Back to resultsManagement of Occlusal Dentinal Caries in Deciduous Molars (MOD)
Primary Purpose
Caries, Dental
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
no caries removal
partial caries removal upto soft dentin
partial caries removal upto firm dentin
Sponsored by
About this trial
This is an interventional treatment trial for Caries, Dental focused on measuring no caries removal, partial caries removal upto soft dentin, partial caries removal upto firm dentin
Eligibility 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
Sites / Locations
- Dr Sneha D Suwarnkar
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
no caries removal
partial caries removal upto soft dentin
partial caries removal upto firm dentin
Arm Description
mandibular occlusal caries were treated with placement of stainless steel crown with no caries removal
mandibular occlusal caries were treated by partial caries removal upto soft dentin
mandibular occlusal caries were treated by partial caries removal upto firm dentin
Outcomes
Primary Outcome Measures
correlation between caries activity and efficacy of three groups
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03552835
Brief Title
Management of Occlusal Dentinal Caries in Deciduous Molars
Acronym
MOD
Official Title
Management of Occlusal Dentinal Caries in Deciduous Molars- A Clinical and Radiographic Evaluation of Three Approaches
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
October 30, 2017 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
December 10, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sneha D. Suwarnkar
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caries, Dental
Keywords
no caries removal, partial caries removal upto soft dentin, partial caries removal upto firm dentin
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
no caries removal
Arm Type
Experimental
Arm Description
mandibular occlusal caries were treated with placement of stainless steel crown with no caries removal
Arm Title
partial caries removal upto soft dentin
Arm Type
Experimental
Arm Description
mandibular occlusal caries were treated by partial caries removal upto soft dentin
Arm Title
partial caries removal upto firm dentin
Arm Type
Experimental
Arm Description
mandibular occlusal caries were treated by partial caries removal upto firm dentin
Intervention Type
Procedure
Intervention Name(s)
no caries removal
Intervention Description
occlusal caries were treated with no caries removal and placement of stainless steel crown
Intervention Type
Procedure
Intervention Name(s)
partial caries removal upto soft dentin
Intervention Description
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
Intervention Name(s)
partial caries removal upto firm dentin
Intervention Description
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 Measure Information:
Title
correlation between caries activity and efficacy of three groups
Description
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
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sneha D Suwarnkar, MDS
Organizational Affiliation
Saraswati Dhanwantari Dental College and Hospital, Parbhani
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr Sneha D Suwarnkar
City
Parbhani
State/Province
Maharashtra
ZIP/Postal Code
431401
Country
India
12. IPD Sharing Statement
Learn more about this trial
Management of Occlusal Dentinal Caries in Deciduous Molars
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