Major Failure Rate Assessment of Atraumatic Restorative Techniques Versus Hall Technique in the Management of Decayed Primary Molars in Children Aged 4-6 Years Old

N/ANot Yet RecruitingNCT06589622

Cairo University64 enrolled

Overview

This study is designed to compare major failure rate between ART ( excavation of caries with hand instruments and placing glass ionomer restoration without the use of rotary instruments) versus hall technique ( placing a stainless steel crown on the decayed primary molar without prepartion or caries removal)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Decayed Primary Molars

Interventions

Atraumatic Restorative TreatmentPROCEDURE

Caries excavation with hand instruments only and restoration with Glass ionomer filling

Hall techniquePROCEDURE

Crown placement without tooth preparation

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria * Age: From 4 to 6 years. * Cooperative children * Children with no systemic disease, occlusal problems or bad habits. * Primary molars with vital pulp. * Class II Caries in primary molars within enamel/dentin. * Molars in occlusion with the antagonist tooth/teeth. * Teeth with no developmental anomalies. * Absence of spontaneous pain and tenderness to percussion. * Absence of any radiolucency in furcation and/or periradicular regions. * No pathological and internal/external resorption. Exclusion criteria: * Presence of signs and symptoms of necrosis (Fistula, abscess, mobility or furcation involvement). * Root caries. * History of Spontaneous pain.

Locations (1)

Cairo university

Cairo, Egypt

Outcomes

Primary Outcomes

Major failure

Irreversible pulpitis, Dental abscess or fistula, Restoration loss, Tooth cannot be restored, Tooth fracture.

Time frame: 1 year follow up

Secondary Outcomes

Canine overbite

Time frame: 3 months, 6 months and 1 year follow up

Postoperative pain and discomfort

Face pain scale-revised Its a self report measure of pain intenisty from 0 to 10 with 0 being least painful and 10 being most painful

Time frame: Immediately postoperative

Child anxiety

Venham anxiety rating scale is a scale from 0 to 5 assessing the anxiety of children in dental setting with 0 being most relaxed and smiling and 5 being most anxious and out of contact with the reality of the threat.

Time frame: Intraoperative

Child behavior

Venham behavior rating scale Its a scale from 0-5 with 0 being total cooperation and 5 being total uncooperation and physical restraint is required.

Time frame: Intraoperative

Data from ClinicalTrials.gov

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