White Spot Lesion of ToothEarly Phase 1NCT06489093
Remineralizing Effect of Different Silver-containing Agents on Initial Caries Lesions in Primary Teeth in Children
A Early Phase 1 study testing NSF and SDF+KI in people with White Spot Lesion of Tooth, run by Plovdiv Medical University at 1 site in Bulgaria.
Trial summary
The aim of the present work is to study the effect of the application of Silver diamine fluoride (SDF) and a novel green synthesized Nano-silver fluoride (NSF) on early enamel lesions in primary teeth. Read more about this study
- Who is it for?
- Ages 3 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesion of Tooth
- What is being tested?
- NSF and SDF+KI
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBulgaria
- Study dates
- 29 Jul 2024to Jun 2025
- Phase
- Early Phase 1
- 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
- Age: 3 - 8 years
- Signed informed consent from parents to participate in the study. Verbal consent from the child for the upcoming manipulations.
- Enrolled patients do not have any common diseases or conditions associated with decreased salivation and are not taking medications that suppress salivary flow. Study participants have no cognitive or behavioral impairment. The absence of disease will be confirmed by a history-taking interview with the parent.
- Presence of incipient carious lesions (white spots) reaching the enamel interior, assessed with ICDAS system values 01 (first visible enamel change) and 02 (localized visible enamel change) and laser fluorescence values up to 20. The diagnostic threshold of the included lesions is defined as D1 A (active enamel lesion visible after drying) or D2 A (active enamel lesion visible without drying). Criteria for active lesions: under plaque, loss of gloss, loss of smoothness, diffuse borders of the lesion, opaque appearance, white colour, at pre-selection sites (in the cervical third of the enamel). The lesions are located on tooth surfaces with no preceding obturations.
- Study participants had not performed remineralization or topical fluoride therapy on the included lesions within six months prior to study inclusion.
- Children with no history of allergy to the medications administered.
Who cannot join
- Children who are considered medically compromised or medically complex patients. The presence of a medical condition is confirmed by a history interview with the child's parent or guardian and involves common diseases or conditions associated with decreased salivation and intake of medications that suppress salivary flow, cognitive and behavioral disorders.
- Patients who underwent remineralizing or topical fluoride therapy to the included lesions in the last six months prior to study inclusion.
- Patients with a history of allergy to the administered medication.
Trial locations and contacts
1 site in 1 country.
Bulgaria1 site, 1 recruiting
- Recruiting
Department of Pediatric Dentistry, Faculty of Dental Medicine, Medical University-Plovdiv
Plovdiv, 4000
Antonia Palankalieva, DMD, +359889205904, antonia.palankalieva@mu-plovdiv.bg
About this study
Official title: Evaluation of the Effect of Green Synthesized Nano-silver Fluoride and Silver Diamine Fluoride on Carious Lesions in Children
The aim of the present work is to study the effect of the application of Silver diamine fluoride (SDF) and a novel green synthesized Nano-silver fluoride (NSF) on early enamel lesions in primary teeth. Proving their positive effect would be the basis for the development of innovative dental materials and hygienic agents to combat the carious process, which is a critical prerequisite for improving the quality of dental services and reducing dental anxiety and fear.
Read the detailed description
Dental caries is a major public health concern, especially in very young children. Early detection of the disease enhances and simplifies treatment effectiveness. Non-operative treatments are particularly advantageous as they are minimally invasive, reduce future operative treatment needs and are more comfortable, thereby improving overall compliance and dental experience.
The aim of the study is to compare the clinical efficacy of Silver diamine fluoride (SDF) and laboratory prepared green synthesized Nano-silver fluoride on early enamel lesions in primary teeth.
The proposed study is a randomized controlled clinical trial. Included patients are healthy positive children aged from 3 to 8 years, requiring non-operative treatment of incipient caries lesions on smooth surfaces of primary teeth. Lesions will be assessed visually using ICDAS II, Nyvad criteria and laser fluorescence (LF pen).
Patients are randomly assigned to one of three study groups:
Group N: Green synthesized Nano silver fluoride (prepared in laboratory) Group S: SDF + KI (38% Riva Star, SDI) Group C: Control group
Prior to treatment parents are informed about the nature of the study and sign an informed consent. Children are introduced to the method of conducting treatment in a style appropriate for the child's age. Lesions are assesed using the ICDAS II system, Nyvad criteria and laser fluorescence. All patients receive professional oral hygiene with a fluoride-free brush and polishing paste. Treatment of each patient's respective teeth is performed following the treatment protocol of the respective agents. Follow-ups are performed at 1st, 3rd, 6th and 12th month.
