RecruitingNot Applicable

SMART With Different Modifications in Asymptomatic Deep Carious Lesions of Primary Molars.

Turkey (Türkiye)150 participantsStarted 2025-01-01

Plain-language summary

This study aimed to evaluate the clinical success of the 'Silver Modified Atraumatic Restorative Technique '(SMART) with different modifications in asymptomatic deep carious lesions of primary molars.

Who can participate

Age range

4 Years – 9 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

. Patients and parents of the patients who accept to participate and sign the informed consent.
. Children between the ages of 4-9
. 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 II index: code 4,5,6) affecting primary molars.
. Absence of former history of spontaneous pain from the offending tooth/teeth.
. Patients with an appropriate level of cooperation to complete treatment under clinical conditions.
. Teeth are in a restorable condition.
. Natural exfoliation of primary teeth to be treated should not be expected within two years.

Exclusion criteria

. Patients and parents of the patients who does not accept to participate and sign the informed consent
. Patients with proven allergy to silver compounds or any component of dental materials to be applied.

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

1.Change from 3 months to 12 months regarding "Anatomic form"

Timeframe: 3-month,6-month,12 month

Change from 3 months to 12 months regarding "Marginal adaptation"

Timeframe: 3-month,6-month,12 month

Change from 3 months to 12 months regarding "Surface roughness"

Timeframe: 3-month,6-month,12 month

Change from 3 months to 12 months regarding "Marginal staining"

Timeframe: 3-month,6-month,12 month

Change from 3 months to 12 months regarding "Retention"

Timeframe: 3-month,6-month,12 month

Change from 3 months to 12 months regarding "Incisal wear"

Timeframe: 3-month,6-month,12 month

Functional properties according to revised FDI (World Dental Federation) criteria.

Timeframe: 3-month,6-month,12 month

Trial details

NCT IDNCT06645860

SponsorÇanakkale Onsekiz Mart University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-01

Contact for this trial

HİLAL ÖZTÜRK Research Assistant

00905312591404 hilalozturk98@gmail.com

View on ClinicalTrials.gov More Caries; Dentin trials

Who can participate

Age range

4 Years – 9 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

. Patients and parents of the patients who accept to participate and sign the informed consent.
. Children between the ages of 4-9
. 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 II index: code 4,5,6) affecting primary molars.
. Absence of former history of spontaneous pain from the offending tooth/teeth.
. Patients with an appropriate level of cooperation to complete treatment under clinical conditions.
. Teeth are in a restorable condition.
. Natural exfoliation of primary teeth to be treated should not be expected within two years.

Exclusion criteria

. Patients and parents of the patients who does not accept to participate and sign the informed consent
. Patients with proven allergy to silver compounds or any component of dental materials to be applied.

What they're measuring

1.Change from 3 months to 12 months regarding "Anatomic form"

Timeframe: 3-month,6-month,12 month

Change from 3 months to 12 months regarding "Marginal adaptation"

Timeframe: 3-month,6-month,12 month

Change from 3 months to 12 months regarding "Surface roughness"

Timeframe: 3-month,6-month,12 month

Change from 3 months to 12 months regarding "Marginal staining"

Timeframe: 3-month,6-month,12 month

Change from 3 months to 12 months regarding "Retention"

Timeframe: 3-month,6-month,12 month

Change from 3 months to 12 months regarding "Incisal wear"

Timeframe: 3-month,6-month,12 month

Functional properties according to revised FDI (World Dental Federation) criteria.

Timeframe: 3-month,6-month,12 month