UnknownPhase 4

Treatment of Early Childhood Caries Using Silver Diammine Fluoride and Sodium Fluoride Tricalciumphosphate and the Effects on Oral Health Related Quality of Life

Pakistan72 participantsStarted 2022-01-18

Plain-language summary

There is still a need for the assessment of different minimal intervention strategies and treatments focusing on the prevention and arrest of carious lesions of primary molars The evidence-based clinical practice guideline on non-restorative treatments for cavitated carious lesions advocate the use of silver diammine fluoride biannually for high caries risk patients

Who can participate

Age range

4 Years – 6 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: Children will be invited to participate in the trial if they fulfil the entire selection criteria as described below: * 4 to 6 years-of-age * Identification of one or more carious primary molars without involvement of the pulp confirmed by bitewing radiographs * Up to three teeth per each participant will be selected for intervention * Has normal salivary flow rate * Does not consume medications regularly for any medical condition * Has not or will not receive any fluoride therapy or relevant dental therapy from other dental sources within the last six months Exclusion criteria: Children will be excluded from the trial if they fulfil any of the following criteria: * Presence of any pain, ulceration, fistula/sinus or an abscess * Premature hypermobility of carious teeth which can be potentially included in the study * History of allergy to any product containing silver compounds * Siblings of the participants will not be allowed to participate to ensure any chance of ECOHIS duplication.

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

Caries prevalence

Timeframe: Baseline

Frequency distribution of caries risk

Timeframe: Baseline

Mean score of oral health impact

Timeframe: Baseline

Patient behaviour towards dental treatment

Timeframe: Baseline

Mean score of pain experience

Timeframe: Baseline

Mean value of caries experience

Timeframe: Baseline

Extent of selected cavitated carious lesion using ICDAS

Timeframe: Baseline

Extent of selected cavitated carious lesion using FOTI

Timeframe: Baseline

Trial details

NCT IDNCT05772039

SponsorUniversiti Sains Malaysia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-15

View on ClinicalTrials.gov More Early Childhood Caries trials

Plain-language summary

Who can participate

Age range

4 Years – 6 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

Caries prevalence

Timeframe: Baseline

Frequency distribution of caries risk

Timeframe: Baseline

Mean score of oral health impact

Timeframe: Baseline

Patient behaviour towards dental treatment

Timeframe: Baseline

Mean score of pain experience

Timeframe: Baseline

Mean value of caries experience

Timeframe: Baseline

Extent of selected cavitated carious lesion using ICDAS

Timeframe: Baseline

Extent of selected cavitated carious lesion using FOTI

Timeframe: Baseline