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Atraumatic Versus Silver-Modified Atraumatic Restorative Treatment in Primary Molars

NCT07023939 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-06-17

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate and compare the short-term effectiveness of two minimally invasive treatments-Atraumatic Restorative Treatment (ART) and Silver-Modified Atraumatic Restorative Treatment (SMART)-in managing dentine caries lesions in the primary molars of children aged 3 to 7 years with Early Childhood Caries (ECC). The main questions it aims to answer are:

* Which treatment method (ART or SMART) results in higher clinical success after six months?
* How do ART and SMART treatments affect the Oral Health-Related Quality of Life (OHRQoL) of the children? The researcher will compare teeth restored using ART with those treated using SMART (which includes the application of silver diamine fluoride before restoration) to see if one approach leads to better restoration outcomes and to assess how these restorations will impact the quality of life.

Participants will:

* Receive both types of treatments in different teeth (split-mouth design).
* Undergo clinical evaluation of the treated teeth at baseline and six months to assess success based on restoration retention, integrity, and absence of secondary caries.
* Have their parents complete a quality-of-life questionnaire (A-ECOHIS) at the start and at the six-month follow-up.

Conditions

  • Dental Caries
  • Dental Caries in Children

Interventions

DRUG

ART: Atraumatic restorative treatment, SMART: Silver-Modified Atraumatic Restorative Treatment

ART Group: Selective caries removal was done using hand instruments-carious dentin was excavated from the axial walls with a spoon excavator, and unsupported enamel was carefully removed using a hatchet. On the pulpal floor, only soft, completely demineralized dentin was removed until firm dentin was reached. SMART Group: the surrounding gingival tissues and lips were protected with petroleum jelly to avoid staining and irritation (2) ) one drop of SDF (Advantage Arrest ™, Elevate Oral Care, USA) was placed into a disposable dish, (4) SDF was applied with a bended micro-sponge directly to the affected tooth surfaces for minimum of 60 seconds, (3) excess was blotted with a cotton pellet, (4)and the area was air-dried while maintaining isolation for up to three minutes.

Sponsors & Collaborators

  • Beirut Arab University

    lead OTHER

Principal Investigators

  • Dr.Ahmad Tarabaih, Assoc.Prof · Department of Pediatric Dentistry, Beirut Arab university

  • Dr.Ahmad Holiel, Assis.Prof · Department of Esthetic and Restorative Dentistry, Beirut Arab University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
3 Years
Max Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-02
Primary Completion
2024-01-16
Completion
2024-12-10
FDA Drug
Yes

Countries

  • Lebanon

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07023939 on ClinicalTrials.gov