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Not yet recruiting NCT06589622

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

No phase Interventional Decayed Primary Molars

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Atraumatic Restorative Treatment, Hall technique.
Who it may be relevant to
Registry conditions: Decayed Primary Molars. Basic parameters: 4 years — 6 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Major Failures of Hall Technique Versus Atraumatic Restorative Technique in the Management of Carious Primary Molars: Randomized Clinical Trial

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)

Interventions

  • Procedure Atraumatic Restorative Treatment
    Caries excavation with hand instruments only and restoration with Glass ionomer filling
  • Procedure Hall technique
    Crown placement without tooth preparation

Primary outcome measures

  • Major failure [Time frame: 1 year follow up]
Secondary outcome measures (4)
  • Canine overbite [Time frame: 3 months, 6 months and 1 year follow up]
  • Postoperative pain and discomfort [Time frame: Immediately postoperative]
  • Child anxiety [Time frame: Intraoperative]
  • Child behavior [Time frame: Intraoperative]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Cairo university — Cairo

Identifiers

NCT: NCT06589622 · ART vs Hall technique

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