Dental CariesNCT05008718
Silver Diamine Fluoride: A Randomized Controlled Trial on Its Effectiveness As A Caries Arresting Agent
A study testing 38% SDF group and 5% NaF group in people with Dental Caries and Quality of Life, run by Universiti Teknologi Mara at 1 site in Malaysia.
Trial summary
The aim of the study is to assess the effectiveness of 38% Silver Diamine Fluoride (SDF) solution and to determine if it is superior to 5% NaF varnish in arresting carious lesions in the primary teeth of young children attending general dental clinic, Universiti Teknologi Mara. Read more about this study
- Who is it for?
- Ages 3 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Quality of Life
- What is being tested?
- 38% SDF group and 5% NaF group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 1 siteMalaysia
- Study dates
- 21 Jun 2022to Feb 2024
- 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 3 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Three to eight years old children. The reason for selecting children up to eight years old is because there are still patients aged seven to eight years old who presented with posterior deciduous teeth and upper lateral incisor deciduous teeth caries. Children below three years old are not included in order to obtain better cooperation from the participants.
- Children who are generally healthy, not medically compromised
- Children who have at least one active carious lesion on a deciduous tooth which include upper anterior teeth caries (c-c) with a minimum score of 05 as defined by the International Caries Detection and Assessment System (ICDAS)
- Provision of informed consent by the parent or guardian
Who cannot join
- Children with spontaneous or elicited pain from caries, tooth mobility, or signs of pulpal infection
- Children with severe medical conditions that would not allow management in the clinic
- Children with hereditary developmental defects, such as amelogenesis imperfecta
- Children with known allergies or sensitivities to dental materials, including silver diamine fluoride and sodium fluoride
- Inability to cooperate for silver diamine fluoride treatment or return for recall visits 3 months
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Faculty of Dentistry, Universiti Teknologi Mara, Sg. Buloh Campus
Sungai Buloh, Selangor, 47000
About this study
The aim of the study is to assess the effectiveness of 38% Silver Diamine Fluoride (SDF) solution and to determine if it is superior to 5% NaF varnish in arresting carious lesions in the primary teeth of young children attending general dental clinic, Universiti Teknologi Mara.
Hypothesis: Topical application of a 38% SDF solution on the primary teeth is superior to that of a 5% NaF varnish in arresting caries lesions in children at 3-months follow-up
An intervention study is planned to compare the effectiveness of 38% SDF and 5% NaF in arresting caries lesions in primary teeth of 3-8 years old children attending general dental clinic, Universiti Teknologi Mara. The sample size needed (considering a 20% dropout rate) is 66 participants in each group. In addition, this study also aims to determine the demographic background, oral health-related habits, oral health-related quality of life of the participants and the parents acceptance on SDF treatment towards their child.
Read the detailed description
Convenience sampling will be used, in which patient will be recruited from General Dental Clinic (Sapphire), Faculty of Dentistry, Universiti Teknologi Mara. The total number of participants needed is 132. At baseline, during the screening and examination stage, apart from ICDAS score and the decayed, missing, and filled surface (dmfs) index to record each child's caries experience, recorded status will also include baseline bitewings of posterior teeth and DIAGNOdent reading (triplicate reading will be carried out to achieve accurate value) for all lesions. Periapical radiograph of anterior teeth will only be taken to confirm no pulp involvement when depth of lesion is questionable. Five tooth surfaces (buccal, lingual, mesial, distal and occlusal) will be examined in each posterior tooth and four tooth surfaces (labial, lingual, mesial and distal) in each anterior tooth. A carious lesion will be recorded as active if softness is detected upon gentle probing. If the lesion is hard when probing, it will be classified as an arrested caries. Screening and oral examination will be conducted on a dental chair in assigned clinic at Faculty of Dentistry, Universiti Teknologi Mara, primarily through careful visual inspection with the aid of a World Health Organization (WHO) CPI probe and a stainless steel/disposable front surface dental mirror by the main researcher. The main researcher will record each patient's caries status on a separate paper-based trial record at the beginning of the study in which she will not have the access to Integrated Dental Record Management System (IDERMS) in order to maintain blindness. Before conducting the study, a training and calibration session for oral examination (ICDAS and DIAGnodent utilization) is planned for the main researcher with one specialist in dental public health and one specialist in paediatric dentistry with the aim to achieve the kappa values of inter and intra-reliability ≥0.8.
