Alternative Treatment of Deep Carious Lesions Based on Biological Evidences

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2015-03-31

Brief Summary

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The purpose of this study is to evaluate the success rate of alternative treatment of deep carious lesions in asymptomatic primary teeth with no clinical nor radiographic signs of pulpal inflammation. The treatment includes leaving a thin layer of caries that is present near the pulp chamber and includes liner placement and tooth sealing. This alternative treatment is to be compared with the treatment provided today to these teeth, which includes complete removal of caries and probably includes pulpotomy and wide preparation of the tooth. The study also evaluates the cost-effectiveness of both methods of treatment of deep carious lesions.

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Detailed Description

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The treatment provided today for deep carious lesions in deciduous teeth is complete removal of the soft caries, that can lead to a wide preparation and need of tooth pulpotomy if the caries reaches to the pulp chamber, even if the tooth is asymptomatic and shows no signs of pulpal inflammation (neither clinically nor radiographically). According to a number of recent evidence based researches, and only in selected cases, dentists were able to preserve the vitality of the pulp without complete removal of the caries present near the pulp chamber. A thin layer of caries near the pulp chamber is left, and a liner is placed (conservative treatment). The carious process is stopped when the tooth is sealed, and thus the tooth is saved without engaging with pulpotomy and wide preparation of the tooth. The purpose of this study is to evaluate the success rate of the conservative treatment of deep carious lesions versus the treatment provided today that includes complete removal of caries and probably includes pulpotomy and wide preparation of the tooth. The study also evaluates the cost-effectiveness of both methods of treatment of deep carious lesions.

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

SINGLE

Investigators

Study Groups

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Complete caries removal

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Incomplete caries removal

Test group

Group Type OTHER

Incomplete caries removal in primary teeth

Intervention Type OTHER

Comparison between the success rate and cost-effectiveness of complete caries removal in treatment of deep carious lesions that might include wide preparations and involve pulpotomy versus incomplete removal of caries and avoiding pulp treatment.

Interventions

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Incomplete caries removal in primary teeth

Comparison between the success rate and cost-effectiveness of complete caries removal in treatment of deep carious lesions that might include wide preparations and involve pulpotomy versus incomplete removal of caries and avoiding pulp treatment.

Intervention Type OTHER

Other Intervention Names

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Indirect pulp capping

Eligibility Criteria

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Inclusion Criteria

* Healthy children
* Patient's age is 5-8 years old at the time of the treatment
* Primary molars presenting with deep carious lesions
* Carious lesion reaching the inner half of the dentin,with absence of periapical or interradicular alterations as detected by radiographic examination.
* Absence of spontaneous pain