NCT04354636

Brief Summary

Silver modified atraumatic restorative treatment (intervention) or atraumatic restorative treatment (Control) will be used to manage occlusal caries in preschool children then the molars will be evaluated at the interval of 3,6 and 12 months clinically and 6 and 12 months radiographically

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 21, 2020

Completed
1.4 years until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2023

Completed
Last Updated

December 30, 2024

Status Verified

December 1, 2024

Enrollment Period

1.1 years

First QC Date

April 13, 2020

Last Update Submit

December 28, 2024

Conditions

Occlusal Caries

Outcome Measures

Primary Outcomes (1)

  • Questioning parent about whether the child have pain between follow up intervals (provoked or spontaneous)

    Pain reported-Pain history that occurs after treatment at any point (will be recorded at the follow up intervals) Outcome will be binary (yes/no)

    12 months

Secondary Outcomes (4)

  • OHRQoL(oral health related to quality of life)

    3 months

  • Questioning parents about their aesthetic perception

    3 months

  • ART assessment criteria (Codes 00-90)

    12 months

  • Caries density in radiograph

    12 months

Study Arms (2)

Silver modified atraumatic restorative treatment

EXPERIMENTAL

Using silver diamine fluoride incorporated with atraumatic restorative treatment

Drug: Silver modified atraumatic restorative treatment

Atraumatic restorative treatment

ACTIVE COMPARATOR

Using atraumatic restorative treatment without the application of silver diamine fluoride

Other: Atraumatic restorative treatment

Interventions

Silver modified atraumatic restorative treatmentDRUG

Silver diamine fluoride that will be applied during atraumatic restorative treatment

Silver modified atraumatic restorative treatment
Atraumatic restorative treatmentOTHER

Using atraumatic restorative treatment without applying silver diamine fluoride

Atraumatic restorative treatment

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Patient and parent cooperation and compliance.
  • Children aged 4 - 6 years
  • Second primary molars with occlusal caries.
  • No clinical signs and symptoms of pulp involvement
  • No radiographic abnormalities

You may not qualify if:

  • Uncooperative children or parents
  • Children with systemic diseases
  • Children with previous allergies to any of the used materials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty's pediatric dentiatry clinic

Cairo, Gizq, Egypt

Location

Related Publications (4)

  • Vollu AL, Rodrigues GF, Rougemount Teixeira RV, Cruz LR, Dos Santos Massa G, de Lima Moreira JP, Luiz RR, Barja-Fidalgo F, Fonseca-Goncalves A. Efficacy of 30% silver diamine fluoride compared to atraumatic restorative treatment on dentine caries arrestment in primary molars of preschool children: A 12-months parallel randomized controlled clinical trial. J Dent. 2019 Sep;88:103165. doi: 10.1016/j.jdent.2019.07.003. Epub 2019 Jul 4.

    PMID: 31279925BACKGROUND

  • Saber AM, El-Housseiny AA, Alamoudi NM. Atraumatic Restorative Treatment and Interim Therapeutic Restoration: A Review of the Literature. Dent J (Basel). 2019 Mar 7;7(1):28. doi: 10.3390/dj7010028.

    PMID: 30866534BACKGROUND

  • Oliveira BH, Rajendra A, Veitz-Keenan A, Niederman R. The Effect of Silver Diamine Fluoride in Preventing Caries in the Primary Dentition: A Systematic Review and Meta-Analysis. Caries Res. 2019;53(1):24-32. doi: 10.1159/000488686. Epub 2018 Jun 6.

    PMID: 29874642BACKGROUND

  • van Gemert-Schriks MC, van Amerongen WE, ten Cate JM, Aartman IH. Three-year survival of single- and two-surface ART restorations in a high-caries child population. Clin Oral Investig. 2007 Dec;11(4):337-43. doi: 10.1007/s00784-007-0138-8. Epub 2007 Aug 21.

    PMID: 17710452BACKGROUND

MeSH Terms

Interventions

Dental Atraumatic Restorative Treatment

Intervention Hierarchy (Ancestors)

Dentistry

Study Officials

  • Sherif B El Tawil, Professor

    Pediatric Dentistry & Dental Public Health Faculty of Dentistry , Cairo university

    STUDY DIRECTOR

  • Dalia M Moheb, Associate professor

    Pediatric Dentistry & Dental Public Health Faculty of Dentistry , Cairo university

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 13, 2020

First Posted

April 21, 2020

Study Start

September 1, 2021

Primary Completion

October 3, 2022

Study Completion

October 11, 2023

Last Updated

December 30, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)