Dental Caries Extending Into DentinCaries_removalNCT03650647

Comparison of Conventional Versus Conservative Caries Removal in Primary Teeth

A study testing Carious dentin removal in people with Dental Caries Extending Into Dentin, run by Universidade Federal Fluminense.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 4 to 6 yearsHealthy volunteers can take part
Conditions the study is for: Dental Caries Extending Into Dentin
What is being tested?: Carious dentin removal
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 49 participants
Where: No sites listed yet
Study dates: 15 Jan 2017to 5 Jan 2020
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 4 to 6 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

The child need to be healthy;
This should be in the age range of 4 to 6 years of age;
The primary molars to be submitted to treatment should have the following characteristics: deep caries lesion (greater than or equal to 2/3 of dentine thickness) without clinical or radiographic aspects of pulp lesion, restoration margins above gingival line, absence of spontaneous pain or mobility, absence of periodontal changes, roots compatible with pulpal maturation stage.

Who cannot join

Children under use of controlled drugs or antibiotics.
Children who presented with some neurological or motor disorder that could influence the treatment procedure.
Molars with more than three lost walls or margins in subgingival area.
Patients with allergies to the medications used.
Patients in the pulpal regression stage in which the tooth is likely to be lost within 12 months.

About this study

Official title: Randomized Clinical Trial Comparison of Conventional Versus Conservative Caries Removal in Primary Teeth: a Two-year Evaluation

The sample will be, at least, 90 primary molars, randomly distributed into three groups: Group 1: IPC; Group 2: SE; Group 3: SCR. Teeth must present deep caries lesions (at least 2/3 of dentin depth), pulp vitality (no clinical or radiographical signs of pulp disease, such as abcesses, fistulae, root resorption, abnormal tooth mobility). This study received approval by the Ethics Committee of Fluminense Federal University (UFF; Brazil) - # CAAE: 58812816.8.0000.5626. The study started in January, 2017; and will finish in December, 2020. Patients will be selected from the public schools in Nova Friburgo. The dental exams and treatment procedures will be done at the clinics from the

School of Dentistry, Health Institute of Nova Friburgo (ISNF). Laboratory proceedings will be done at:

Clinical and Microbiological Research Laboratory (LAB PECMA - ISNF) - Sample storage, bacterial cultivation and identification.
University of North Carolina at Chapel Hill
Rio de Janeiro Federal University

Read the detailed description

The aims of this Randomized Clinical Trial are:

to evaluate the risk of pulpal exposure and tooth vitality maintenance of primary molars with deep caries lesions, treated with conservative techniques, such as Stepwise Excavation (SE) or Selective Caries Removal (SCR), and to compare with those teeth treated with Indirect Pulp Capping (IPC);
to verify changes in the cultivable microbiota isolated in the deep carious dentin lesions of deciduous molars, before and after performing the procedures of SE;
to clinically evaluate dentin reactions to the SE;
to provide longitudinal monitoring of changes in the non-cultivable microbiota (microbiome), found in dentin carious lesions of deciduous and permanent molars, compared to the treatments performed;
to determine, in vitro, the microbial metabolome of different strains isolated from dentin samples under conditions of high and low cariogenic challenge;
to correlate, in vitro, the microbial metabolites with the clinical classification of the cavitated lesions from which these samples originated.

The sample will be, at least, 90 primary molars, randomly distributed into three groups: Group 1: IPC; Group 2: SE; Group 3: SCR. Teeth must present deep caries lesions (at least 2/3 of dentin depth), pulp vitality (no clinical or radiographical signs of pulp disease, such as abcesses, fistulae, root resorption, abnormal tooth mobility). This study received approval by the Ethics Committee of UFF (Brazil) - # CAAE: 58812816.8.0000.5626. The study started in January, 2017; and will finish in December, 2020. Patients will be selected from the public schools in Nova Friburgo. The dental exams and treatment procedures will be done at the clinics from the

School of Dentistry, Health Institute of Nova Friburgo (ISNF). Laboratory proceedings will be done at:

LAB PECMA - ISNF - Sample storage, bacterial cultivation and identification University of North Carolina at Chapel Hill Rio de Janeiro Federal University

Conditions: Dental Caries Extending Into Dentin
Being tested: Carious dentin removal
Keywords: Dental caries, Dentin, Pulp exposure prevention, Deep caries lesion, Conservative Treatment
Medical subject headings: Dental Caries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Carious dentin removalProcedure or surgery
Also called Indirect Pulp Capping, Stepwise excavation, Selective caries removal
Carious tissue removal and managing deep cavitated carious lesions in primary teeth.