- Conditions
- White Spot Lesion of Tooth
- Being tested
- NSF, SDF+KI, Control group
- Keywords
- sdf, nano silver fluoride, white spot lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NSFDrug
Also called green synthesized Nano silver fluoride
Prior to treatment the working field is isolated with cotton rolls. Gingival barrier is used for soft tissue protection. Application of NSF using a microapplicator on the carious lesion for 1 minute. Excess material and gingival barrier are removed. Participants receive oral hygiene instructions.
SDF+KIDrug
Also called Riva star 38%, SDI
Prior to treatment the working field is isolated with cotton rolls. Gingival barrier is used for soft tissue protection. Application of 38% silver diamine fluoride (Riva star 38%, SDI) using a microapplicator on the carious lesion. Immediately afterwards, potassium iodide is applied as a reducing agent. Excess material and gingival barrier are removed. Participants receive oral hygiene instructions.
Control groupOther
Subjects will receive oral hygiene instructioins to apply fluoridated toothpaste to a toothbrush and brush teeth thoroughly for at least 2 minutes, then expectorate and rinse.
| Study group | Role | What they receive |
|---|---|---|
| NSF (Gr-N) | Experimental | The Gr-N will receive treatment with green synthesized Nano silver fluoride which is laboratory conducted Receives: Drug: NSF |
| SDF+KI group (Gr-S) | Active comparator | The Gr-S will receive treatment with SDF + KI (Riva Star 38% , SDI) according to the manufacturer's instructions. Receives: Drug: SDF+KI |
| Control group (Gr-C) | Placebo comparator | The control group (Gr-C) receive no intervention except brushing twice daily with aminofluoride toothpaste and toothbrush provided by researcher. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual assessment using ICDAS II coding system
Code 0: Sound tooth surface Code 1: First visual change in enamel. Code 2: Distinct visual change in enamel visible when wet, lesion must be visible when dry.
Code 3: Localized enamel breakdown because of caries with no visible dentin or underlying shadow.
Code 4: Underlying dark shadow from dentin with or without localized enamel breakdown.
Code 5: Distinct cavity with visible dentin. Code 6: Extensive distinct cavity with visible dentin.
After treatment, the evaluation will be performed as follows: Increase to ICDAS 3 or more indicates caries progression; decrease to 0-1 this indicates caries regression. If score remains the same this indicates no change in lesion.
No. of lesions with scores 0,1,2,3 or more will be assessed and analyzed.
Measured: 12 months (Baseline, 1 month, 3 months, 6 months and 12 months)
Activity of a carious lesion using Nyvad Caries Diagnostic Criteria
Code 0: Sound (normal) enamel Code 1: Active caries (intact surface) - Surface of enamel is whitish/yellowish opaque Code 2: Active caries (surface discontinuity) Code 3: Active caries (cavity) - Enamel/dentin cavity easily visible with the naked eye.
Code 4: Inactive caries (intact surface) - Surface of enamel is whitish, brownish or black.
Code 5: Inactive caries (surface discontinuity) - Same criteria as score 4. Localized surface defect (microcavity) in enamel only Code 6: Inactive caries (cavity) - Enamel/dentin cavity easily visible with the naked eye; surface of cavity may be shiny and feels hard on probing with gentle pressure.
Code 7: Filling (sound surface) Code 8: Filling + active caries - Caries lesion may be cavitated or noncavitated.
Code 9: Filling + inactive caries - Caries lesion may be cavitated or noncavitated.
Measured: 12 months (Baseline, 1 month, 3 months, 6 months and 12 months)
Change in lesion fluorescence evaluated using diode laser fluorescence device
Laser fluorescence values are categorized using the following scale:
0-5 - no change 5-10 - enamel caries located in the outer enamel surface 10-15 - enamel caries located to the middle of the enamel 15-20 - enamel caries reaching the dentine enamel junction >20 - caries in the dentine
Measured: 12 months (Baseline, 1 month, 3 months, 6 months and 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start29 Jul 2024 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for White Spot Lesion of ToothStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Plovdiv Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonia Palankalieva, DMD, Principal investigator, Department Of Pediatric Dentistry, Faculty Of Dental Medicine, Medical University Of Plovdiv, Bulgaria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06489093
- Sponsor's protocol ID
- P-841/08.04.2024
- Status last verified
- Jun 2024
- First submitted
- 27 Jun 2024
- Last updated
- 5 Jul 2024
- 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 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Green Synthesized Nano-silver Fluoride and Silver Diamine Fluoride on Carious Lesions in Children
- ClinicalTrials.gov ID
- NCT06489093
- Acronym / sponsor ID
- P-841/08.04.2024
- Conditions
- White Spot Lesion of Tooth
- Keywords
- sdf, nano silver fluoride, white spot lesions
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Plovdiv Medical UniversityUniversity, hospital or other
- Study start
- 29 Jul 2024 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 5 Jul 2024 (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 present work is to study the effect of the application of Silver diamine fluoride (SDF) and a novel green synthesized Nano-silver fluoride (NSF) on early enamel lesions in primary teeth. Proving their positive effect would be the basis for the development of innovative dental materials and hygienic agents to combat the carious process, which is a critical prerequisite for improving the quality of dental services and reducing dental anxiety and fear.
Detailed description
Dental caries is a major public health concern, especially in very young children. Early detection of the disease enhances and simplifies treatment effectiveness. Non-operative treatments are particularly advantageous as they are minimally invasive, reduce future operative treatment needs and are more comfortable, thereby improving overall compliance and dental experience.
The aim of the study is to compare the clinical efficacy of Silver diamine fluoride (SDF) and laboratory prepared green synthesized Nano-silver fluoride on early enamel lesions in primary teeth.
The proposed study is a randomized controlled clinical trial. Included patients are healthy positive children aged from 3 to 8 years, requiring non-operative treatment of incipient caries lesions on smooth surfaces of primary teeth. Lesions will be assessed visually using ICDAS II, Nyvad criteria and laser fluorescence (LF pen).
Patients are randomly assigned to one of three study groups:
Group N: Green synthesized Nano silver fluoride (prepared in laboratory) Group S: SDF + KI (38% Riva Star, SDI) Group C: Control group
Prior to treatment parents are informed about the nature of the study and sign an informed consent. Children are introduced to the method of conducting treatment in a style appropriate for the child's age. Lesions are assesed using the ICDAS II system, Nyvad criteria and laser fluorescence. All patients receive professional oral hygiene with a fluoride-free brush and polishing paste. Treatment of each patient's respective teeth is performed following the treatment protocol of the respective agents. Follow-ups are performed at 1st, 3rd, 6th and 12th month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NSF (Gr-N) | Experimental | Drug: NSFThe Gr-N will receive treatment with green synthesized Nano silver fluoride which is laboratory conducted |
| SDF+KI group (Gr-S) | Active comparator | Drug: SDF+KIThe Gr-S will receive treatment with SDF + KI (Riva Star 38% , SDI) according to the manufacturer's instructions. |
| Control group (Gr-C) | Placebo comparator | Other: Control groupThe control group (Gr-C) receive no intervention except brushing twice daily with aminofluoride toothpaste and toothbrush provided by researcher. |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age: 3 - 8 years
- Signed informed consent from parents to participate in the study. Verbal consent from the child for the upcoming manipulations.
- Enrolled patients do not have any common diseases or conditions associated with decreased salivation and are not taking medications that suppress salivary flow. Study participants have no cognitive or behavioral impairment. The absence of disease will be confirmed by a history-taking interview with the parent.
- Presence of incipient carious lesions (white spots) reaching the enamel interior, assessed with ICDAS system values 01 (first visible enamel change) and 02 (localized visible enamel change) and laser fluorescence values up to 20. The diagnostic threshold of the included lesions is defined as D1 A (active enamel lesion visible after drying) or D2 A (active enamel lesion visible without drying). Criteria for active lesions: under plaque, loss of gloss, loss of smoothness, diffuse borders of the lesion, opaque appearance, white colour, at pre-selection sites (in the cervical third of the enamel). The lesions are located on tooth surfaces with no preceding obturations.
- Study participants had not performed remineralization or topical fluoride therapy on the included lesions within six months prior to study inclusion.
