Management of Occlusal Caries Using Silver Modified Atraumatic Restorative Treatment Versus Atraumatic Restorative Treatment

Phase 2

Completed

• Conditions: Occlusal Caries
• Interventions: Drug: Silver modified atraumatic restorative treatment; Other: Atraumatic restorative treatment

• Registration Number: NCT04354636
• Lead Sponsor: Cairo University

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

Detailed Description

Aim of the study:

To evaluate the clinical and radiographic outcomes after the use of silver modified atraumatic restorative treatment versus atraumatic restorative treatment in the management of occlusal caries in primary molars in preschool children.

PICO:

Population:

Preschool children (4-6 years) with occlusal caries in second primary molars.

Intervention:

Silver modified atraumatic restorative treatment

Comparator/Control:

Atraumatic restorative treatment.

Outcomes:

Pain (provoked or spontaneous) OHRQoL(oral health related to quality of life) Parental esthetic perception Failure of restoration Caries density in radiograph

Time:

3, 6 and 12 months

Study design:

A randomized clinical trial

Study Timeline

• Study First Submitted: 2020-04-13
• Study First Submitted QC: 2020-04-20
• Study First Posted: 2020-04-21
• Study Start: 2021-09-01
• Primary Completion: 2022-10-03
• Study Completion: 2023-10-11
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-28
• Last Update Posted: 2024-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• • 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

Exclusion Criteria

• • Uncooperative children or parents

  • Children with systemic diseases
  • Children with previous allergies to any of the used materials

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Silver modified atraumatic restorative treatment	Silver modified atraumatic restorative treatment	Using silver diamine fluoride incorporated with atraumatic restorative treatment
Atraumatic restorative treatment	Atraumatic restorative treatment	Using atraumatic restorative treatment without the application of silver diamine fluoride

Primary Outcome Measures

Name	Time	Method
Questioning parent about whether the child have pain between follow up intervals (provoked or spontaneous)	12 months	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)

Secondary Outcome Measures

Name	Time	Method
OHRQoL(oral health related to quality of life)	3 months	The Early Childhood Oral Health Impact Scale (A-ECOHIS) Score 0-52. There will be 13 questions each question with a score 0-5 where 0 = excellent, 1=very good, 2=good, 3=fair , 4=poor and 5= unknown so the less the score the better is the oral health related to quality of life.
Questioning parents about their aesthetic perception	3 months	Parent reported (parent is asked whether he/she is accepting the tooth appearance or not) Outcome will be binary (yes/no)
ART assessment criteria (Codes 00-90)	12 months	Failure of restoration according to the code in the ART assessment criteria (Codes 00-90).; Code 00 or 10 are considered successful, codes 11-40 are classified as failures, and codes 50-90 are assigned in case the tooth was unavailable for evaluation
Caries density in radiograph	12 months	Pixel grey value

Trial Locations

Locations (1)

Faculty's pediatric dentiatry clinic; 🇪🇬 Cairo, Gizq, Egypt