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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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06589622
Enrollment
64
Registered
2024-09-19
Start date
2024-10-01
Completion date
2025-12-01
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Decayed Primary Molars

Keywords

ART, Hall technique, decayed primary molars

Brief summary

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

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

PROCEDUREHall technique

Crown placement without tooth preparation

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
4 Years to 6 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Major failure1 year follow upIrreversible pulpitis, Dental abscess or fistula, Restoration loss, Tooth cannot be restored, Tooth fracture.

Secondary

MeasureTime frameDescription
Canine overbite3 months, 6 months and 1 year follow up
Postoperative pain and discomfortImmediately postoperativeFace 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
Child anxietyIntraoperativeVenham 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.
Child behaviorIntraoperativeVenham behavior rating scale Its a scale from 0-5 with 0 being total cooperation and 5 being total uncooperation and physical restraint is required.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026