Comparison of Conventional Versus Conservative Caries Removal in Primary Teeth (Caries_removal)

August 24, 2018 updated by: Apoena de Aguiar Ribeiro, Universidade Federal Fluminense

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The aims of this Randomized Clinical Trial are:

  1. 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);
  2. 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;
  3. to clinically evaluate dentin reactions to the SE;
  4. 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;
  5. to determine, in vitro, the microbial metabolome of different strains isolated from dentin samples under conditions of high and low cariogenic challenge;
  6. 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 Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

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

4 years to 6 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. The child need to be healthy;
  2. This should be in the age range of 4 to 6 years of age;
  3. 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.

Exclusion Criteria:

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

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: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Indirect Pulp Capping

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
Procedure: Carious dentin removal
Carious tissue removal and managing deep cavitated carious lesions in primary teeth.
Other Names:
  • Indirect Pulp Capping
  • Stepwise excavation
  • Selective caries removal
Experimental: Stepwise excavation

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
Procedure: Carious dentin removal
Carious tissue removal and managing deep cavitated carious lesions in primary teeth.
Other Names:
  • Indirect Pulp Capping
  • Stepwise excavation
  • Selective caries removal
Experimental: Selective caries removal

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
Procedure: Carious dentin removal
Carious tissue removal and managing deep cavitated carious lesions in primary teeth.
Other Names:
  • Indirect Pulp Capping
  • Stepwise excavation
  • Selective caries removal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, up to three years.
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.
Through study completion, up to three years.

Collaborators and Investigators

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

Sponsor

Universidade Federal Fluminense

Investigators

  • Principal Investigator: Apoena A Ribeiro, PhD, University of North Carolina, Chapel Hill

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 15, 2017

Primary Completion (Actual)

January 15, 2018

Study Completion (Anticipated)

January 5, 2020

Study Registration Dates

First Submitted

August 21, 2018

First Submitted That Met QC Criteria

August 24, 2018

First Posted (Actual)

August 29, 2018

Study Record Updates

Last Update Posted (Actual)

August 29, 2018

Last Update Submitted That Met QC Criteria

August 24, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARibeiro

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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