Atraumatic Versus Silver-Modified Atraumatic Restorative Treatment in Primary Molars

NCT07023939 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: 2022-H-011-D-M-0489
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Early Childhood caries; SilverDiamine flouride; Glass Ionomer Cement; Minimal Intervention Dentistry

Outcome Measures

Primary Outcomes (1)

• primary outcome : Success rate of restorations assessed by Modified ART Criteria

  The proportion of restorations that meet criteria for success based on Modified ART CRITERIA evaluation UNIT OF MEASURE: % OF restorations rated successful

  6 months post-treatment

Secondary Outcomes (1)

• Change in Oral Health-Related Quality of Life (OHRQoL) assessed by Early Childhood Oral Health Impact Scale (ECOHIS) filled by parents

  Baseline and 6-month follow-up

Study Arms (2)

ART- Atraumatic Restorative Treatment

ACTIVE COMPARATOR

Children received Atraumatic Restorative Treatment (ART), which involved selective caries removal using hand instruments and restoration with high-viscosity glass ionomer cement. Carious dentin was excavated from the axial walls with a spoon excavator, unsupported enamel was removed with a hatchet, and only soft demineralized dentin on the pulpal floor was removed until firm dentin was reached.

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

SMART_Silver-Modified Atraumatic Restorative Treatment

EXPERIMENTAL

Children received Silver-Modified Atraumatic Restorative Treatment (SMART), which included the application of 38% silver diamine fluoride (SDF) followed by ART. Gingival tissues and lips were protected with petroleum jelly. One drop of SDF (Advantage Arrest™, Elevate Oral Care, USA) was placed into a disposable dish and applied to affected tooth surfaces using a bent micro-sponge for at least 60 seconds. Excess was blotted with a cotton pellet, and the area was air-dried under isolation for up to three minutes. ART was then completed using high-viscosity glass ionomer cement.

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

Interventions

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

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.

ART- Atraumatic Restorative Treatment; SMART_Silver-Modified Atraumatic Restorative Treatment

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Study Participants: Generally healthy children aged 3 to 7 years
• Behavior Rating (Frankel's Scale):
• Negative (Score 2) Positive (Score 3)
• Dental Condition: At least two bilateral asymptomatic decayed primary molars
• Caries Classification: based on International caries detection and assessment systemII I(CDAS II) Scores 4 \& 5 (Occlusal or occluso-proximal carious dentin lesions)

You may not qualify if:

• Children with systemic diseases/conditions (ASA Type I)
• Behavior Rating (Frankel's Scale) Definitely positive(Score 1) Definitely negative (Score 4).
• Teeth showing irreversible pulpitis or pulpal pathology (abscess, fistula, mobility)
• Teeth with very deep cavities or score 6 based on ICDAS II

Sponsors & Collaborators

• Beirut Arab University: lead

Study Sites (1)

Beirut arab University

Beirut, Lebanon

Location

Related Publications (1)

• Solh SK, Holiel AA, Tarabaih AS. Atraumatic Versus Silver-Modified Atraumatic Restorative Treatment in Primary Molars: A Randomized Clinical Trial on Minimally Invasive Caries Management and Oral Health-Related Quality of Life. Clin Exp Dent Res. 2026 Feb;12(1):e70299. doi: 10.1002/cre2.70299.

  PMID: 41632901 DERIVED

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Dr.Ahmad Tarabaih, Assoc.Prof

  Department of Pediatric Dentistry, Beirut Arab university

  STUDY DIRECTOR

• Dr.Ahmad Holiel, Assis.Prof

  Department of Esthetic and Restorative Dentistry, Beirut Arab University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The data analyst performing statistical evaluations was masked to group allocation during the initial analysis.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Instructor

Model Details: split mouth design

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: June 17, 2025
• Study Start: May 2, 2023
• Primary Completion: January 16, 2024
• Study Completion: December 10, 2024
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)