Dental Caries in ChildrenNCT04001959
Potential for Dentine Discoloration of Silver Diamino Fluoride Associated With Potassium Iodide
A study testing Silver Diamine Fluoride with Potassium Iodide in people with Dental Caries in Children, run by Federal University of the Valleys of Jequitinhonha and Mucuri at 1 site in Brazil.
Trial summary
The objective of this randomized clinical trial will be the comparison of dentine discoloration after treatment with: Silver Diamino Fluoride and Silver Diamino Fluoride associated with Potassium Iodide for caries lesions in posterior primary teeth. Read more about this study
- Who is it for?
- Ages 1 year to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries in Children
- What is being tested?
- Silver Diamine Fluoride with Potassium Iodide
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 2 May 2019to Sep 2019
- 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 1 year to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children who have at least one vital deciduous tooth with a dentin cavitated lesion.
- Children whose parents / guardians agree to their child's participation in the study.
Who cannot join
- Child with systemic health impairment;
- Child who has already performed dental treatment on the tooth to be included in the research;
- Sensitivity to chemicals used;
- Tooth with spontaneous pain;
- Tooth with pulp wrapping;
- Radiographic evidence of pathological internal or external resorption of the root;
- Radiographic evidence of periapical lesion;
Trial locations and contacts
1 site in 1 country.
Marcos L Pinheiro, PhD contact
Brazil1 site, 1 recruiting
- Recruiting
Priscila Seixas Mourão
Diamantina, Minas Gerais, 39.100-00
Priscila S Mourão, Graduated, +5538998262283, priscila.smourao@gmail.com
About this study
Official title: Comparison of the Potential for Dentine Discoloration of Silver Diamino Fluoride and Silver Diamino Fluoride Associated With Potassium Iodide
The objective of this randomized clinical trial will be the comparison of dentine discoloration after treatment with: Silver Diamino Fluoride and Silver Diamino Fluoride associated with Potassium Iodide for caries lesions in posterior primary teeth. The study sample will consist of children presenting caries lesion in dentin, without reporting spontaneous pain. The children will be allocated into 2 groups that will correspond to the treatments with the use of SDF (Group 1), SDF + PI (Group 2). Treatment will be performed by trained and calibrated researchers. Examiners will be blind to the treatment received. Initially, data will be collected on socio-demographic aspects, characteristics of children, and clinical aspects. Clinical, photographic and initial evaluations will be performed after 1 week, 15 days, 1 and 2 months after treatment. The results obtained will be typed and organized in a database, using the software Statistical Package for Social Science (SPSS), version 22.0 and descriptive, bivariate analyzes will be performed.
Read the detailed description
Primary Objective:
To compare dentine discoloration in caries lesions in the deciduous dentition after Silver Diamino Fluoride treatment with and without association with Potassium Iodide (PI).
Secondary Objective:
To compare the effectiveness of the methods in the inactivation of active carious lesions Compare the inactivation time of the lesions between the groups Compare the presence of biofilm accumulation in the different comparing the differences in the effectiveness of the methods for inactivation of lesions on different surfaces.
Scratchs:
The risks inherent to the study are related to the embarrassment at the moment of answering the questionnaires, however they will be carried out in a reserved space. There is a risk of discomfort for the child or the caretaker during the evaluation and / or clinical examination. However, the examiners will be prepared to identify any possible discomfort and discontinue the evaluation if this occurs. The risks may also be related to the identification of the participants, however the medical record with questionnaires will only be accessed by the research team. There are also clinical risks inherent in the progression of caries, in which case the team will perform conventional and indicated the current clinical situation (restoration, endodontics, dental extraction). The research will be immediately suspended if there is suspicion of any risk or damage to the health of the participant.
Benefits:
The benefits relate to remission of signs and symptoms after treatment. In addition, there will be maintenance of the dental elements in the oral cavity of the child until its physiological exfoliation, thus avoiding the damages resulting from the early loss of a deciduous tooth such as: reduction in mastication and phonetic efficiency, loss of vertical dimension, impairment of aesthetics , installation of deleterious oral habits, impairment of craniofacial development, damage to the permanent dentition, and intense psychological repercussions.
