Remineralizing Effect of Different Silver-containing Agents on Initial Caries Lesions in Primary Teeth in Children

NCT06489093 | Recruiting Early Phase 1

• 1 other identifier: P-841/08.04.2024
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

White Spot Lesion of Tooth

Keywords

sdf; nano silver fluoride; white spot lesions

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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

  12 months (Baseline, 1 month, 3 months, 6 months and 12 months)

Study Arms (3)

NSF (Gr-N)

EXPERIMENTAL

The Gr-N will receive treatment with green synthesized Nano silver fluoride which is laboratory conducted

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.

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.

Other: Control group

Interventions

NSF DRUG

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

NSF (Gr-N)

SDF+KI DRUG

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

SDF+KI group (Gr-S)

Control group OTHER

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.

Control group (Gr-C)

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• Children with no history of allergy to the medications administered.

You may not qualify if:

• 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 with a history of allergy to the administered medication.

Sponsors & Collaborators

• Plovdiv Medical University: lead

Study Sites (1)

Department of Pediatric Dentistry, Faculty of Dental Medicine, Medical University-Plovdiv

Plovdiv, 4000, Bulgaria

RECRUITING

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Antonia Palankalieva, DMD

  Department Of Pediatric Dentistry, Faculty Of Dental Medicine, Medical University Of Plovdiv, Bulgaria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonia Palankalieva, DMD

CONTACT

+359889205904; antonia.palankalieva@mu-plovdiv.bg

Ani Belcheva, DMD, PhD

CONTACT

+359889528932; ani.belcheva@mu-plovdiv.bg

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 5, 2024
• Study Start: July 29, 2024
• Primary Completion: May 1, 2025
• Study Completion: June 1, 2025
• Last Updated: July 5, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)