CariesNCT04375215
Selective Caries vs Stepwise Caries Removal Technique in Deep Carious Lesions
A study testing Selective caries removal and Stepwise caries removal in people with Caries, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Caries
- What is being tested?
- Selective caries removal and Stepwise caries removal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jan 2020to 15 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Any general disease affecting the caries e.g. patient under head and neck radiotherapy
- Patients with immuno-compromised status
- Tooth with fracture line, cracks.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Post Graduate Institute of Dental Science
Rohtak, Haryana, 124001
Sanjay TEWARI, 01262283876, principalpgids@yahoo.in
About this study
Official title: 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.
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.
- Conditions
- Caries
- Being tested
- Selective caries removal, Stepwise caries removal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective caries removalProcedure or surgery
After caries removal restoration of tooth will be performed
Stepwise caries removalProcedure or surgery
After caries removal restoration of tooth will be performed
| Study group | Role | What they receive |
|---|---|---|
| Selective caries removal to soft dentin (one step) | Active comparator | 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. Receives: Procedure: Selective caries removal |
| Stepwise caries removal (two step) | Active comparator | 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. Receives: Procedure: Stepwise caries removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 12 months
Secondary outcomes (1)
Radiographic Success
Absence of periapical alterations (radiolucency at furcal or periapical region).
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start1 Jan 2020
- Primary completion30 Apr 2021 (estimated)
- Study completion15 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized clinical study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04375215
- Sponsor's protocol ID
- VISHALPGIDS
- Status last verified
- May 2020
- First submitted
- 24 Apr 2020
- Last updated
- 5 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Success of Selective Caries vs Stepwise Caries Removal Technique in Deep Carious Lesions- A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT04375215
- Acronym / sponsor ID
- VISHALPGIDS
- Conditions
- Caries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 15 Jun 2021 (estimated)
- First posted
- 5 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective randomized clinical study
| Arm | Type | Receives |
|---|---|---|
| Selective caries removal to soft dentin (one step) | Active comparator | Procedure: Selective caries removalIn 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. |
| Stepwise caries removal (two step) | Active comparator | Procedure: Stepwise caries removalThe 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Any general disease affecting the caries e.g. patient under head and neck radiotherapy
- Patients with immuno-compromised status
- Tooth with fracture line, cracks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Selective caries removalAfter caries removal restoration of tooth will be performed | Procedure or surgery | Selective caries removal to soft dentin (one step) |
| Stepwise caries removalAfter caries removal restoration of tooth will be performed | Procedure or surgery | Stepwise caries removal (two step) |
Primary outcome
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.
1 secondary outcome
Radiographic Success
Time frame: Baseline to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selective caries removal and Stepwise caries removal in people with Caries, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical success (time frame: Baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2020.