Comparing Hall vs Conventional Technique in Placing Preformed Metal Crowns From Sudan

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

COMPLETED

Clinical Phase

NA

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-01

Study Completion Date

2018-05-01

Brief Summary

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Preformed metal crowns (PMCs) have high success rates in restoring primary molars in children but they were not generally used by dentists, especially in developing countries due to its demand of high clinical skills with the conventional technique (CT). The biological approach, Hall technique (HT), requires less training and can be placed by less experienced dental operators including therapists. Previous studies were mainly carried out in developed countries. The aims were to investigate and compare the efficacies and cost-effectiveness of PMCs placed by these two techniques.

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Detailed Description

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A prospective randomised control trial design was used. The study was carried out in a dental practice in Sudan, an under-developed country with lower social economic group. Children between 5-8 years were invited and selected if they met the inclusion criteria. Only those who had 1-2 carious primary molars needing PMCs were randomised. The PMCs were placed by a dentist in the CT arm and by a therapist in the HT arm. The children were follow up every 6 months up to 2 years. The demographic details, periodontal health, occlusion, children anxieties, and procedure time were recorded. The Kaplan-Meier survival rates for each arm were calculated. The incremental cost effectiveness ratio (ICER) was calculated using the results and the local salaries

Conditions

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Caries, Dental

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Controlled randomized clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hall Technique

The intervention involves removal from the primary molar and a preformed metal crown is placed using glass ionomer. The subject is then asked to bite until crown is seated. No occlusal adjustment is carried out.

Group Type EXPERIMENTAL

Hall Technique PMC

Intervention Type PROCEDURE

Hall Technique primary fitted crowns to restore carious primary molars

Conventional Technique

The procedure involves administering local anesthetic and the intervention involves remoal of caries from the affected primary molar. The tooth is then reshaped and contoured to to enable a preformed metal crown placement. Occlusal and marginal fit is improved by crimping the metal crown to improve fit. The preformed metal crown is cemented with glass ionomer restorative material and occlusion finally checked. The subject is then asked to bite on a cotton roll for two minutes until the cement has set.

Group Type OTHER

Hall Technique PMC

Intervention Type PROCEDURE

Hall Technique primary fitted crowns to restore carious primary molars

Interventions

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Hall Technique PMC

Hall Technique primary fitted crowns to restore carious primary molars

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Healthy children with Class I or class II carious primary molars

Exclusion Criteria

* Had a compromised medical history
* Were pre- or un-cooperative to have clinical examinations
* Lived in remote villages and were unlikely to return for follow-up
* Had teeth with pain or sepsis
* Had teeth with caries extended in pulp either from clinical or radiographic examinations

Minimum Eligible Age

5 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes