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Not yet recruiting NCT06594770

Time of Treatment in HALL Technique Vs ART

No phase Interventional Healthy

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: Healthy. 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
Center list to be confirmed — check the primary protocol.
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

Time of Treatment of Hall Technique Versus Atraumatic Restorative Technique in the Management of Carious Primary Molars: a Randomized Clinical Trial

Overview

The goal of this clinical trial is to assess the time of treatment of Hall Technique versus Atraumatic Restorative Technique in the management of carious primary molars. The main questions it aims to answer are: * Does the Hall Technique provide a faster and pain-free treatment compared to ART? * How do the outcomes of both techniques impact children's acceptance and behavior? Researchers will compare the Hall Technique, which uses preformed metal crowns without caries removal, to Atraumatic Restorative Treatment, which uses hand instruments to selectively remove carious tissue. Participants will: * Receive treatment using either the Hall Technique or ART in a single session. * Attend follow-up visits to monitor the effectiveness and acceptance of the treatment. * Complete assessments on their experience and comfort during and after the procedure.

Interventions

  • Procedure Atraumatic Restorative Treatment
    A sharp excavator will be used to remove soft demineralized carious tissue from the patient\'s primary molar 2-The molar will then be restored with capsulated Glass Ionomer in accordance to ART procedure. 3-Each capsule will be mixed for ten seconds and used for restoring teeth isolated by cotton rolls. 4-After the cement is cured, excess material will be removed with an excavator and a carver. 5-The occlusion will be tested for interferences with carbon paper. A layer of varnish coat wil
  • Procedure Hall technique
    The procedure involves assessing the occlusion, contact points, and tooth shape. If contact points are present, orthodontic separators will be placed between the primary molars to create space for crown fitting, with the child seated upright to maintain airway safety. After 3 to 5 days, the separators will be removed, and loose plaque and debris will be cleared. The correct crown size will be selected, ensuring it doesn't impinge on adjacent teeth, and will be filled with glass ionomer cement.

Primary outcome measures

  • time of treatment [Time frame: during the procedure]
Secondary outcome measures (4)
  • Postoperative Pain and discomfort [Time frame: immediately after the procedure , 3month ,6 month and 12 month]
  • Child behavior [Time frame: during the procedure]
  • Canine overbite: HT [Time frame: preoperatively , immediately after the procedure , 3 month , 6 month, 12 month]
  • Child anxiety [Time frame: during the procedure]

Eligibility criteria

Inclusion criteria

  • Age: From 4 to 6 years.
  • Caries in primary molars within enamel/dentin with vital pulp.
  • Healthy children.
  • Cooperative children

Exclusion criteria

  • Presence of signs and symptoms of necrosis.
  • 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

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06594770 · Hall technique VS ART

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