MOD: Management of Occlusal Dentinal Caries in Deciduous Molars

• Sponsor: Sneha D. Suwarnkar (Other)
• Overall Status: Completed
• CT.gov ID: NCT03552835
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 3
• Actual Duration (Months): 13.3
• Patients Per Site Per Month: 4.5

Study Details

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.

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	N/A

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 Design

• Study Type: Interventional
• 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 comparedocclusal 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: Oct 30, 2017
• Actual Primary Completion Date: Nov 30, 2018
• Actual Study Completion Date: Dec 10, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 7 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dr Sneha D Suwarnkar	Parbhani	Maharashtra	India	431401

Sponsors and Collaborators

• Sneha D. Suwarnkar

Investigators

• Principal Investigator: Sneha D Suwarnkar, MDS, Saraswati Dhanwantari Dental College and Hospital, Parbhani

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sneha D. Suwarnkar, Principal investigator, Saraswati-Dhanwantari Dental College & Hospital
• ClinicalTrials.gov Identifier: NCT03552835
• Other Study ID Numbers: SarswatiDhanwantari
• First Posted: Jun 12, 2018
• Last Update Posted: Jan 10, 2019
• Last Verified: Jan 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sneha D. Suwarnkar, Principal investigator, Saraswati-Dhanwantari Dental College & Hospital: no caries removal; partial caries removal upto soft dentin; partial caries removal upto firm dentin
• Additional relevant MeSH terms: Dental Caries

Study Results

No Results Posted as of Jan 10, 2019