Skip to content

Survival analysis of glass ionomer cement restorations after carious tissue removal using or not Brix3000: randomized controlled clinical trial

Survival analysis of glass ionomer cement restorations after removal of carious tissue using or not using Brix 3000: Randomized controlled clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-85jmbs
Enrollment
Unknown
Registered
2020-01-29
Start date
2019-09-28
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, Papain, dental materials, pediatric dentistry

Interventions

For each participant, at least one eligible decayed molar is presented. After identifying the elements to be included, which will be a total of 136, within each group (68 in all), each patient will be
H02.163.876.600

Sponsors

Universidade Federal do Rio de Janeiro
Lead Sponsor
Universidade Federal do Rio de Janeiro
Collaborator

Eligibility

Age
3 Years to 9 Years

Inclusion criteria

Inclusion criteria: 3- to 9-year-old male and female patients without ethnic restriction;Patients with behavior considered definitely positive or positive according to the Frankl scale;Patients with at least one carious lesions active in deciduous molars reaching only the occlusal surface, not exceeding 2/3 of the dentin and without cusp involvement;Patients without clinical and radiographic evidence of pulp involvement in the molars selected for the study;

Exclusion criteria

Exclusion criteria: Patients with systemic impairment;deciduous molars with carious Black Class II lesions; deciduous molars with inactive or incipient enamel caries lesions; deciduous molars unable to be restored; deciduous molars with more than 2/3 of resorbed root;Deciduous molars with mobility due to physiological rhizolysis.

Design outcomes

Primary

MeasureTime frame
Difference in survival of restorations performed after using the caries removal technique (ART) associated or not with chemical-mechanical removal observed through clinical evaluations using the USPHS method at 3, 6, 9 and 12 months after treatment and radiographic evaluation 1 year after treatment

Secondary

MeasureTime frame
The working time after using the TRA technique associated with chemical-mechanical removal with Brix3000 and the working time after using only the TRA technique will be accounted for using a standardized timer and statistical differences between the two techniques will be analyzed.;The acceptability of children in relation to the techniques of treatment of caries injuries TRA and TRA associated with chemical-mechanical removal will be assessed by applying a questionnaire with a hedonic scale to the children after the end of treatment.;The experience of pain during the use of techniques for the treatment of caries injuries will be assessed by applying the FLACC-r scale during treatment by an evaluator who is blind to the type of treatment being performed on the child, who will observe the child throughout the treatment.;Difference between treatment techniques regarding the progression of carious lesions will be analyzed by comparing computerized radiographs taken immediately after the end of treatment and after 1 year.

Countries

Brazil

Contacts

Public ContactTainá de Souza

Universidade Federal do Rio de Janeiro

TainaFsouza15@hotmail.com+55-021-99841-4474

Outcome results

None listed

Source: REBEC (via WHO ICTRP)