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

NCT06645860 | Recruiting

• 1 other identifier: CanakkaleOMU5616
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Caries; Dentin

Outcome Measures

Primary Outcomes (9)

• 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

  3-month,6-month,12 month

• 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

  3-month,6-month,12 month

• 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

  3-month,6-month,12 month

• 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

  3-month,6-month,12 month

• Change from 3 months to 12 months regarding "Retention"

  alpha: intact bravo: chipped/loss of material charlie: complete loss of crown

  3-month,6-month,12 month

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

  alpha: intact bravo: wear of occlusal surface without tooth surface exposure charlie: wear of occlusal surface with tooth surface exposure

  3-month,6-month,12 month

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

  Functional properties: F2: Marginal adaptation measured by visual examination, short air drying, 250 μm probe. F3:Proximal contact point measured by visual examination and 25/50/100 μm blades. F4: Form and contour measured by visual examination. F5: Occlusion and occlusal wear measured by visual examination and articulation paper. Method of aggregation is frequency and percentage. Measuring unit is scoring system (Ordinal, scores 1-5). (1) Clinically excellent. (sufficient). (5) Clinically poor (entirely insufficient).

  3-month,6-month,12 month

• Biological properties according to revised FDI criteria.

  Biological properties: B1: Caries at restoration margin (CAR) measured by visual examination, short air drying, and 250 μm probe. B2: Dental hard tissue defects at restoration margin measured by visual examination. B3: Postoperative hypersensitivity reported by patient and pulp status tested with cold stimulus. Method of aggregation is frequency and percentage. Measuring unit is scoring system (Ordinal, scores 1-5). (1) Clinically excellent. (sufficient). (5) Clinically poor (entirely insufficient).

  3-month,6-month,12 month

• Aesthetic properties according to revised FDI criteria.

  Aesthetic properties: A1: Surface luster and surface texture measured by visual examination and short air drying. A2: Marginal staining measured by visual examination and short air drying. A3: color match measured by visual examination. Method of aggregation is frequency and percentage. Measuring unit is scoring system (Ordinal, scores 1-5). (1) Clinically excellent. (sufficient). (5) Clinically poor (entirely insufficient).

  3-month,6-month,12 month

Study Arms (2)

Silver Diamine Fluoride+Potassium Iodide+Led Light

EXPERIMENTAL

Following the silver diamine fluoride and potassium iodide application, LED light will be applied for 20 seconds.

Procedure: SDF+KI+LED Light 20s; Procedure: SDF+KI

Silver Diamine Fluoride(Control)

OTHER

Only silver diamine fluoride and potassium iodide solution will be applied.

Procedure: SDF+KI

Interventions

SDF+KI+LED Light 20s PROCEDURE

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

Silver Diamine Fluoride+Potassium Iodide+Led Light

SDF+KI PROCEDURE

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

Silver Diamine Fluoride(Control); Silver Diamine Fluoride+Potassium Iodide+Led Light

Eligibility Criteria

• Age: 4 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Primary molar teeth in which bone loss exceeds 1/3 of the roots.
• Primary molar teeth that have previously undergone root canal treatment or pulpotomy treatment.
• Presence of internal/external and root resorption in primary teeth to be treated.
• Root fracture, ankylosis or mobility in the primary teeth to be treated.

Sponsors & Collaborators

• Çanakkale Onsekiz Mart University: lead

Study Sites (1)

Canakkale Onsekiz Mart University

Çanakkale, Kepez, 17100, Turkey (Türkiye)

RECRUITING

Central Study Contacts

HİLAL ÖZTÜRK Research Assistant

CONTACT

00905312591404; hilalozturk98@gmail.com

Burak Çarıkçıoğlu Assoc. Prof.

CONTACT

carikcioglub@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: April 5, 2024
• First Posted: October 17, 2024
• Study Start: January 1, 2025
• Primary Completion: March 1, 2025
• Study Completion: January 1, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)