NCT04195386

Brief Summary

Atypical cavities, which involve more than two surfaces being one of them vestibular or lingual/palatine, are a challenge for restorative dentistry, since the risk of failure of the restorations are related to the number of surfaces involved. Thus, the objective of this project is to conduct a randomized clinical trial in order to evaluate the efficacy and patient-centered outcomes of a chemically-activated alkasite composite resin in atypical lesions of deciduous molars. Deciduous molars of children between 4 and 7 years of age with at least one atypical cavity lesion in deciduous molars will be selected for the ECR. The selected teeth will be randomly divided into two groups: Chemically activated composite resin Alkasite and resin-Modified glass ionomer cement. Clinical and radiographic follow-up of the lesions will be performed for 6 and 12 months. The efficacy of the treatments will be evaluated by the longevity of the restoring procedures and the arrestment of the caries lesions. Patient-centered outcomes will also be evaluated.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 11, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2021

Completed
Last Updated

December 11, 2019

Status Verified

December 1, 2019

Enrollment Period

5 months

First QC Date

September 30, 2019

Last Update Submit

December 9, 2019

Conditions

Dental Caries in Children

Keywords

Dental cariesDeciduous teethPermanent dental restoration

Outcome Measures

Primary Outcomes (1)

  • Survival of restoration

    To evaluate the survival of restoration by clinical examination with FDI index.

    12 months after treatment.

Secondary Outcomes (8)

  • Caries lesion progression

    12 months after treatment.

  • Secondary caries lesion or on the surface adjacent to the restored tooth

    12 months after treatment.

  • Perception of children and parents/guardians

    6 months after treatment.

  • Operator perception

    6 months after the restoration.

  • Parents/Guardians Satisfaction

    6 months after restoration.

  • +3 more secondary outcomes

Study Arms (2)

Chemically activated Composite resin Alkasite

EXPERIMENTAL

Single placement of composite resin on atypical cavities.

Procedure: Dental Restoration with Chemically activated Composite resin Alkasite

Resin-Modified Glass ionomer Cement

ACTIVE COMPARATOR

Single placement of Resin-Modified Glass ionomer Cement on atypical cavities.

Procedure: Dental Restoration with Resin-Modified Glass ionomer Cement

Interventions

Dental Restoration with Chemically activated Composite resin AlkasitePROCEDURE

Selective removal of dental caries with manual instruments, under relative isolation, application of universal adhesive system and restoration with chemically activated composite resin Alkasite.

Chemically activated Composite resin Alkasite
Dental Restoration with Resin-Modified Glass ionomer CementPROCEDURE

Selective removal of dental caries with manual instruments, under relative isolation, application of polyacrylic acid and restoration with resin-modified glass ionomer cement.

Resin-Modified Glass ionomer Cement

Eligibility Criteria

Age4 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children will be included who have at least one posterior tooth with atypical caries lesion.

You may not qualify if:

  • Patients with special needs
  • Patients general health conditions that may affect the oral cavity
  • Patients non-cooperating in relation to the examination
  • Patients with orthodontic apparatus
  • The parents/guardians or children not to consent to their participation in the study.
  • Teeth with pulp exposure
  • Teeth with spontaneous pain
  • Teeth with mobility
  • Teeth with presence of swelling or fistula close to the tooth
  • Teeth with furcation or cervical injury
  • Teeth with restorations, sealants or enamel formation defects will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculdade Sao Leopoldo Mandic

Campinas, São Paulo, 13045-755, Brazil

RECRUITING

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Compare the survival of restorations performed with chemically activated composite resin alkasite and resin- modified glass ionomer cement.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD in Pediatric Dentistry

Study Record Dates

First Submitted

September 30, 2019

First Posted

December 11, 2019

Study Start

September 1, 2019

Primary Completion

January 30, 2020

Study Completion

January 30, 2021

Last Updated

December 11, 2019

Record last verified: 2019-12

Locations

BR(1)