Comparison of Conventional Versus Conservative Caries Removal in Primary Teeth

NCT03650647 | Unknown DMC

• 1 other identifier: ARibeiro
• Study Type: interventional
• Target: 49
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Dental Caries Extending Into Dentin

Keywords

Dental caries; Dentin; Pulp exposure prevention; Deep caries lesion; Conservative Treatment

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Through study completion, up to three years.

Study Arms (3)

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

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

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

Procedure: Carious dentin removal

Interventions

Carious dentin removal PROCEDURE

Carious tissue removal and managing deep cavitated carious lesions in primary teeth.

Also known as: Indirect Pulp Capping, Stepwise excavation, Selective caries removal

Indirect Pulp Capping; Selective caries removal; Stepwise excavation

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal Fluminense: lead

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Apoena A Ribeiro, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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).

Study Record Dates

• First Submitted: August 21, 2018
• First Posted: August 29, 2018
• Study Start: January 15, 2017
• Primary Completion: January 15, 2018
• Study Completion: January 5, 2020
• Last Updated: August 29, 2018

Record last verified: 2018-08