Health TrialsbyHealthPanel

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

ConditionCaries; Dentin
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-9
SponsorÇanakkale Onsekiz Mart University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Patients with special health care needs or any medical conditions.

Primary molar teeth with excessive crown damage that cannot be restored.

Trial design

Design model

Parallel

Treatments tested in this trial

  • SDF+KI+LED Light 20s

    Procedure/Surgery

    After the silver diamine fluoride (SDF) and potassiım iodide (KI) application, 20-second LED light will be applied to the cavity.

  • SDF+KI

    Procedure/Surgery

    Silver diamine fluoride (SDF) and potassium iodide(KI) will be applied.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Silver Diamine Fluoride+Potassium Iodide+Led LightExperimental treatment 2 interventions
Group B: Silver Diamine Fluoride(Control)Other 1 intervention

Trial outcomes

Primary outcomes

1

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

alpha: The general contour of the restorations follows the contour bravo: the general contour of the restoration does not follow the contour of the tooth charlie: The restoration has an overhang does

Time frame
3-month,6-month,12 month
2

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

alpha: Explorer does not catch or has one-way catch when drawn across the restoration/tooth interface bravo: explorer falls into crevice drawn across the restoration/tooth interface charlie: Dentin or base is exposed along the margin

Time frame
3-month,6-month,12 month
3

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

alpha: the surface of the restoration does not have any surface defects bravo: the surface of the restoration has minimal surface defects charlie: the surface of the restoration has severe surface defects

Time frame
3-month,6-month,12 month
4

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

alpha: there is no discoloration between the restorations and tooth bravo: there is discoloration on less than half of the circumferential margin charlie: there is discoloration on more than half of the circumferential margin

Time frame
3-month,6-month,12 month

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Çanakkale Onsekiz Mart University

Lead sponsor

Source ClinicalTrials.gov
Apply now