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

NCT06861725 | Not Yet Recruiting

• 1 other identifier: SDF VS FS in caries arrest
• Study Type: interventional
• Target: 76
• Locations: 0 countries
• Sites: N/A

Brief Summary

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 .

Conditions

Dental Caries; Caries Arrested; Silver Diamine Fluoride; Fissure Sealant

Outcome Measures

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.

  1-3-6 and 12 month

Secondary Outcomes (1)

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

  1-3-6 and 12 month

Study Arms (2)

VOCO Fissurit

ACTIVE COMPARATOR

Sealants are restorative dental materials applied to the pit-and-fissure surfaces of teeth. Upon application, the sealant material infiltrates the pits and fissures, subsequently polymerizing to form a hardened layer. This layer serves as a physical barrier, effectively preventing or restricting the penetration of bacteria and nutrients, thereby mitigating the risk of caries formation in these susceptible areas. Pit and fissure sealants: Evidence-based recommendations support the use of sealants for the prevention and management of pit and fissure caries. Sealants are effective and should be applied to the occlusal surfaces of first and second permanent molars. Additionally, non-operative cleaning of fissures with a toothbrush or bristle brush is recommended.

Other: VOCO Fissurit

Silver Diamine Fluoride (SDF)

EXPERIMENTAL

Advantage Arrest Silver Diamine Fluoride 38%-SDF is an anti-microbial and remineralizing liquid clinically applied to control and arrest active dental caries and stop hypersensitivity. It is a safe, painless alternative to traditional cavity drilling procedures with the Power of Silver and Fluoride. Silver acts as an antimicrobial agent that simultaneously strengthens the dentin. Fluoride is the active ingredient that puts a stop to tooth decay by remineralising and helps prevent additional decay from appearing. It is also helpful to get relief from hypersensitivity. The only common side effect is SDF causes black staining, but SDF/KI and NSF may reduce this staining effect. SDF can also stain surfaces that it comes into contact with when being applied, such as clothing or nearby tissues in the mouth. For best results, SDF should be reapplied every 3, 6, or 12 months, If the cavity still progresses.

Other: Silver Diamine Fluoride (SDF)

Interventions

Silver Diamine Fluoride (SDF) OTHER

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.

Silver Diamine Fluoride (SDF)

VOCO Fissurit OTHER

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

VOCO Fissurit

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Patient age (20-45 years old).

You may not qualify if:

• 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.
• Known allergies or sensitivities to dental materials, including SDF and fissure sealant.
• Inability to return for recall visits.
• Patients with bad oral hygiene
• Refuse to participate in the study.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Dental Caries

Interventions

silver diamine fluoride

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Omaima Safwat Hamza, Professor

  Professor of Esthetic and Conservative Dentistry, Faculty of Dentistry, Cairo University in Egypt.

  STUDY DIRECTOR

• Dina Mounir El-Kadi

  Lecturer of Esthetic and Conservative Dentistry, Faculty of Dentistry, Cairo University.

  STUDY DIRECTOR

Central Study Contacts

Amr Abir Atmaz Alsibaee, Master's student

CONTACT

(+20)1093034394; Amr.alsibaee@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Biostatistics: The study was divided into two groups, Group A and Group B. The materials used in each group were blinded to the statisticians conducting the analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.Amr Abir Atmaz Alsibaee

Study Record Dates

• First Submitted: March 1, 2025
• First Posted: March 6, 2025
• Study Start: April 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share