Comparison of Silver Modified and Conventional Atraumatic Restorative Treatment Modalities

NCT03881020 | Completed Phase 4 FDA Drug

• 1 other identifier: PED 18-3D
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a randomized controlled trial aiming to compare the effectiveness of Silver modified atraumatic restorative technique and (SMART) and conventional atraumatic restorative technique (ART) regarding their caries arresting properties in primary molars, patient acceptance and cost effectiveness.

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (1)

• Arresting carious lesion progression and restoration survival

  Restorations will be assessed for clinical success and caries arrest in terms of presence of sensitivity, marginal integrity, restoration survival and recurrent caries using United States Public Health Services (USPHS) criteria. Restorations with good color match, good marginal adaptation, no sensitivity and no evidence of caries will be given score alfa (A). Restorations with slight discoloration, slight discontinuity and diminishing sensitivity will be given score bravo (B). Restorations with unacceptable color, exposed dentin, constant sensitivity and evidence of caries will be given score charlie (C). Restorations fractured or lost will be scored as delta (D).

  1 year

Secondary Outcomes (1)

• Patient acceptance

  will be recorded immediately after the procedure

Other Outcomes (1)

• cost effectiveness

  1 year

Study Arms (2)

SMART

EXPERIMENTAL

Silver modified atraumatic restorative treatment group in which advantage Arrest Silver diamine Fluoride 38% (Elevate oral Care, USA ) will be applied to carious molars then teeth will be restored with GC Fuji IX GP® FAST FAST Packable Posterior Restorative glass ionomer fillings (GC corporation, Tokyo, Japan)

Drug: Silver diamine Fluoride 38%

Conventional ART

ACTIVE COMPARATOR

Conventional atraumatic restorative treatment group in which a sharp excavator will be used to remove caries from carious molars then teeth will be restored with GC Fuji IX GP® FAST FAST Packable Posterior Restorative glass ionomer fillings (GC corporation, Tokyo, Japan)

Procedure: Conventional atraumatic restorative treatment

Interventions

Silver diamine Fluoride 38% DRUG

In the intervention group 38% Silver Diamine Fluoride will be applied to the surface of the isolated lesion for a period of 1 minute followed by glass ionomer restoration at the same visit.

Also known as: Advantage Arrest Silver diamine Fluoride 38%

SMART

Conventional atraumatic restorative treatment PROCEDURE

In the active comparator group caries will be removed from primary molars using sharp excavators then teeth will be restored using glass ionomer filling material at the same visit.

Also known as: ART

Conventional ART

Eligibility Criteria

• Age: 5 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Medically free children.
• Clinical examination revealing at least one second primary molar with single surface active dentine carious lesions.
• Children who agreed to participate and whose parents signed an informed consent.
• Cooperative or potentially cooperative children according to Wright Classification

You may not qualify if:

• Children who have known allergies to silver products.
• Children with special health care needs or any medical conditions.
• Children with designated molars having more than one third of their crown missing.
• Children with designated molars showing signs of pulpal pathology such as spontaneous pain, presence of an abscess or sinus or mobility.
• Children with designated molars having an existing restoration.
• Children with designated molars having deep carious lesions with close proximity to the pulp.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Dentistry Ain Shams University

Cairo, Egypt

Location

Related Publications (1)

• Aly AAM, Aziz AMA, Elghazawy RK, El Fadl RKA. Survival Analysis and Cost Effectiveness of Silver Modified Atraumatic Restorative Treatment (SMART) and ART Occlusal Restorations in Primary Molars: a randomized controlled trial. J Dent. 2023 Jan;128:104379. doi: 10.1016/j.jdent.2022.104379. Epub 2022 Nov 29.

  PMID: 36460236 DERIVED

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Abla Ah Aly, A. Lecturer

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer at Faculty of Oral and Dental Medicine Future University in Egypt

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: March 19, 2019
• Study Start: August 3, 2020
• Primary Completion: November 3, 2021
• Study Completion: December 30, 2021
• Last Updated: February 23, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)