CARIES ARREST USING SILVER DIAMINE FLUORIDE VERSUS FISSURE SEALANT in OCCLUSAL DENTAL CARIOUS LESIONS: RANDOMIZED CONTROLLED TRIAL

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-45
SponsorCairo University

About this trial

The goal of this randomized clinical trial is to evaluate if Silver Diamine Fluoride (SDF) is a more conservative and effective treatment in preventing the progression of mild occlusal caries compared to fissure sealant in patients aged 20-45 years with incipient molar caries. The main question it aims to answer is:

Is SDF more effective in arresting caries progression than fissure sealant? Does SDF prevent the formation of new caries compared to fissure sealant? Researchers will compare SDF treatment to fissure sealant application to see if SDF results in better caries arrest and fewer new carious lesions.

Participants will:

Be randomly assigned to receive either SDF or fissure sealant. Have follow-up assessments at 1, 3, 6, and 12 months for caries progression, arrest, and new caries formation.

Undergo clinical evaluations using visual and tactile examinations to assess caries arrest and progression and using DIAGNOdent laser fluorescence system .

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient consulting in the outpatient clinic.

Patients with enamel caries in molars permanent teeth, according to ICDAS 1 and 2.

Provide informed consent.

Co-operative patients approving to participate in the trial.

Disqualifiers

Tooth mobility.

Signs of pulpal infection.

Severe medical conditions that would not allow management in the clinic.

Hereditary developmental defects, such as amelogenesis imperfecta or dentinogenesis imperfecta.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Silver Diamine Fluoride (SDF)

    Other intervention

    Silver Diamine Fluoride has been used extensively around the globe for decades. Advantage Arrest silver diamine fluoride 38% will change how you offer your patients the protection they deserve. Advantage Arrest: Provides immediate relief from dentinal hypersensitivity Kills pathogenic organisms Hardens softened dentin making it more acid and abrasion resistant Does not stain sound dentin or enamel Can provide important clinical feedback due to its potential to stain visible or hidden lesions Silver diamine fluoride 38% is indicated for the treatment of dentinal hypersensitivity.

  • VOCO Fissurit

    Other intervention

    Transparent Light-cured pits and fissure sealant, with high stability and good adhesion to enamel

Treatment groups

76 Participants
are divided into 2 treatment groups
Group A: VOCO FissuritActive comparator 1 intervention
Group B: Silver Diamine Fluoride (SDF)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

detect clinical progression done by the presence of visible cavitation and/or sensitivity during follow-up, measured by visual criteria

detect clinical progression done by the presence of visible cavitation and/or sensitivity during follow-up, measured by visual criteria. The fissure sealant and SDF will be evaluated at each recall visit for caries arrest through visual and tactile assessment, Arrested caries treated with silver diamine fluoride is clinically characterized by increased hardness and dark brown to black coloration . The clinical examination of fissure sealants involved evaluating the presence of visible cavitation. Although lesions can be seen through sealants. Active caries will be identified when a blunt probe, applied with light pressure, can easily penetrate the lesion surface. Conversely, inactive (arrested) caries will be observed if the lesion surface is firm, smooth, and free from plaque. The number and percentage of arrested carious lesions will be recorded and assessed.

Time frame
1-3-6 and 12 month

Secondary outcomes

1

evaluate carries arrest and new caries formation, measured by DIAGNOdent laser fluorescence system

The DIAGNOdent system provides fluorescence scores that range from 0 to 99. These scores indicate the level of caries activity or demineralization in the tooth structure. -Score 0-13: Healthy Tooth Structure -Score 14-20: Early Demineralization/Initial Lesion Mild demineralization is present, which may be reversible. These lesions might not be cavitated but show early signs of enamel breakdown.. -Score 21-40: Moderate Demineralization Clear signs of enamel breakdown, but the lesion is still confined to the enamel without progressing to the dentin. -Score 41-60: Active Lesion Significant demineralization is occurring. -Score 61-99: Cavitation and Severe Active Caries Indicates severe decay or active caries.

Time frame
1-3-6 and 12 month

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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