Proposed Methodology:
Ten children will be examined by the examiner and an experienced investigator in order to obtain inter-examiner agreement. The sequence of procedures to be performed in the participants during the study will be: 1st Consultation: Application of the sociodemographic, general health of the child and habits questionnaire; biofilm evaluation; Clinical evaluation of the caries (ICDAS + AAL); Photograph of the lesion; Behavioral evaluation of the child; Application of treatment (Randomization). 2nd Consultation (1 week): Photography; Pain evaluation (DDQ-B), behavioral evaluation. 3rd Consultation (15 days): Photography; Treatment follow-up; Pain evaluation (DDQ-B); Behavioral evaluation of the child.4ª Consultation (1 month): Photography; Biofilm evaluation; Treatment follow-up; Pain evaluation (DDQ-B); Behavioral evaluation of the child. 5th Consultation (2 months): Photography; Biofilm evaluation; treatment follow-up; Pain evaluation (DDQ-B); Clinical evaluation of caries lesion (ICDAS + AAL); Behavioral assessment of the child. Children of the study, their parents and the examiner will remain blind to the allocation of the children's group. Blinding of the operator will not be possible, since the technique of use allows the identification of the material used.
Data Analysis Methodology:
The results obtained will be typed and organized in a database, using the software Statistical Package for Social Science (SPSS), version 22.0. Initially, a description of the absolute and relative frequencies will be performed, as well as the measures of central tendency of the variables studied. In addition, the distribution of the data will be verified in order to evaluate if the data present normality, which will guide the choice by the use of parametric or non-parametric tests. Bivariate analysis will be performed to verify the association between the dependent variables and the type of treatment. The categorical variables will be evaluated using Fisher's Qui-square and Exact tests. For the quantitative variables, the study of the distribution of the data will initially be performed. If these present a normal distribution, the Anova parametric tests and paired T-test will be used. If the distribution is not normal, the Friedman and Wilcoxon tests will be used. The null hypothesis is that there is no association between the variables (p> 0.05).
- Conditions
- Dental Caries in Children
- Being tested
- Silver Diamine Fluoride with Potassium Iodide
- Keywords
- Carostats, Clinical trial, Preventive dentistry, Preschoolers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silver Diamine Fluoride with Potassium IodideProcedure or surgery
Dry the tooth for 30 seconds with air jet and apply one drop of Diamino 30% Silver Fluoride with a disposable applicator brush for 3 minutes and one drop of potassium iodide solution immediately on the treated surface, then wash.
| Study group | Role | What they receive |
|---|---|---|
| Silver Diamine Fluoride | Active comparator | Initially a prophylaxis will be done on the tooth to be treated with Robinson brush and prophylactic paste and then the relative isolation (with mouth openers and cotton rollers) and protection of the soft tissues with vaseline in the region to be treated to protect the surrounding tissues will be carried out. Next, dry the tooth for 30 seconds with air jet followed by a drop of 30% Diamino Fluoride Silver with a disposable applicator brush for 3 minutes and after that time washing for 1 minute. Receives: Procedure: Silver Diamine Fluoride with Potassium Iodide |
| Silver Diamine Fluoride with Potassium Iodide | Experimental | Initially a prophylaxis will be done on the tooth to be treated with Robinson brush and prophylactic paste and then the relative isolation (with mouth openers and cotton rollers) and protection of the soft tissues with vaseline in the region to be treated to protect the surrounding tissues will be carried out. Then the tooth is dried for 30 seconds with an air jet and applied one drop of the Diamino 30% Silver Fluoride with a disposable applicator brush for 3 minutes and one drop of potassium iodide solution immediately on the surface treated with Diamino , until the formed creamy white color becomes transparent. After these steps have been completed, rinse with water for 1 minute. Receives: Procedure: Silver Diamine Fluoride with Potassium Iodide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dentin color change
In all the consultations will be made photographic shoots of the tooth with purpose of comparison. Then all images will be downloaded to the computer and analyzed using the Windows program - Paint. The tooth will be analyzed on all its faces. The coloration will be evaluated in scores from 0 to 4 where 0 is white, 1 yellow, 2 light brown, 3 dark brown and 4 black.
Measured: 1 week, 15 days, 1 and 2 months
Secondary outcomes (2)
Clinical success based on the International System for Assessment and Detection of Caries (ICDAS)
The ICDAS describes six stages of dental caries extension, ranging from initial visible changes in the enamel to the sharp dentin cavitation. We will use this index to evaluate the stoppage and prevention of caries by the proposed treatment.
Measured: 1 and 2 months
Parental Satisfaction Scale
Satisfaction with the type of treatment proposed. Scale ranging from 0 to 10, where 0 is the worst condition and 10 is the best condition.
