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Status unknownNCT04375215Updated May 5, 2020

Selective Caries vs Stepwise Caries Removal Technique in Deep Carious Lesions

An interventional study of Selective caries removal and Stepwise caries removal in Caries, sponsored by Postgraduate Institute of Dental Sciences Rohtak. Status unknown at 1 site in India. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-05-05.

Sponsored by Postgraduate Institute of Dental Sciences Rohtak · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2020), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Jan 2020, registered Apr 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
146
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Caries

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03

In context

Dental Caries

1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.

This study's planned enrollment of 146 is above the median of 60 across 916 interventional studies indexed under Dental Caries.

Browse Dental Caries studies →

Lead sponsor

Postgraduate Institute of Dental Sciences Rohtak is the lead sponsor of 209 studies on the registry; 71 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
146 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • ProcedureSelective caries removal

    After caries removal restoration of tooth will be performed

  • ProcedureStepwise caries removal

    After caries removal restoration of tooth will be performed

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline to 12 months

Secondary outcomes

  1. Radiographic Success

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

    Time frame: Baseline to 12 months

07

Study locations

1 of 1 sites recruiting
  • Post Graduate Institute of Dental Science
    Rohtak, Haryana 124001, India
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04375215
Lead sponsor
Postgraduate Institute of Dental Sciences Rohtak
Responsible party
Sponsor
First posted
May 5, 2020
Start date
Jan 1, 2020
Primary completion
Apr 30, 2021 (estimated)
Completion
Jun 15, 2021 (estimated)
Last update
May 5, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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