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NCT Number: NCT02492841

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

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.

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Key information

Conditions

Caries Dental Pulp Diseases Dental Pulp Exposure Stomatognathic Diseases Tooth Diseases

Age range

7 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Centro de Salud de San Bernardo Universidad de Los Andes

Santiago, Chile

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

Mineral Trioxide Aggregate

Drug

Mineral trioxide aggregate

Other names: MTA Pro Root

Calcium hydroxide

Drug

Classic calcium hydroxide root canal repair material. Inorganic compound (CA(OH)2. It is the gold standard direct pulp cupping material.

Other names: Calcium hydroxide Hertz

Biodentine

Drug

Biodentine (trademark). Septodont. Biodentine root canal repair material. A predose capsule plus five drops of calcium chloride solution.

Other names: Active biosilicate. Septodont.

Primary outcomes

  1. Parameters Evaluated After Treatment

    Time frame: 3 months, 6 moths and 12 months

    vitality test with electric device cold and hot test radiographic evaluation

Secondary outcomes

  1. Number of Participants With Adverse Effects

    Time frame: 1 week, 3 and 6 months

    Name any adverse effects caused by treatment.

Sponsors and collaborators

Lead sponsor

Universidad de los Andes, Chile

Other

Registry information

Official study title

Controlled Clinical Trial of the Effect of Calcium Hydroxide, Mineral Trioxide Aggregate (MTA) and Biodentine (Trademark) as Direct Pulp Capping Materials of Permanent Teeth Affected by Caries, in Children From 7 to 16 Years

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 9, 2015
Registry last updated
May 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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