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

Cairo University50 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Occlusal Caries

Interventions

Silver modified atraumatic restorative treatmentDRUG

Silver diamine fluoride that will be applied during atraumatic restorative treatment

Atraumatic restorative treatmentOTHER

Using atraumatic restorative treatment without applying silver diamine fluoride

Eligibility

Sex: ALLMin age: 4 YearsMax age: 6 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Faculty's pediatric dentiatry clinic

Cairo, Gizq, Egypt

Outcomes

Primary Outcomes

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)

Time frame: 12 months

Secondary Outcomes

OHRQoL(oral health related to quality of life)

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.

Time frame: 3 months

Questioning parents about their aesthetic perception

Parent reported (parent is asked whether he/she is accepting the tooth appearance or not) Outcome will be binary (yes/no)

Time frame: 3 months

ART assessment criteria (Codes 00-90)

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

Time frame: 12 months

Caries density in radiograph

Pixel grey value

Time frame: 12 months

Data from ClinicalTrials.gov

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