Time of Treatment in HALL Technique Vs ART

NCT ID: NCT06594770

Last Updated: 2024-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-31

Study Completion Date

2025-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ART

Group Type EXPERIMENTAL

Atraumatic Restorative Treatment

Intervention Type 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

Group Type ACTIVE_COMPARATOR

Hall technique

Intervention Type 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.

Interventions

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

Intervention Type 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. 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

4 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Doaa Mohamed Khalil

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Doaa mohamed mustafa

Role: CONTACT

00201550150989

Other Identifiers

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Hall technique VS ART

Identifier Type: -

Identifier Source: org_study_id

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