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

Launched by PLOVDIV MEDICAL UNIVERSITY · Jul 3, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how effective two different treatments are for fixing early tooth decay in young children. The treatments being tested are Silver diamine fluoride (SDF) and a new type of silver treatment called Nano-silver fluoride (NSF). Both aim to help improve the condition of early enamel lesions, which are those white spots you might see on a child’s teeth. The goal is to find out if these treatments can help prevent further decay and make dental care less stressful for kids.

To be eligible for this trial, children must be between 3 to 8 years old and have specific early signs of tooth decay without any major health issues that could affect their saliva production. Parents must give permission for their child to participate, and the child should be able to understand and agree to the treatments. Participants will not have received any similar treatments in the past six months. Those who join the study can expect to receive one of the treatments and be monitored to see how well it works. This research is important because it may lead to new, effective ways to keep children’s teeth healthy and reduce anxiety about dental visits.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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.