Clinical trial NCT06861725: CARIES ARREST USING SILVER DIAMINE FLUORIDE VERSUS FISSURE SEALANT in OCCLUSAL DENTAL CARIOUS LESIONS: RANDOMIZED CONTROLLED TRIAL
Official title: CARIES ARREST USING SILVER DIAMINE FLUORIDE VERSUS FISSURE SEALANT in OCCLUSAL DENTAL CARIOUS LESIONS: RANDOMIZED CONTROLLED TRIAL
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dental Caries
Caries Arrested
Silver Diamine Fluoride
Fissure Sealant
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 76
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .

Detailed description: This randomized clinical trial aims to assess the efficacy of Silver Diamine Fluoride (SDF) compared to fissure sealant in arresting mild occlusal caries. The study is focused on patients aged 20 to 45 years who present with incipient caries in the molar teeth, classified under ICDAS 1 and 2. The study will be conducted at the Cairo University Dental Hospital, a tertiary healthcare and referral center.

The null hypothesis is there is no difference in the clinical performance between the application of silver diamine fluoride and fissure sealant in occlusal dental carious lesions.

Participants will be randomly assigned to one of two groups:

SDF Group: Silver Diamine Fluoride (38%) will be applied to the affected tooth surface. The treatment will be carried out by isolating the tooth, drying it thoroughly, applying SDF using a microbrush, and allowing it to remain on the surface for up to 3 minutes. Afterward, any excess will be removed, and the patient will be advised to avoid eating for 30 minutes.

Fissure Sealant Group: Fissure sealant (resin-based) will be applied to the affected occlusal surface. This procedure involves etching the surface with phosphoric acid, applying the sealant, and then curing it using a light-curing device. The sealant will form a protective barrier to prevent further demineralization.

The study will track two primary outcomes:

Caries progression, measured by the presence of visible cavitation or sensitivity during follow-up.

Caries arrest, determined through visual and tactile examination (e.g., probing to assess lesion hardness).

Secondary outcomes will include the formation of new caries, assessed using the DIAGNOdent laser fluorescence system.

Follow-up visits will occur at 1, 3, 6, and 12 months, where participants will be clinically assessed for pain, caries arrest, and new lesions. Clinical evaluations will include:

Visual and tactile examinations: Assessing the presence and activity level of carious lesions.

Caries progression: Identified by tactile detection with a dental explorer. Caries arrest: Lesions that have become hard and smooth will be considered arrested.

New caries: Monitored using the DIAGNOdent system for any signs of new decay. This trial will provide insight into whether SDF, a minimally invasive treatment, can offer a more effective and less expensive alternative to fissure sealants in arresting caries, especially in patients with early-stage occlusal caries.

Eligibility criteria: Inclusion Criteria:

1. Patient consulting in the outpatient clinic.
2. Patients with enamel caries in molars permanent teeth, according to ICDAS 1 and 2.
3. Provide informed consent.
4. Co-operative patients approving to participate in the trial.
5. Patient age (20-45 years old).

Exclusion Criteria:

1. Tooth mobility.
2. Signs of pulpal infection.
3. Severe medical conditions that would not allow management in the clinic.
4. Hereditary developmental defects, such as amelogenesis imperfecta or dentinogenesis imperfecta.
5. Known allergies or sensitivities to dental materials, including SDF and fissure sealant.
6. Inability to return for recall visits.
7. Patients with bad oral hygiene
8. Refuse to participate in the study.

Primary outcomes:
measure: detect clinical progression done by the presence of visible cavitation and/or sensitivity during follow-up, measured by visual criteria
timeFrame: 1-3-6 and 12 month
Secondary outcomes:
measure: evaluate carries arrest and new caries formation, measured by DIAGNOdent laser fluorescence system
timeFrame: 1-3-6 and 12 month
Other outcomes:
Locations:
Study officials:
affiliation: Professor of Esthetic and Conservative Dentistry, Faculty of Dentistry, Cairo University in Egypt.
name: Omaima Safwat Hamza, Professor
role: STUDY_DIRECTOR
affiliation: Lecturer of Esthetic and Conservative Dentistry, Faculty of Dentistry, Cairo University.
name: Dina Mounir El-Kadi
role: STUDY_DIRECTOR
References: