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Randomized clinical trial of three materials after partial caries removal in primary teeth

Randomized clinical trial of three pulp capping materials after partial caries removal in primary teeth

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5sb8sb
Enrollment
Unknown
Registered
2016-03-01
Start date
2015-09-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental caries

Interventions

Experimental Group 1: Mineral trioxide aggregate (MTA Angelus Londrina PR - BR). Experimental Group 1: Portland Cement (Votorantim Cimentos São Paulo - BR). Control Group: Calcium hydroxide cement (Hy
Procedure/surgery

Sponsors

Faculdade de Odontologia de Bauru
Lead Sponsor
Thais Marchini de Oliveira
Collaborator

Eligibility

Age
5 Years to 9 Years

Inclusion criteria

Inclusion criteria: The sample inclusion criteria comprise children between 5-9 years old of both genders, that do not present systemic diseases; no allergic reaction history to the latex rubber dam and / or local anesthetic; with at least one or two primary molars (upper / lower) committed by deep decay that reaches two thirds of the dentin; occlusal and / or occlusal-proximal caries; with lack of sensitivity and / or spontaneous pain; absence of pulp exposure; absence of excessive mobility; absence of fistula or abscess; Radiographic absence of internal and external resorption; Radiographic absence of root resorption greater than 1/3 of the root; Radiographic absence of radiolucent image in the periapical region and furca that might indicate the presence of irreversible pulpitis or pulp necrosis; gum apparently healthy place; and tooth restorative possibility (BRESSANI et al, 2013;. Petrou et al, 2013;. SCHWENDICKE et al, 2015.).

Exclusion criteria

Exclusion criteria: Exclusion criteria comprise presence of systemic diseases; history of allergic reaction to the latex rubber dam and / or local anesthetic (BRESSANI et al, 2013;. SCHWENDICKE et al, 2015.).

Design outcomes

Primary

MeasureTime frame
The clinical performance of the teeth to partial removal of deep caries must be improve. The evaluation will be ninety-three and / or second upper and lower molars compromised by deep cavity of children between 5-9 years of age, of both sexes, are carefully selected and randomly assigned at random from among the following groups: Group I - Hydroxide Cement calcium, Group II - Mineral Trioxide Aggregate and Group III - Portland cement. Clinical and radiographic will be held at 6 and 12 months. Will use the chi-square test for intragroup comparisons will be adopted and 5% significance level for the differences are considered statistically significant. For outcomes will be considered a variation of at least 5% in clinical and radiographic assessments so that the differences are considered statistically significant.

Secondary

MeasureTime frame
The comparison of different materials for clinical treatment of deciduous teeth with deep caries. The evaluation will be use the materials: calcium hydroxide, cement mineral trioxide aggregate and portland cement from the clinical success of finding the observation period of 6 and 12 months. For outcomes will be considered a variation of at least 5% in clinical and radiographic assessments so that the differences are considered statistically significant.

Countries

Brazil

Contacts

Public ContactThiago Silva

Faculdade de Odontologia de Bauru

thiagocruvinel@fob.usp.br+55 (14) 981567225

Outcome results

None listed

Source: REBEC (via WHO ICTRP)