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

NCT ID: NCT06589622

Last Updated: 2024-09-19

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

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2025-12-01

Brief Summary

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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)

Detailed Description

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Conditions

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Decayed Primary Molars

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

Atraumatic restorative technique

Group Type EXPERIMENTAL

Atraumatic Restorative Treatment

Intervention Type PROCEDURE

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

Hall technique

Stainless steel crown placement without tooth preparation

Group Type EXPERIMENTAL

Hall technique

Intervention Type PROCEDURE

Crown placement without tooth preparation

Interventions

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Atraumatic Restorative Treatment

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

Intervention Type PROCEDURE

Hall technique

Crown placement without tooth preparation

Intervention Type PROCEDURE

Eligibility Criteria

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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.
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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Norhan ahmed ibrahim ismail

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cairo university

Cairo, , Egypt

Site Status

Countries

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Egypt

Facility Contacts

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Cairo univeristy Faculty of dentistry

Role: primary

00201002159535

Other Identifiers

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ART vs Hall technique

Identifier Type: -

Identifier Source: org_study_id

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