Measured: 1 and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study start2 May 2019
- Primary completionJul 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Caries in ChildrenStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, controlled study in which the variables were evaluated 1 week, 15 days, 1 and 2 months after the intervention. For the allocation of participants, a Randomization ratio of 1: 1 was performed.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of the Valleys of Jequitinhonha and Mucuri
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04001959
- Sponsor's protocol ID
- 04243718.0.0000.5108
- Status last verified
- Jul 2019
- First submitted
- 24 Jun 2019
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Potential for Dentine Discoloration of Silver Diamino Fluoride and Silver Diamino Fluoride Associated With Potassium Iodide
- ClinicalTrials.gov ID
- NCT04001959
- Acronym / sponsor ID
- 04243718.0.0000.5108
- Conditions
- Dental Caries in Children
- Keywords
- Carostats, Clinical trial, Preventive dentistry, Preschoolers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Federal University of the Valleys of Jequitinhonha and MucuriUniversity, hospital or other
- Study start
- 2 May 2019 (actual)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 28 Jun 2019 (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.
The objective of this randomized clinical trial will be the comparison of dentine discoloration after treatment with: Silver Diamino Fluoride and Silver Diamino Fluoride associated with Potassium Iodide for caries lesions in posterior primary teeth. The study sample will consist of children presenting caries lesion in dentin, without reporting spontaneous pain. The children will be allocated into 2 groups that will correspond to the treatments with the use of SDF (Group 1), SDF + PI (Group 2). Treatment will be performed by trained and calibrated researchers. Examiners will be blind to the treatment received. Initially, data will be collected on socio-demographic aspects, characteristics of children, and clinical aspects. Clinical, photographic and initial evaluations will be performed after 1 week, 15 days, 1 and 2 months after treatment. The results obtained will be typed and organized in a database, using the software Statistical Package for Social Science (SPSS), version 22.0 and descriptive, bivariate analyzes will be performed.
Detailed description
Primary Objective:
To compare dentine discoloration in caries lesions in the deciduous dentition after Silver Diamino Fluoride treatment with and without association with Potassium Iodide (PI).
Secondary Objective:
To compare the effectiveness of the methods in the inactivation of active carious lesions Compare the inactivation time of the lesions between the groups Compare the presence of biofilm accumulation in the different comparing the differences in the effectiveness of the methods for inactivation of lesions on different surfaces.
Scratchs:
The risks inherent to the study are related to the embarrassment at the moment of answering the questionnaires, however they will be carried out in a reserved space. There is a risk of discomfort for the child or the caretaker during the evaluation and / or clinical examination. However, the examiners will be prepared to identify any possible discomfort and discontinue the evaluation if this occurs. The risks may also be related to the identification of the participants, however the medical record with questionnaires will only be accessed by the research team. There are also clinical risks inherent in the progression of caries, in which case the team will perform conventional and indicated the current clinical situation (restoration, endodontics, dental extraction). The research will be immediately suspended if there is suspicion of any risk or damage to the health of the participant.
Benefits:
The benefits relate to remission of signs and symptoms after treatment. In addition, there will be maintenance of the dental elements in the oral cavity of the child until its physiological exfoliation, thus avoiding the damages resulting from the early loss of a deciduous tooth such as: reduction in mastication and phonetic efficiency, loss of vertical dimension, impairment of aesthetics , installation of deleterious oral habits, impairment of craniofacial development, damage to the permanent dentition, and intense psychological repercussions.
Proposed Methodology:
Ten children will be examined by the examiner and an experienced investigator in order to obtain inter-examiner agreement. The sequence of procedures to be performed in the participants during the study will be: 1st Consultation: Application of the sociodemographic, general health of the child and habits questionnaire; biofilm evaluation; Clinical evaluation of the caries (ICDAS + AAL); Photograph of the lesion; Behavioral evaluation of the child; Application of treatment (Randomization). 2nd Consultation (1 week): Photography; Pain evaluation (DDQ-B), behavioral evaluation. 3rd Consultation (15 days): Photography; Treatment follow-up; Pain evaluation (DDQ-B); Behavioral evaluation of the child.4ª Consultation (1 month): Photography; Biofilm evaluation; Treatment follow-up; Pain evaluation (DDQ-B); Behavioral evaluation of the child. 5th Consultation (2 months): Photography; Biofilm evaluation; treatment follow-up; Pain evaluation (DDQ-B); Clinical evaluation of caries lesion (ICDAS + AAL); Behavioral assessment of the child. Children of the study, their parents and the examiner will remain blind to the allocation of the children's group. Blinding of the operator will not be possible, since the technique of use allows the identification of the material used.
Data Analysis Methodology:
The results obtained will be typed and organized in a database, using the software Statistical Package for Social Science (SPSS), version 22.0. Initially, a description of the absolute and relative frequencies will be performed, as well as the measures of central tendency of the variables studied. In addition, the distribution of the data will be verified in order to evaluate if the data present normality, which will guide the choice by the use of parametric or non-parametric tests. Bivariate analysis will be performed to verify the association between the dependent variables and the type of treatment. The categorical variables will be evaluated using Fisher's Qui-square and Exact tests. For the quantitative variables, the study of the distribution of the data will initially be performed. If these present a normal distribution, the Anova parametric tests and paired T-test will be used. If the distribution is not normal, the Friedman and Wilcoxon tests will be used. The null hypothesis is that there is no association between the variables (p> 0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- A randomized, controlled study in which the variables were evaluated 1 week, 15 days, 1 and 2 months after the intervention. For the allocation of participants, a Randomization ratio of 1: 1 was performed.
| Arm | Type | Receives |
|---|---|---|
| Silver Diamine Fluoride | Active comparator | Procedure: Silver Diamine Fluoride with Potassium IodideInitially a prophylaxis will be done on the tooth to be treated with Robinson brush and prophylactic paste and then the relative isolation (with mouth openers and cotton rollers) and protection of the soft tissues with vaseline in the region to be treated to protect the surrounding tissues will be carried out. Next, dry the tooth for 30 seconds with air jet followed by a drop of 30% Diamino Fluoride Silver with a disposable applicator brush for 3 minutes and after that time washing for 1 minute. |
| Silver Diamine Fluoride with Potassium Iodide | Experimental | Procedure: Silver Diamine Fluoride with Potassium IodideInitially a prophylaxis will be done on the tooth to be treated with Robinson brush and prophylactic paste and then the relative isolation (with mouth openers and cotton rollers) and protection of the soft tissues with vaseline in the region to be treated to protect the surrounding tissues will be carried out. Then the tooth is dried for 30 seconds with an air jet and applied one drop of the Diamino 30% Silver Fluoride with a disposable applicator brush for 3 minutes and one drop of potassium iodide solution immediately on the surface treated with Diamino , until the formed creamy white color becomes transparent. After these steps have been completed, rinse with water for 1 minute. |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children who have at least one vital deciduous tooth with a dentin cavitated lesion.
- Children whose parents / guardians agree to their child's participation in the study.
Key exclusion criteria (7 listed)
- Child with systemic health impairment;
- Child who has already performed dental treatment on the tooth to be included in the research;
- Sensitivity to chemicals used;
- Tooth with spontaneous pain;
- Tooth with pulp wrapping;
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 |
|---|---|---|
| Silver Diamine Fluoride with Potassium IodideDry the tooth for 30 seconds with air jet and apply one drop of Diamino 30% Silver Fluoride with a disposable applicator brush for 3 minutes and one drop of potassium iodide solution immediately on the treated surface, then wash. | Procedure or surgery | Silver Diamine Fluoride, Silver Diamine Fluoride with Potassium Iodide |
Primary outcome
Dentin color change
Time frame: 1 week, 15 days, 1 and 2 months
In all the consultations will be made photographic shoots of the tooth with purpose of comparison. Then all images will be downloaded to the computer and analyzed using the Windows program - Paint. The tooth will be analyzed on all its faces. The coloration will be evaluated in scores from 0 to 4 where 0 is white, 1 yellow, 2 light brown, 3 dark brown and 4 black.
2 secondary outcomes
Clinical success based on the International System for Assessment and Detection of Caries (ICDAS)
Time frame: 1 and 2 months
Parental Satisfaction Scale
Time frame: 1 and 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- 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.
Marcos L Pinheiro, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silver Diamine Fluoride with Potassium Iodide in people with Dental Caries in Children, run by Federal University of the Valleys of Jequitinhonha and Mucuri at 1 site in Brazil.
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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 5 Jul 2019. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Priscila S Mourão, Graduated (+5538998262283, priscila.smourao@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dentin color change (time frame: 1 week, 15 days, 1 and 2 months). 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 5 Jul 2019.