Management of Occlusal Dentinal Caries in Deciduous Molars

Caries, Dental Clinical Trial

— MOD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03552835
• Other study ID #: SarswatiDhanwantari
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Caries, Dental
• Dental Caries

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