords
- Salivary biomarkers, Child dental health, Body Mass Index (BMI), Oral health indices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study Group:Black stain-positiveOther
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).
Control Group: Black stain-negativeOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Black stain-positive | Experimental | The study group was named 'black stain-positive' Receives: Other: Study Group:Black stain-positive |
| Black stain-negative | Experimental | The control group was named 'black stain-negative' Receives: Other: Control Group: Black stain-negative |
What is being measured
The primary outcome is the main question the study is designed to answer.
DMFT index
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.
Measured: 2 months
dft index
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
Measured: 2 months
Saliva pH
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.
Measured: 2 months
Unstimulated salivary flow rate
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.
Measured: 2 months
Saliva buffering capacity
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.
Measured: 2 months
PIaque index (PI)
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.
Measured: 2 months
Gingival index (GI)
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.
Measured: 2 months
Body Mass Index (BMI)
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.
Measured: 2 months
Percentile
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start14 May 2025
- Primary completion5 Dec 2025
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Black StainsStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozge Gungor, Akdeniz University
- Investigators
- İrem Kapıcı, Research Assistant, Principal investigator, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06985446
- Sponsor's protocol ID
- AkdenizUıremkapıcı003
- Status last verified
- Oct 2026
- First submitted
- 15 May 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Black Stains on Teeth in Relation to Salivary Parameters, Periodontal Health, and Body Mass Index in Children
- ClinicalTrials.gov ID
- NCT06985446
- Acronym / sponsor ID
- AkdenizUıremkapıcı003
- Conditions
- Black Stains
- Keywords
- Salivary biomarkers, Child dental health, Body Mass Index (BMI), Oral health indices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 14 May 2025 (actual)
- Primary completion
- 5 Dec 2025 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 22 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Black stain-positive | Experimental | Other: Study Group:Black stain-positiveThe study group was named 'black stain-positive' |
| Black stain-negative | Experimental | Other: Control Group: Black stain-negativeThe control group was named 'black stain-negative' |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study Group:Black stain-positiveIn 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 | Black stain-positive |
| Control Group: Black stain-negativeIn 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). | Other | Black stain-negative |
Primary outcome
DMFT index
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
İrem Kapıcı, Research Assistant principal investigator
Akdeniz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study Group:Black stain-positive in people with Black Stains, run by Akdeniz University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DMFT index (time frame: 2 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.