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NCT Number: NCT06594770

Time of Treatment in HALL Technique Vs ART

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.

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Key information

Conditions

Healthy

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

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.
  • 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.

Treatment and study plan

Atraumatic Restorative Treatment

Procedure

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 will be applied to the surface and light-cured for 20 seconds .

Hall technique

Procedure

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. The child will be instructed to bite down for two minutes to ensure proper seating. Excess cement will be removed, and contacts will be flossed. Any initial occlusal discrepancies are expected to resolve within weeks.

Primary outcomes

  1. time of treatment

    Time frame: during the procedure

    Time will be measured from the start of the procedure till its end using digital chronometer as a device and minutes as a unit.

Secondary outcomes

  1. Postoperative Pain and discomfort

    Time frame: immediately after the procedure , 3month ,6 month and 12 month

    Immediately after the treatment, any pain and discomfort experienced by the child will be recorded using the Face Pain Scale - revised (FPS-R), which has six numbered faces from 0 to10 The (FPS-R). Each child will be asked to mark the face that reflects her or his experienced pain during the treatment. There is no pain visible on this face [indicating the face on the far left]. As you move from left to right, the faces get progressively more painful until you reach this one, which is incredibly painful [indicating the face on the far right]. The (FPS-R) faces will be scored as 0-2-4-6-8-10.

  2. Child behavior

    Time frame: during the procedure

    At the end of the treatment session, the dentist classifies the child's behavior during the treatment according to Venham Behavior Rating Scale is a reliable system for rating behavior of children in the dental setting. ratings will be scored as 0-1-2-3-4-5

  3. Canine overbite: HT

    Time frame: preoperatively , immediately after the procedure , 3 month , 6 month, 12 month

    the canine overbite will be measured only for the hall technique group. The canine overbite will be measured before the procedure using a Boley Gauge, either on the same side or the opposite side if the canine is missing. After assessing tooth shape and occlusion, a stainless-steel crown (SSC) will be partially seated on the tooth with glass ionomer cement. The child will bite on a cotton roll to fully seat the crown, after which excess cement will be removed, and the overbite will be recorded immediately after treatment.

  4. Child anxiety

    Time frame: during the procedure

    At the end of the treatment session, the dentist classifies the child's anxiety during the treatment according to Venham Anxiety Rating Scale is a reliable system for rating anxiety of children in the dental setting. ratings will be scored as 0-1-2-3-4-5

Study contacts

Contact information is provided by the study sponsor or research team.

Doaa mohamed mustafa

CONTACT

[email protected]

00201550150989

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Oct 15, 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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