Management of Occlusal Dentinal Caries in Deciduous Molars

NCT ID: NCT03552835

Last Updated: 2019-01-10

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-30

Study Completion Date

2018-12-10

Brief Summary

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This study evaluated and compared the efficacy of no caries removal and sealing with a well-adapted and crimped stainless steel crown verses selective caries removal upto soft dentin and upto firm dentin in healing and/or preventing progression of moderate to deep occlusal dentinal caries.

Detailed Description

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Dental caries is a complex multifactorial disease and is one of the most prevalent diseases throughout history. It can cost a lot of money to treat and causes infection, pain and the loss of teeth. Choices for managing a carious lesion cover a spectrum of options-from complete surgical excision, where no part of the visible carious tissue is left in the tooth before a restoration is placed, to the opposite extreme, where none of the carious tissue is removed and noninvasive methods are used to prevent progression of the lesion. Thus, this study compared efficacy of no caries removal and sealing the entire lesion verses partial selective caries removal to soft and to firm dentin in healing and/or preventing progression of moderate to deep occlusal dentinal caries in previously unrestored teeth by clinical and radiographic analysis in 4-7 year old children.

Conditions

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Caries, Dental

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

occlusal dentinal caries were managed by either partial caries removal upto soft dentin or partial caries removal upto firm dentin or no caries removal and were compared
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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no caries removal

mandibular occlusal caries were treated with placement of stainless steel crown with no caries removal

Group Type EXPERIMENTAL

no caries removal

Intervention Type PROCEDURE

occlusal caries were treated with no caries removal and placement of stainless steel crown

partial caries removal upto soft dentin

mandibular occlusal caries were treated by partial caries removal upto soft dentin

Group Type EXPERIMENTAL

partial caries removal upto soft dentin

Intervention Type PROCEDURE

occlusal caries were treated by partial caries removal upto soft dentin followed by Glass Ionomer Cement placement as a base and composite restoration

partial caries removal upto firm dentin

mandibular occlusal caries were treated by partial caries removal upto firm dentin

Group Type EXPERIMENTAL

partial caries removal upto firm dentin

Intervention Type PROCEDURE

occlusal caries were treated by partial caries removal upto firm dentin followed by Glass Ionomer Cement placement as a base and composite restoration

Interventions

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no caries removal

occlusal caries were treated with no caries removal and placement of stainless steel crown

Intervention Type PROCEDURE

partial caries removal upto soft dentin

occlusal caries were treated by partial caries removal upto soft dentin followed by Glass Ionomer Cement placement as a base and composite restoration

Intervention Type PROCEDURE

partial caries removal upto firm dentin

occlusal caries were treated by partial caries removal upto firm dentin followed by Glass Ionomer Cement placement as a base and composite restoration

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Children in the age group of 4 - 7 years
* Previously untreated first and second mandibular deciduous molars with moderate to deep occlusal caries i.e. caries involving middle 1/3rd to pulpal 1/3rd of dentin
* No root resorption or physiologic resorption not exceeding 2/3rd of the root length
* Children having positive and definitely positive behavior

Exclusion Criteria

* Children with special health care needs
* Children with dental crowding limiting the child's ability to maintain oral hygiene
* Teeth with clinical and/or radiological signs or symptoms of non- vitality
* Teeth with clinical and radiological signs or symptoms of irreversible pulpitis or dental abscess (Pain, mobility, tenderness to percussion, draining sinus, pulp polyp, furcal or periapical radiolucency, root resorption)
* Mobility of the tooth
* Pathologic root resorption
* Physiologic root resorption exceeding 2/3rd of root length in preoperative x-ray
Minimum Eligible Age

4 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sneha D. Suwarnkar

OTHER

Sponsor Role lead

Responsible Party

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Sneha D. Suwarnkar

Principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Sneha D Suwarnkar, MDS

Role: PRINCIPAL_INVESTIGATOR

Saraswati Dhanwantari Dental College and Hospital, Parbhani

Locations

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Dr Sneha D Suwarnkar

Parbhani, Maharashtra, India

Site Status

Countries

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India

Other Identifiers

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SarswatiDhanwantari

Identifier Type: -

Identifier Source: org_study_id

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