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Selective Caries vs Stepwise Caries Removal Technique in Deep Carious Lesions

Primary Purpose

Caries

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Selective caries removal
Stepwise caries removal
Sponsored by
Postgraduate Institute of Dental Sciences Rohtak
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Caries

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Post Graduate Institute of Dental ScienceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Selective caries removal to soft dentin (one step)

Stepwise caries removal (two step)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Clinical success
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.

Secondary Outcome Measures

Radiographic Success
Absence of periapical alterations (radiolucency at furcal or periapical region).

Full Information

First Posted
April 24, 2020
Last Updated
May 3, 2020
Sponsor
Postgraduate Institute of Dental Sciences Rohtak
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1. Study Identification

Unique Protocol Identification Number
NCT04375215
Brief Title
Selective Caries vs Stepwise Caries Removal Technique in Deep Carious Lesions
Official Title
Success of Selective Caries vs Stepwise Caries Removal Technique in Deep Carious Lesions- A Randomized Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
April 30, 2021 (Anticipated)
Study Completion Date
June 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Postgraduate Institute of Dental Sciences Rohtak

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomized clinical study
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
146 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Selective caries removal to soft dentin (one step)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Stepwise caries removal (two step)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Selective caries removal
Intervention Description
After caries removal restoration of tooth will be performed
Intervention Type
Procedure
Intervention Name(s)
Stepwise caries removal
Intervention Description
After caries removal restoration of tooth will be performed
Primary Outcome Measure Information:
Title
Clinical success
Description
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.
Time Frame
Baseline to 12 months
Secondary Outcome Measure Information:
Title
Radiographic Success
Description
Absence of periapical alterations (radiolucency at furcal or periapical region).
Time Frame
Baseline to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Post Graduate Institute of Dental Science
City
Rohtak
State/Province
Haryana
ZIP/Postal Code
124001
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sanjay TEWARI
Phone
01262283876
Email
principalpgids@yahoo.in

12. IPD Sharing Statement

Plan to Share IPD
No

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Selective Caries vs Stepwise Caries Removal Technique in Deep Carious Lesions

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