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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03552835
Other study ID # SarswatiDhanwantari
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 30, 2017
Est. completion date December 10, 2018

Study information

Verified date January 2019
Source Saraswati-Dhanwantari Dental College & Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 10, 2018
Est. primary completion date November 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 4 Years to 7 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
India Dr Sneha D Suwarnkar Parbhani Maharashtra

Sponsors (1)

Lead Sponsor Collaborator
Sneha D. Suwarnkar

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 12 months
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