Selective Caries vs Stepwise Caries Removal Technique in Deep Carious Lesions

May 3, 2020 updated by: Postgraduate Institute of Dental Sciences Rohtak

Success of Selective Caries vs Stepwise Caries Removal Technique in Deep Carious Lesions- A Randomized Clinical Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

146

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Haryana
      • Rohtak, Haryana, India, 124001
        • Recruiting
        • Post Graduate Institute of Dental Science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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.
Procedure: Selective caries removal
After caries removal restoration of tooth will be performed
ACTIVE_COMPARATOR: 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.
Procedure: Stepwise caries removal
After caries removal restoration of tooth will be performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical success
Time Frame: Baseline to 12 months

Clinical success will be judged by following criteria

  • Positive response on vitality test.
  • Absence of pain on percussion and any other signs and/or symptoms of irreversible pulpitis and pulp necrosis

Criteria for failure will be

  • Negative response on pulp vitality test.
  • Tenderness to percussion and teeth exhibiting any clinical signs and/or symptoms of irreversible pulpitis and pulp necrosis.
Baseline to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic Success
Time Frame: Baseline to 12 months
Absence of periapical alterations (radiolucency at furcal or periapical region).
Baseline to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Postgraduate Institute of Dental Sciences Rohtak

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2020

Primary Completion (ANTICIPATED)

April 30, 2021

Study Completion (ANTICIPATED)

June 15, 2021

Study Registration Dates

First Submitted

April 24, 2020

First Submitted That Met QC Criteria

May 3, 2020

First Posted (ACTUAL)

May 5, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 5, 2020

Last Update Submitted That Met QC Criteria

May 3, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VISHALPGIDS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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