Study groups in NCT03650647
Study group	Role	What they receive
Indirect Pulp Capping	Active comparator	Nonselective removal to hard dentine (formerly complete excavation or complete caries removal) : removal of soft dentin, only hard dentine is left on the cavity, so that demineralized dentine "free" of bacteria is completely removed. Intervention: Total soft and leathery caries removal. Carious dentin removal Receives: Procedure: Carious dentin removal
Stepwise excavation	Experimental	Stepwise removal is carious tissue removal in 2 stages, i.e., visits. Soft carious tissue is left over the pulp in the first step, while peripheral dentine is prepared to hard dentine to allow a complete and durable seal of the lesion. A provisional restoration is placed, which should be sufficiently durable to last up to 6 months to allow changes in the dentine and pulp to take place. After this period, a second excavation is done and, if there is hard dentin formed, the tooth is restored. Intervention: Part of the soft caries is removed. Final restoration is placed on the second visit. Carious dentin removal Receives: Procedure: Carious dentin removal
Selective caries removal	Experimental	Selective caries removal: only part the soft dentine is removed, so soft carious tissue is left over the pulp, while peripheral enamel and dentine are prepared to hard dentine, to allow a tight seal and placement of a durable restoration. Intervention: Part of the soft caries is removed. Final restoration is place over the soft dentin. Carious dentin removal Receives: Procedure: Carious dentin removal

What is being measured

The primary outcome is the main question the study is designed to answer.

Pulp vitality maintenance diagnosed by clinical exam
Among the three treatment protocols, which one will have better prognosis in maintaining pulp vitality. The clinical parameters of pulpal failures are: pain, presence of abscess, fistulae and/or abnormal tooth mobility.
Measured: Through study completion, up to three years.
Pulp vitality maintenance diagnosed by radiograph exam
The prognosis of maintaining pulp vitality will be acessed by radiological signs of loss of vitality, as presence of abnormal root resorption and/or bone resorption.
Measured: Through study completion, up to three years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jan 20175 Jan 2020

First posted29 Aug 2018
Study start15 Jan 2017
Primary completion15 Jan 2018
Study completion5 Jan 2020 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Dental Caries Extending Into DentinStudies 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: Factorial
Model description: Tooth receive one of the two test treatments: Stepwise Excavation (conservative treatment 1), Selective caries removal (conservative treatment 2) and are evaluated in parallel against a control group (indirect pulp capping treatment).
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 49 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03650647
Sponsor's protocol ID: ARibeiro
Acronym: Caries_removal
Status last verified: Aug 2018
First submitted: 21 Aug 2018
Last updated: 29 Aug 2018
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruiting
Clinical Evaluation of Different Bulk-Fill Restorative Materials in Primary Molars
Decayed Primary Molars, Decayed Tooth
Not yet recruitingPhase 3
Effectiveness of Single and Dual Silver Fluoride Application
Dentine Caries
Not yet recruitingPhase 2
A Clinical Study of KH001 for Pulp Preservation and Safety in Deep Dentin Caries
Dental Caries
Recruiting
PMCF Study on The Performance and Safety of ON DENT® PMMA Discs/Blocks and Resin Products for Temporary Restorations
Tooth Loss, Dentin Caries
Recruiting
Polymer Induced Liquid Precursor (PILP) in Adults in With Dentin Caries
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All Dental Caries Extending Into Dentin trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Clinical Trial Comparison of Conventional Versus Conservative Caries Removal in Primary Teeth: a Two-year Evaluation
ClinicalTrials.gov ID: NCT03650647
Acronym / sponsor ID: Caries_removal / ARibeiro
Conditions: Dental Caries Extending Into Dentin
Keywords: Dental caries, Dentin, Pulp exposure prevention, Deep caries lesion, Conservative Treatment
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 49 participants (actual)
Lead sponsor: Universidade Federal FluminenseUniversity, hospital or other
Study start: 15 Jan 2017 (actual)
Primary completion: 15 Jan 2018 (actual)
Study completion: 5 Jan 2020 (estimated)
First posted: 29 Aug 2018 (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.

School of Dentistry, Health Institute of Nova Friburgo (ISNF). Laboratory proceedings will be done at:

Clinical and Microbiological Research Laboratory (LAB PECMA - ISNF) - Sample storage, bacterial cultivation and identification.
University of North Carolina at Chapel Hill
Rio de Janeiro Federal University

Detailed description

The aims of this Randomized Clinical Trial are:

to evaluate the risk of pulpal exposure and tooth vitality maintenance of primary molars with deep caries lesions, treated with conservative techniques, such as Stepwise Excavation (SE) or Selective Caries Removal (SCR), and to compare with those teeth treated with Indirect Pulp Capping (IPC);
to verify changes in the cultivable microbiota isolated in the deep carious dentin lesions of deciduous molars, before and after performing the procedures of SE;
to clinically evaluate dentin reactions to the SE;
to provide longitudinal monitoring of changes in the non-cultivable microbiota (microbiome), found in dentin carious lesions of deciduous and permanent molars, compared to the treatments performed;
to determine, in vitro, the microbial metabolome of different strains isolated from dentin samples under conditions of high and low cariogenic challenge;
to correlate, in vitro, the microbial metabolites with the clinical classification of the cavitated lesions from which these samples originated.

