Comparison of the Treatment Outcomes of the Conventional Stainless Steel Crown Restorations and the Hall Technique in the Treatment of Carious Primary Molars

NCT ID: NCT06597669

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

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-04

Study Completion Date

2026-05-31

Brief Summary

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Stainless steel crowns have shown high success in restoring carious primary molars over a longer period of time than conventional restorations. This study aims to evaluate the treatment effectiveness of conventional SSCs restoration and Hall technique in treating carious primary molars

Detailed Description

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Conditions

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Caries,Dental

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Conventional Technique

A stainless steel crown will place on a carious primary molar after preparation

Group Type EXPERIMENTAL

Placement of stainless steel crowns on primary molars

Intervention Type PROCEDURE

Preformed metal crowns have been placed to treat caries in primary molars

Hall technique

A stainless steel crown will place on a carious primary molar without local anesthesia caries removal or any preparation

Group Type EXPERIMENTAL

Placement of stainless steel crowns on primary molars

Intervention Type PROCEDURE

Preformed metal crowns have been placed to treat caries in primary molars

Interventions

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Placement of stainless steel crowns on primary molars

Preformed metal crowns have been placed to treat caries in primary molars

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Agree and voluntarily participate in the research (with the patient's parent/guardian consent for participation)
2. Children have a primary molar with at least 2 carious lesions corresponding to International Caries Detection and Assessment System (ICDAS) scores 4 or at least 1 carious lesion corresponding to ICDAS scores 5 and 6.

Exclusion Criteria

1. Children with systemic diseases such as immunodeficiency, cardiovascular disease, or bleeding disorders.
2. Children are allergic to nickel and resin.
3. Children unable to return for recall visits.
4. Primary molar has signs of pulpal/periapical diseases (irreversible pulpitis, pulp necrosis, loosening, fistula, or abscess).
5. Children are undergoing orthodontic treatment with fixed or removable appliances.
Minimum Eligible Age

3 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hue University of Medicine and Pharmacy

OTHER

Sponsor Role lead

Responsible Party

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Le Van Nhat Thang

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hue University of Medicine and Pharmacy

Huế, Thừa Thiên Huế Province, Vietnam

Site Status RECRUITING

Countries

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Vietnam

Facility Contacts

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Thanh Thao Nguyen, MD, PhD

Role: primary

+84234 3822 173

Van Nhat Thang Le, DDS, PhD

Role: backup

Other Identifiers

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H2024/097

Identifier Type: -

Identifier Source: org_study_id

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