UnknownPhase 4

SDF Effectiveness on Arresting Caries in Children

Saudi Arabia60 participantsStarted 2023-06-01

Plain-language summary

Purpose: To assess the clinical effectiveness of silver diamine fluoride (SDF) to control asymptomatic cavitated carious lesions compared to conventional glass ionomer restoration in preschool children.

Who can participate

Age range

5 Years – 7 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Healthy children without a history of serious systemic conditions necessitating chronic use of medications. * Children whose dental examination reveals at least one untreated asymptomatic cavitated carious lesion (ICDAS index: code 3-5) affecting primary molars. * Absence of former history of spontaneous pain from the offending tooth/teeth. * Teeth with normal vital pulp response when assessed using sensibility test and absence of any signs of irreversible pulpitis or necrotic pulp degeneration. * Absence of abnormal grade of tooth mobility, swelling, or tenderness on palpation or percussion. * Absence of any evidence of peri-radicular pathosis, or internal- or external resorption on radiographic examination. Exclusion Criteria: * Patients with proven allergy to silver compounds or any component of dental materials to be applied. * Patients or guardians who refuse to participate in the study or had poor acceptance of SDF treatment. * Patients with ulcerative gingivitis or stomatitis.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean Change from Baseline in Dental Caries Lesions using ICDAS score at Week 24

Timeframe: Baseline and Week 24

Mean Change from Baseline in Dental Caries Lesions using dmfs index at Week 24

Timeframe: Baseline and Week 24

Change from Baseline in Dental Caries Activity using Arrested or Active caries characteristics at Week 24

Timeframe: Baseline and Week 24

Mean Change from Baseline in Dental Caries Susceptibility using the CariScreen Caries Susceptibility Testing meter at Week 24

Timeframe: Baseline and Week 24

Trial details

NCT IDNCT05872542

SponsorUmm Al-Qura University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-31

Contact for this trial

Abla Arafa

+966543869336 ablaarafa@hotmail.com

View on ClinicalTrials.gov More Dental Caries in Children trials

Who can participate

Age range

5 Years – 7 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Mean Change from Baseline in Dental Caries Lesions using ICDAS score at Week 24

Timeframe: Baseline and Week 24

Mean Change from Baseline in Dental Caries Lesions using dmfs index at Week 24

Timeframe: Baseline and Week 24

Change from Baseline in Dental Caries Activity using Arrested or Active caries characteristics at Week 24

Timeframe: Baseline and Week 24

Mean Change from Baseline in Dental Caries Susceptibility using the CariScreen Caries Susceptibility Testing meter at Week 24

Timeframe: Baseline and Week 24