Key exclusion criteria (3 listed)
- Children who are considered medically compromised or medically complex patients. The presence of a medical condition is confirmed by a history interview with the child's parent or guardian and involves common diseases or conditions associated with decreased salivation and intake of medications that suppress salivary flow, cognitive and behavioral disorders.
- Patients who underwent remineralizing or topical fluoride therapy to the included lesions in the last six months prior to study inclusion.
- Patients with a history of allergy to the administered medication.
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 |
|---|---|---|
| NSFAlso: green synthesized Nano silver fluoridePrior to treatment the working field is isolated with cotton rolls. Gingival barrier is used for soft tissue protection. Application of NSF using a microapplicator on the carious lesion for 1 minute. Excess material and gingival barrier are removed. Participants receive oral hygiene instructions. | Drug | NSF (Gr-N) |
| SDF+KIAlso: Riva star 38%, SDIPrior to treatment the working field is isolated with cotton rolls. Gingival barrier is used for soft tissue protection. Application of 38% silver diamine fluoride (Riva star 38%, SDI) using a microapplicator on the carious lesion. Immediately afterwards, potassium iodide is applied as a reducing agent. Excess material and gingival barrier are removed. Participants receive oral hygiene instructions. | Drug | SDF+KI group (Gr-S) |
| Control groupSubjects will receive oral hygiene instructioins to apply fluoridated toothpaste to a toothbrush and brush teeth thoroughly for at least 2 minutes, then expectorate and rinse. | Other | Control group (Gr-C) |
Primary outcome
Visual assessment using ICDAS II coding system
Time frame: 12 months (Baseline, 1 month, 3 months, 6 months and 12 months)
Code 0: Sound tooth surface Code 1: First visual change in enamel. Code 2: Distinct visual change in enamel visible when wet, lesion must be visible when dry. Code 3: Localized enamel breakdown because of caries with no visible dentin or underlying shadow. Code 4: Underlying dark shadow from dentin with or without localized enamel breakdown. Code 5: Distinct cavity with visible dentin. Code 6: Extensive distinct cavity with visible dentin. After treatment, the evaluation will be performed as follows: Increase to ICDAS 3 or more indicates caries progression; decrease to 0-1 this indicates caries regression. If score remains the same this indicates no change in lesion. No. of lesions with scores 0,1,2,3 or more will be assessed and analyzed.
Activity of a carious lesion using Nyvad Caries Diagnostic Criteria
Time frame: 12 months (Baseline, 1 month, 3 months, 6 months and 12 months)
Code 0: Sound (normal) enamel Code 1: Active caries (intact surface) - Surface of enamel is whitish/yellowish opaque Code 2: Active caries (surface discontinuity) Code 3: Active caries (cavity) - Enamel/dentin cavity easily visible with the naked eye. Code 4: Inactive caries (intact surface) - Surface of enamel is whitish, brownish or black. Code 5: Inactive caries (surface discontinuity) - Same criteria as score 4. Localized surface defect (microcavity) in enamel only Code 6: Inactive caries (cavity) - Enamel/dentin cavity easily visible with the naked eye; surface of cavity may be shiny and feels hard on probing with gentle pressure. Code 7: Filling (sound surface) Code 8: Filling + active caries - Caries lesion may be cavitated or noncavitated. Code 9: Filling + inactive caries - Caries lesion may be cavitated or noncavitated.
Change in lesion fluorescence evaluated using diode laser fluorescence device
Time frame: 12 months (Baseline, 1 month, 3 months, 6 months and 12 months)
Laser fluorescence values are categorized using the following scale: 0-5 - no change 5-10 - enamel caries located in the outer enamel surface 10-15 - enamel caries located to the middle of the enamel 15-20 - enamel caries reaching the dentine enamel junction >20 - caries in the dentine
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- 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.
Antonia Palankalieva, DMD principal investigator
Department Of Pediatric Dentistry, Faculty Of Dental Medicine, Medical University Of Plovdiv, Bulgaria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing NSF and SDF+KI in people with White Spot Lesion of Tooth, run by Plovdiv Medical University at 1 site in Bulgaria.
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 6 inclusion and 3 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 2024. 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 Bulgaria. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Antonia Palankalieva, DMD (+359889205904, antonia.palankalieva@mu-plovdiv.bg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual assessment using ICDAS II coding system (time frame: 12 months (Baseline, 1 month, 3 months, 6 months and 12 months)). The study lists 3 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 5 Jul 2024.