Management of Occlusal Dentinal Caries in Deciduous Molars (MOD)

January 8, 2019 updated by: Sneha D. Suwarnkar

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Maharashtra
      • Parbhani, Maharashtra, India, 431401
        • Dr Sneha D Suwarnkar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 7 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: no caries removal
mandibular occlusal caries were treated with placement of stainless steel crown with no caries removal
Procedure: no caries removal
occlusal caries were treated with no caries removal and placement of stainless steel crown
Experimental: partial caries removal upto soft dentin
mandibular occlusal caries were treated by partial caries removal upto soft dentin
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
Experimental: partial caries removal upto firm dentin
mandibular occlusal caries were treated by partial caries removal upto firm dentin
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sneha D. Suwarnkar

Investigators

  • Principal Investigator: Sneha D Suwarnkar, MDS, Saraswati Dhanwantari Dental College and Hospital, Parbhani

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2017

Primary Completion (Actual)

November 30, 2018

Study Completion (Actual)

December 10, 2018

Study Registration Dates

First Submitted

May 30, 2018

First Submitted That Met QC Criteria

May 30, 2018

First Posted (Actual)

June 12, 2018

Study Record Updates

Last Update Posted (Actual)

January 10, 2019

Last Update Submitted That Met QC Criteria

January 8, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SarswatiDhanwantari

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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