Calcium Hydroxide, Mineral Trioxide Aggregate and Biodentine (Trademark) as Direct Pulp Capping of Permanent Teeth

Universidad de los Andes, Chile

Status and phase: Completed; Phase 3; Phase 2

Conditions: Caries; Dental Pulp Exposure

Treatments: Drug: Mineral trioxide aggregate; Drug: Calcium hydroxide; Drug: Biodentine

Study type: Interventional

Funder types: Other

Identifiers

NCT02492841

SA13I20175 (Other Grant/Funding Number)

RPD-7-16

Details and patient eligibility

About

Background: Dental caries is considered an oral health problem worldwide. In Chile the last national epidemiological study (2007) showed a national prevalence of dental caries in children 6 years (70.3%) and 12 (62.5%). Direct pulp capping is a preventive dental therapy, keeps the vitality of the tooth using some inductive materials mineralized tissue formation.

Objective: The main objective of this study is to evaluate the effectiveness of two innovative direct pulp capping materials; Biodentine compared MTA and calcium hydroxide in the maintenance of pulp vitality in teeth permanent molars.

Full description

Methodology: It is a randomized controlled study. groups signed the informed consent for clinical trial patients, a clinical evaluation of 90 permanent molars teeth through endodontic diagnostic tests and radiograph. will be conducted to determine diagnosis. Will be assigned randomly to the type of material to use and direct pulp teeth affected by caries coating is carried out; Patients will not have knowledge of the material to be used in the coating. The patient will be clinically evaluated at 1 week, 3 months and 8 months, and radiographically; at the beginning and end of the study. In each clinical control endodontic diagnostic tests of heat, cold, electric and percussion will be performed. In radiographic controls take a radiograph control with positioner or surveyor at baseline and 8 months, to evaluate the periapical status. Clinical success will consider that tooth in continuous controls and after 8 months presented vitality and radiographic signs of apical image without injury. Failure unresponsive to consider whether susceptibility testing of cold and electricity in more than one control and presents radiographic image with apical lesion.

Enrollment: 169 patients

Sex: All

Ages: 7 to 16 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Systemically healthy patients
• Patients with at least one full or partial tooth root development
• Clinical examination of the tooth must be selected diagnostic tests that are consistent with reversible pulpitis
• Radiographic examination should show images of normal tissues without signs of internal resorption, the remaining healthy coronary should be sufficient for an indication of direct restoration
• Teeth that have pulp exposure not exceeding 1 mm in size.

Exclusion criteria

• Every child with systemic and / or neurological conditions that make it impossible to focus on conventional dental clinic
• Teeth uncontrolled excessive bleeding during communication pulp those aiming or have plans to move during that time period of 8 months .

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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169 participants in 3 patient groups

Mineral trioxide aggregate (MTA)

Experimental group

Description:

Mineral trioxide aggregate Root canal repair material

Treatment:

Drug: Mineral trioxide aggregate

Calcium hydroxide

Active Comparator group

Description:

-material for pulp capping

Treatment:

Drug: Calcium hydroxide

Biodentine

Experimental group

Description:

Is a calcium-silicate based materia root perforations, apexification, resorptive lesions, and retrograde filling material in endodontic surgery, pulp capping

Treatment:

Drug: Biodentine