NCT03552835

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 30, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 12, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2018

Completed
Last Updated

January 10, 2019

Status Verified

January 1, 2019

Enrollment Period

1.1 years

First QC Date

May 30, 2018

Last Update Submit

January 8, 2019

Conditions

Caries, Dental

Keywords

no caries removalpartial caries removal upto soft dentinpartial caries removal upto firm dentin

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

no caries removal

EXPERIMENTAL

mandibular occlusal caries were treated with placement of stainless steel crown with no caries removal

Procedure: no caries removal

partial caries removal upto soft dentin

EXPERIMENTAL

mandibular occlusal caries were treated by partial caries removal upto soft dentin

Procedure: partial caries removal upto soft dentin

partial caries removal upto firm dentin

EXPERIMENTAL

mandibular occlusal caries were treated by partial caries removal upto firm dentin

Procedure: partial caries removal upto firm dentin

Interventions

no caries removalPROCEDURE

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

no caries removal
partial caries removal upto soft dentinPROCEDURE

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 soft dentin
partial caries removal upto firm dentinPROCEDURE

occlusal caries were treated by partial caries removal upto firm dentin followed by Glass Ionomer Cement placement as a base and composite restoration

partial caries removal upto firm dentin

Eligibility Criteria

Age4 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr Sneha D Suwarnkar

Parbhani, Maharashtra, 431401, India

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Sneha D Suwarnkar, MDS

    Saraswati Dhanwantari Dental College and Hospital, Parbhani

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 30, 2018

First Posted

June 12, 2018

Study Start

October 30, 2017

Primary Completion

November 30, 2018

Study Completion

December 10, 2018

Last Updated

January 10, 2019

Record last verified: 2019-01

Locations

IN(1)