Assessment of Stainless Stain Crowns Placed Using the Hall Technique and Traditional Technique

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2024-12-31

Brief Summary

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The purpose of this study is to evaluate and compare the clinical performance of Stainless Stain Crowns Placed Using the Hall Technique and Traditional Technique

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Detailed Description

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Stainless Stain Crowns (SSCs) will be placed on two primary molar teeth with proximal caries, in a split mouth design. 200 patients will be included in the study. The teeth will be randomized into two groups according to the technique.

Group 1: SSCs that will be placed using Traditional Technique Group 2: SSCs that will be placed using Hall Technique The cooperation of the child during the procedure will be assessed with Frankl scale. The crowns will be evaluated at baseline and 1., 6., 12., 18., 24. months. Radiographical evaluations will be at 6.,12. and 24. months. The data will be analysed statistically using chi square test and Log-Rank test and the Kaplan-Meier survival method will be used to estimate survival percentages.

Conditions

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Primary Teeth Dental Caries Dentin, Carious

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Hall technique

SSCs placed on primary teeth using Hall technique

Group Type EXPERIMENTAL

Hall technique

Intervention Type DEVICE

Metal Stainless stain crown placed with Hall technique

Traditional technique

SSCs placed on primary teeth using Traditional technique

Group Type ACTIVE_COMPARATOR

Traditional technique

Intervention Type DEVICE

Metal Stainless stain crown placed with Traditional technique

Interventions

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Hall technique

Metal Stainless stain crown placed with Hall technique

Intervention Type DEVICE

Traditional technique

Metal Stainless stain crown placed with Traditional technique

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients and parents of the patients who accept to participate and sign the informed consent
* Patients who have two first and/or second primary molars with caries affecting at least two surfaces
* Patients who are cooperative for the dental procedure

Exclusion Criteria

* Patients and parents of the patients who does not accept to participate and sign the informed consent
* Teeth that are previously restored
* Patients with a systemic disease,
* Patients who have orthodontic treatment
* Teeth which have a short period of time for succedaneous teeth to erupt
* Teeth which need vital or non-vital endodontic treatment
* Patients and/or parents who does not accept the esthetic appearance of SSC

Minimum Eligible Age

4 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes