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Completed

NCT Number: NCT03552835

Management of Occlusal Dentinal Caries in Deciduous Molars

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.

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Key information

Age range

4 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr Sneha D Suwarnkar

Parbhani, Maharashtra, 431401, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

no caries removal

Procedure

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

partial caries removal upto soft dentin

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

Procedure

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

Primary outcomes

  1. correlation between caries activity and efficacy of three groups

    Time frame: 12 months

    to check for caries activity and efficacy of three groups i.e. no caries removal, partial caries removal upto soft dentin and partial caries removal upto firm dentin

Sponsors and collaborators

Lead sponsor

Sneha D. Suwarnkar

Other

Registry information

Official study title

Management of Occlusal Dentinal Caries in Deciduous Molars- A Clinical and Radiographic Evaluation of Three Approaches

Acronym: MOD

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 12, 2018
Registry last updated
Jan 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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