Management of Occlusal Dentinal Caries in Deciduous Molars

Not Applicable

Completed

• Conditions: Caries, Dental
• Interventions: Procedure: partial caries removal upto soft dentin; Procedure: no caries removal; Procedure: partial caries removal upto firm dentin

• Registration Number: NCT03552835
• Lead Sponsor: Sneha D. Suwarnkar

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.

Study Timeline

• Study Start: 2017-10-30
• Study First Submitted: 2018-05-30
• Study First Submitted QC: 2018-05-30
• Study First Posted: 2018-06-12
• Primary Completion: 2018-11-30
• Study Completion: 2018-12-10
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-08
• Last Update Posted: 2019-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
partial caries removal upto soft dentin	partial caries removal upto soft dentin	mandibular occlusal caries were treated by partial caries removal upto soft dentin
no caries removal	no caries removal	mandibular occlusal caries were treated with placement of stainless steel crown with no caries removal
partial caries removal upto firm dentin	partial caries removal upto firm dentin	mandibular occlusal caries were treated by partial caries removal upto firm dentin

Primary Outcome Measures

Name	Time	Method
correlation between caries activity and efficacy of three groups	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

Trial Locations

Locations (1)

Dr Sneha D Suwarnkar; 🇮🇳 Parbhani, Maharashtra, India