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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-6
SponsorCairo University

About this trial

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)

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age: From 4 to 6 years.

Cooperative children

Children with no systemic disease, occlusal problems or bad habits.

Primary molars with vital pulp.

Disqualifiers

Presence of signs and symptoms of necrosis (Fistula, abscess, mobility or furcation involvement).

Root caries.

History of Spontaneous pain.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Atraumatic Restorative Treatment

    Procedure/Surgery

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

  • Hall technique

    Procedure/Surgery

    Crown placement without tooth preparation

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: ARTExperimental treatment 1 intervention
Group B: Hall techniqueExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Major failure

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

Time frame
1 year follow up

Secondary outcomes

1

Canine overbite

Time frame
3 months, 6 months and 1 year follow up
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: