Selective Caries vs Stepwise Caries Removal Technique in Deep Carious Lesions

NCT ID: NCT04375215

Last Updated: 2020-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2021-06-15

Brief Summary

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The aim of this clinical study is to compare and evaluate the Success of Selective Caries vs Stepwise Caries Removal Techniques in treatment of dental caries.

Detailed Description

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The patient will be selected as per the pre-defined eligibility criteria. Written informed consent will be taken from each consenting participant. Initial caries excavation will be done under rubber dam isolation. The patient will then be randomly allocated to two groups: selective removal to soft dentin or stepwise caries removal. Composite restoration with glass ionomer liner will be then placed in both groups. Additional complete caries excavation will be done in the stepwise caries removal group after six months.

Conditions

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Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective randomized clinical study
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Selective caries removal to soft dentin (one step)

In selective caries removal to soft dentine, after caries excavation application of liner will be done on pulpal floor. Teeth will then be filled with composite resin material.

Group Type ACTIVE_COMPARATOR

Selective caries removal

Intervention Type PROCEDURE

After caries removal restoration of tooth will be performed

Stepwise caries removal (two step)

The stepwise caries removal is a two step procedure. The first step is similar to selective caries removal to soft dentin group. In the second step, after 6 months lesion will be re-entered to remove remaining carious tissue till firm dentin is encountered. Once all the caries is removed from floor of cavity a liner followed by final restoration with composite will be performed.

Group Type ACTIVE_COMPARATOR

Stepwise caries removal

Intervention Type PROCEDURE

After caries removal restoration of tooth will be performed

Interventions

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Selective caries removal

After caries removal restoration of tooth will be performed

Intervention Type PROCEDURE

Stepwise caries removal

After caries removal restoration of tooth will be performed

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Outpatient in age range of 18yr-60yr
* Permanent mandibular posterior teeth with deep caries
* Caries extending to \>3/4 of dentin with a layer of sound dentin between pulp and carious tissue as seen on radiograph
* Positive response to cold test and electric pulp test

Exclusion Criteria

* Any general disease affecting the caries e.g. patient under head and neck radiotherapy
* Patients with immuno-compromised status
* Tooth with fracture line, cracks.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Postgraduate Institute of Dental Sciences Rohtak

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Post Graduate Institute of Dental Science

Rohtak, Haryana, India

Site Status RECRUITING

Countries

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India

Facility Contacts

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Sanjay TEWARI

Role: primary

01262283876

Other Identifiers

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VISHALPGIDS

Identifier Type: -

Identifier Source: org_study_id

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