The sample will be, at least, 90 primary molars, randomly distributed into three groups: Group 1: IPC; Group 2: SE; Group 3: SCR. Teeth must present deep caries lesions (at least 2/3 of dentin depth), pulp vitality (no clinical or radiographical signs of pulp disease, such as abcesses, fistulae, root resorption, abnormal tooth mobility). This study received approval by the Ethics Committee of UFF (Brazil) - # CAAE: 58812816.8.0000.5626. The study started in January, 2017; and will finish in December, 2020. Patients will be selected from the public schools in Nova Friburgo. The dental exams and treatment procedures will be done at the clinics from the

School of Dentistry, Health Institute of Nova Friburgo (ISNF). Laboratory proceedings will be done at:

LAB PECMA - ISNF - Sample storage, bacterial cultivation and identification University of North Carolina at Chapel Hill Rio de Janeiro Federal University

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3
Model description: Tooth receive one of the two test treatments: Stepwise Excavation (conservative treatment 1), Selective caries removal (conservative treatment 2) and are evaluated in parallel against a control group (indirect pulp capping treatment).

Arm	Type	Receives
Indirect Pulp Capping	Active comparator	Procedure: Carious dentin removalNonselective removal to hard dentine (formerly complete excavation or complete caries removal) : removal of soft dentin, only hard dentine is left on the cavity, so that demineralized dentine "free" of bacteria is completely removed. Intervention: Total soft and leathery caries removal. Carious dentin removal
Stepwise excavation	Experimental	Procedure: Carious dentin removalStepwise removal is carious tissue removal in 2 stages, i.e., visits. Soft carious tissue is left over the pulp in the first step, while peripheral dentine is prepared to hard dentine to allow a complete and durable seal of the lesion. A provisional restoration is placed, which should be sufficiently durable to last up to 6 months to allow changes in the dentine and pulp to take place. After this period, a second excavation is done and, if there is hard dentin formed, the tooth is restored. Intervention: Part of the soft caries is removed. Final restoration is placed on the second visit. Carious dentin removal
Selective caries removal	Experimental	Procedure: Carious dentin removalSelective caries removal: only part the soft dentine is removed, so soft carious tissue is left over the pulp, while peripheral enamel and dentine are prepared to hard dentine, to allow a tight seal and placement of a durable restoration. Intervention: Part of the soft caries is removed. Final restoration is place over the soft dentin. Carious dentin removal

Who may qualify

Ages: 4 to 6 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

The child need to be healthy;
This should be in the age range of 4 to 6 years of age;
The primary molars to be submitted to treatment should have the following characteristics: deep caries lesion (greater than or equal to 2/3 of dentine thickness) without clinical or radiographic aspects of pulp lesion, restoration margins above gingival line, absence of spontaneous pain or mobility, absence of periodontal changes, roots compatible with pulpal maturation stage.

Key exclusion criteria (5 listed)

Children under use of controlled drugs or antibiotics.
Children who presented with some neurological or motor disorder that could influence the treatment procedure.
Molars with more than three lost walls or margins in subgingival area.
Patients with allergies to the medications used.
Patients in the pulpal regression stage in which the tooth is likely to be lost within 12 months.

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
Carious dentin removalAlso: Indirect Pulp Capping, Stepwise excavation, Selective caries removalCarious tissue removal and managing deep cavitated carious lesions in primary teeth.	Procedure or surgery	Indirect Pulp Capping, Selective caries removal, Stepwise excavation

Primary outcome

Pulp vitality maintenance diagnosed by clinical exam
Time frame: Through study completion, up to three years.
Among the three treatment protocols, which one will have better prognosis in maintaining pulp vitality. The clinical parameters of pulpal failures are: pain, presence of abscess, fistulae and/or abnormal tooth mobility.
Pulp vitality maintenance diagnosed by radiograph exam
Time frame: Through study completion, up to three years.
The prognosis of maintaining pulp vitality will be acessed by radiological signs of loss of vitality, as presence of abnormal root resorption and/or bone resorption.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.

Related trials for Dental Caries Extending Into Dentin

Not yet recruiting
Clinical Evaluation of Different Bulk-Fill Restorative Materials in Primary Molars
Decayed Primary Molars, Decayed Tooth
Not yet recruitingPhase 3
Effectiveness of Single and Dual Silver Fluoride Application
Dentine Caries
Not yet recruitingPhase 2
A Clinical Study of KH001 for Pulp Preservation and Safety in Deep Dentin Caries
Dental Caries
Recruiting
PMCF Study on The Performance and Safety of ON DENT® PMMA Discs/Blocks and Resin Products for Temporary Restorations
Tooth Loss, Dentin Caries
Recruiting
Polymer Induced Liquid Precursor (PILP) in Adults in With Dentin Caries
Dental Caries

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.

Apoena A Ribeiro, PhD principal investigator

University of North Carolina, Chapel Hill

Questions about this trial

What is this clinical trial studying?

A study testing Carious dentin removal in people with Dental Caries Extending Into Dentin, run by Universidade Federal Fluminense.

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 3 inclusion and 5 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 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pulp vitality maintenance diagnosed by clinical exam (time frame: Through study completion, up to three years.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03650647.

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 29 Aug 2018.