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Management of Occlusal Dentinal Caries in Deciduous Molars (MOD)

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ClinicalTrials.gov Identifier: NCT03552835
Recruitment Status : Completed
First Posted : June 12, 2018
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Sneha D. Suwarnkar, Saraswati-Dhanwantari Dental College & Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Caries, Dental Procedure: no caries removal Procedure: partial caries removal upto soft dentin Procedure: partial caries removal upto firm dentin Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Management of Occlusal Dentinal Caries in Deciduous Molars- A Clinical and Radiographic Evaluation of Three Approaches
Actual Study Start Date : October 30, 2017
Actual Primary Completion Date : November 30, 2018
Actual Study Completion Date : December 10, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03552835


Locations
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India
Dr Sneha D Suwarnkar
Parbhani, Maharashtra, India, 431401
Sponsors and Collaborators
Sneha D. Suwarnkar
Investigators
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Principal Investigator: Sneha D Suwarnkar, MDS Saraswati Dhanwantari Dental College and Hospital, Parbhani

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Responsible Party: Sneha D. Suwarnkar, Principal investigator, Saraswati-Dhanwantari Dental College & Hospital
ClinicalTrials.gov Identifier: NCT03552835     History of Changes
Other Study ID Numbers: SarswatiDhanwantari
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sneha D. Suwarnkar, Saraswati-Dhanwantari Dental College & Hospital:
no caries removal
partial caries removal upto soft dentin
partial caries removal upto firm dentin
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Salicylic Acid
Anti-Infective Agents
Antifungal Agents
Keratolytic Agents
Dermatologic Agents