Next, after the screening and before consent, if the child is eligible for the study, parents or guardians will be provided with information about SDF and NaF, follow-up instructions, oral hygiene instruction and diet education which will use video and pamphlet. Parents and guardians who agreed to participate in the study will be given questionnaire which include children's demographic background, oral-health related habits, and Malay- ECOHIS together with the information sheet and consent sheet. Appointment for first topical fluoride application will be given within one week from baseline oral examination day.
On the first appointment day, the allocation of patient between 38% SDF application and 5 % NaF application is randomized using sequentially numbered, opaque sealed envelopes (SNOSE) procedure (Doig \& Simpson, 2005). Block of four and six will be used to ensure that similar numbers of patients are enrolled into each group and to ensure the prediction of allocation sequence impossible. The order of the blocks will be determined by flipping a coin. This will be carried out by a dental officer/postgraduate student who is not involved with the study. He/she will keep the piles of blocks and when participant comes for the intervention, he/she will ask the operator to select one envelope from the first pile of blocks according to allocated sequence and will prepare the treatment selected. After first application is completed, he/she also will be the one who will update the Integrated Dental Record Management System (IDERMS) on which treatment has been used for the respective participants in order for him/her to prepare the same treatment for the 1-month follow up. The topical fluoride applications will be carried out by the other three researchers who are not involved in the screening and assessing of the lesion activity. Before the study, they will be trained by a paediatric dental specialist who is not involved in the study for the clinical application procedure. This is a double-blind clinical trial where the main researcher is not aware of which treatment the participants will be receiving, the other researchers are not aware which treatment they are providing and participants are not aware of which treatment they are receiving.
Participants will be called again for second application of same treatment they received on the first appointment after one month. Final appointment follow-up examination will be given at three months after first application of the topical fluoride. Same examiner will conduct the follow-up oral examinations using the same equipment, procedure and diagnostic criteria as those used in the baseline examination. Another questionnaire inclusive of parental acceptability for SDF treatment on their children and OHRQoL (Malay-ECOHIS) will be distributed to the same parents or guardians and will be asked to complete the questionnaire survey. After study is completed, the participants will be assigned back to undergraduate students for definitive treatment.
- Conditions
- Dental Caries, Quality of Life
- Being tested
- 38% SDF group, 5% NaF group
- Keywords
- silver diamine fluoride, dental caries, effectiveness
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
38% SDF groupOther
Participants will be randomized and will receive either 38% SDF treatment or 5% NaF treatment
5% NaF groupOther
Participants will be randomized and will receive either 38% SDF treatment or 5% NaF treatment
| Study group | Role | What they receive |
|---|---|---|
| 38% SDF group | Active comparator | 38% silver diamine fluoride will be applied on caries lesions on deciduous teeth with a minimum score of 05 as defined by the International Caries Detection and Assessment System (ICDAS) Receives: Other: 38% SDF group |
| 5% NaF group | Placebo comparator | 5% sodium fluoride will be applied on caries lesions on deciduous teeth with a minimum score of 05 as defined by the International Caries Detection and Assessment System (ICDAS) Receives: Other: 5% NaF group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caries arrest rate
After SDF or NaF application, after 3 months assessment, smooth and hard tooth surface that could not be penetrated by probe easily will be classified as arrested lesion. Caries arrest rate will be calculated by the percentage of all arrested lesions over all treatment applied teeth in respective arm.
DIAGNOdent reading will be taken for all lesions before and after treatment in which DIAGNOdent reading ≥ 16 is indicated more likely to develop dentin caries after 24 mos.
Measured: 3 months
Secondary outcomes (1)
Oral Health-Related Quality of Life
Participants' oral health-related quality of life will be assessed using ECOHIS (Early Childhood Oral Health Impact Scale) that has been translated and validated in Malay language. Parents will be given the questionnaire and will be asked to complete it before and after intervention.
