An Early Phase 1 interventional study of NSF and SDF+KI in White Spot Lesion of Tooth, sponsored by Plovdiv Medical University. Recruiting at 1 site in Bulgaria. Open to participants aged 3 Years to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-05.
Sponsored by Plovdiv Medical University · Early Phase 1, Interventional, and Treatment
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.
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.
Plovdiv Medical University is the lead sponsor of 16 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The Gr-N will receive treatment with green synthesized Nano silver fluoride which is laboratory conducted
Drug: NSF
The Gr-S will receive treatment with SDF + KI (Riva Star 38% , SDI) according to the manufacturer's instructions.
Drug: SDF+KI
The control group (Gr-C) receive no intervention except brushing twice daily with aminofluoride toothpaste and toothbrush provided by researcher.
Other: Control group
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.
Also known as: 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 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.
Also known as: Riva star 38%, SDI
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.
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.
Time frame: 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.
Time frame: 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
Time frame: 12 months (Baseline, 1 month, 3 months, 6 months and 12 months)
Plan to share: No
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Plovdiv Medical University