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NCT Number: 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

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)

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Key information

Conditions

Decayed Primary Molars

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Atraumatic Restorative Treatment

Procedure

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

Hall technique

Procedure

Crown placement without tooth preparation

Primary outcomes

  1. Major failure

    Time frame: 1 year follow up

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

Secondary outcomes

  1. Canine overbite

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

  2. Postoperative pain and discomfort

    Time frame: Immediately postoperative

    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

  3. Child anxiety

    Time frame: Intraoperative

    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.

  4. Child behavior

    Time frame: Intraoperative

    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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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