The Malay-ECOHIS consists of 13 items with two main parts: the child impacts section (CIS) which has 4 domains with 9 items and the family impacts section (FIS) which has 2 domains with 4 items. The total of Malay-ECOHIS scores and scores for individual domains will be calculated as a simple sum of the response codes. Higher scores will indicate greater degrees of oral impact on the quality of life of the child.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start21 Jun 2022
- Primary completion10 Feb 2023
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Teknologi Mara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Intan Elliayana Binti Mohammed, Universiti Teknologi Mara
- Investigators
- Intan Elliayana binti Mohammed, Principal investigator, Faculty of Dentistry, Universiti Teknologi Mara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05008718
- Sponsor's protocol ID
- SDF_UiTM
- Status last verified
- Nov 2023
- First submitted
- 14 Aug 2021
- Last updated
- 18 Nov 2023
- Results posted
- 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 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Silver Diamine Fluoride: A Randomized Controlled Trial on Its Effectiveness As A Caries Arresting Agent
- ClinicalTrials.gov ID
- NCT05008718
- Acronym / sponsor ID
- SDF_UiTM
- Conditions
- Dental Caries, Quality of Life
- Keywords
- silver diamine fluoride, dental caries, effectiveness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Universiti Teknologi MaraUniversity, hospital or other
- Study start
- 21 Jun 2022 (actual)
- Primary completion
- 10 Feb 2023 (actual)
- Study completion
- Feb 2024 (estimated)
- First posted
- 17 Aug 2021 (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 aim of the study is to assess the effectiveness of 38% Silver Diamine Fluoride (SDF) solution and to determine if it is superior to 5% NaF varnish in arresting carious lesions in the primary teeth of young children attending general dental clinic, Universiti Teknologi Mara.
Hypothesis: Topical application of a 38% SDF solution on the primary teeth is superior to that of a 5% NaF varnish in arresting caries lesions in children at 3-months follow-up
An intervention study is planned to compare the effectiveness of 38% SDF and 5% NaF in arresting caries lesions in primary teeth of 3-8 years old children attending general dental clinic, Universiti Teknologi Mara. The sample size needed (considering a 20% dropout rate) is 66 participants in each group. In addition, this study also aims to determine the demographic background, oral health-related habits, oral health-related quality of life of the participants and the parents acceptance on SDF treatment towards their child.
Detailed description
Convenience sampling will be used, in which patient will be recruited from General Dental Clinic (Sapphire), Faculty of Dentistry, Universiti Teknologi Mara. The total number of participants needed is 132. At baseline, during the screening and examination stage, apart from ICDAS score and the decayed, missing, and filled surface (dmfs) index to record each child's caries experience, recorded status will also include baseline bitewings of posterior teeth and DIAGNOdent reading (triplicate reading will be carried out to achieve accurate value) for all lesions. Periapical radiograph of anterior teeth will only be taken to confirm no pulp involvement when depth of lesion is questionable. Five tooth surfaces (buccal, lingual, mesial, distal and occlusal) will be examined in each posterior tooth and four tooth surfaces (labial, lingual, mesial and distal) in each anterior tooth. A carious lesion will be recorded as active if softness is detected upon gentle probing. If the lesion is hard when probing, it will be classified as an arrested caries. Screening and oral examination will be conducted on a dental chair in assigned clinic at Faculty of Dentistry, Universiti Teknologi Mara, primarily through careful visual inspection with the aid of a World Health Organization (WHO) CPI probe and a stainless steel/disposable front surface dental mirror by the main researcher. The main researcher will record each patient's caries status on a separate paper-based trial record at the beginning of the study in which she will not have the access to Integrated Dental Record Management System (IDERMS) in order to maintain blindness. Before conducting the study, a training and calibration session for oral examination (ICDAS and DIAGnodent utilization) is planned for the main researcher with one specialist in dental public health and one specialist in paediatric dentistry with the aim to achieve the kappa values of inter and intra-reliability ≥0.8.
Next, after the screening and before consent, if the child is eligible for the study, parents or guardians will be provided with information about SDF and NaF, follow-up instructions, oral hygiene instruction and diet education which will use video and pamphlet. Parents and guardians who agreed to participate in the study will be given questionnaire which include children's demographic background, oral-health related habits, and Malay- ECOHIS together with the information sheet and consent sheet. Appointment for first topical fluoride application will be given within one week from baseline oral examination day.
On the first appointment day, the allocation of patient between 38% SDF application and 5 % NaF application is randomized using sequentially numbered, opaque sealed envelopes (SNOSE) procedure (Doig \& Simpson, 2005). Block of four and six will be used to ensure that similar numbers of patients are enrolled into each group and to ensure the prediction of allocation sequence impossible. The order of the blocks will be determined by flipping a coin. This will be carried out by a dental officer/postgraduate student who is not involved with the study. He/she will keep the piles of blocks and when participant comes for the intervention, he/she will ask the operator to select one envelope from the first pile of blocks according to allocated sequence and will prepare the treatment selected. After first application is completed, he/she also will be the one who will update the Integrated Dental Record Management System (IDERMS) on which treatment has been used for the respective participants in order for him/her to prepare the same treatment for the 1-month follow up. The topical fluoride applications will be carried out by the other three researchers who are not involved in the screening and assessing of the lesion activity. Before the study, they will be trained by a paediatric dental specialist who is not involved in the study for the clinical application procedure. This is a double-blind clinical trial where the main researcher is not aware of which treatment the participants will be receiving, the other researchers are not aware which treatment they are providing and participants are not aware of which treatment they are receiving.
Participants will be called again for second application of same treatment they received on the first appointment after one month. Final appointment follow-up examination will be given at three months after first application of the topical fluoride. Same examiner will conduct the follow-up oral examinations using the same equipment, procedure and diagnostic criteria as those used in the baseline examination. Another questionnaire inclusive of parental acceptability for SDF treatment on their children and OHRQoL (Malay-ECOHIS) will be distributed to the same parents or guardians and will be asked to complete the questionnaire survey. After study is completed, the participants will be assigned back to undergraduate students for definitive treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 38% SDF group | Active comparator | Other: 38% SDF group38% silver diamine fluoride will be applied on caries lesions on deciduous teeth with a minimum score of 05 as defined by the International Caries Detection and Assessment System (ICDAS) |
| 5% NaF group | Placebo comparator | Other: 5% NaF group5% sodium fluoride will be applied on caries lesions on deciduous teeth with a minimum score of 05 as defined by the International Caries Detection and Assessment System (ICDAS) |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Three to eight years old children. The reason for selecting children up to eight years old is because there are still patients aged seven to eight years old who presented with posterior deciduous teeth and upper lateral incisor deciduous teeth caries. Children below three years old are not included in order to obtain better cooperation from the participants.
- Children who are generally healthy, not medically compromised
- Children who have at least one active carious lesion on a deciduous tooth which include upper anterior teeth caries (c-c) with a minimum score of 05 as defined by the International Caries Detection and Assessment System (ICDAS)
- Provision of informed consent by the parent or guardian
Key exclusion criteria (5 listed)
- Children with spontaneous or elicited pain from caries, tooth mobility, or signs of pulpal infection
- Children with severe medical conditions that would not allow management in the clinic
- Children with hereditary developmental defects, such as amelogenesis imperfecta
- Children with known allergies or sensitivities to dental materials, including silver diamine fluoride and sodium fluoride
- Inability to cooperate for silver diamine fluoride treatment or return for recall visits 3 months
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 |
|---|---|---|
| 38% SDF groupParticipants will be randomized and will receive either 38% SDF treatment or 5% NaF treatment | Other | 38% SDF group |
| 5% NaF groupParticipants will be randomized and will receive either 38% SDF treatment or 5% NaF treatment | Other | 5% NaF group |
Primary outcome
Caries arrest rate
Time frame: 3 months
After SDF or NaF application, after 3 months assessment, smooth and hard tooth surface that could not be penetrated by probe easily will be classified as arrested lesion. Caries arrest rate will be calculated by the percentage of all arrested lesions over all treatment applied teeth in respective arm. DIAGNOdent reading will be taken for all lesions before and after treatment in which DIAGNOdent reading ≥ 16 is indicated more likely to develop dentin caries after 24 mos.
1 secondary outcome
Oral Health-Related Quality of Life
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- 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.
Intan Elliayana binti Mohammed principal investigator
Faculty of Dentistry, Universiti Teknologi Mara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 38% SDF group and 5% NaF group in people with Dental Caries and Quality of Life, run by Universiti Teknologi Mara at 1 site in Malaysia.
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 4 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: status not confirmed, as of the sponsor's last update on 18 Nov 2023. 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 Malaysia. 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. Some participants in this study may receive a placebo. 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?
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?
Caries arrest rate (time frame: 3 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 18 Nov 2023.