NCT04195022

Brief Summary

Atypical cavities, which involve more than two surfaces, one being buccal or lingual/palatal, are a challenge for restorative dentistry, since the risk of restorative failure is related to the number of surfaces involved. Thus, the purpose of this umbrella project is to conduct a randomized controlled trial (RCT) to evaluate the efficacy and patient-centered outcomes of a chemically activated composite alkasite resin in atypical deciduous molar lesions. Primary molars of children aged 4 to 7 years with at least one atypical cavitary lesion in primary molars will be selected for the RCT. The selected teeth will be randomly divided into: Alkasite chemically activated composite resin and Bulk fill composite resin. Clinical and radiographic follow-up of the lesions will be performed for 6 and 12 months. The effectiveness of the treatments will be evaluated by the longevity of the restorative procedures and paralysis of the 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
162

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

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
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2020

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 treatment.

  • Parents/Guardians Satisfaction

    6 months after treatment.

  • +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

Bulk fill resin composite

ACTIVE COMPARATOR

Single placement of Bulk fill resin composite on atypical cavities.

Procedure: Dental Restoration with Bulk fill resin composite

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 Bulk fill resin compositePROCEDURE

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

Bulk fill resin composite

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 will be excluded, with general health conditions that may affect the oral cavity, non-cooperating in relation to the examination, which use orthodontic apparatus and the parents/guardians or children not to consent to their participation in the study. In addition, teeth with pulp exposure, spontaneous pain, mobility, presence of swelling or fistula close to the tooth, 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)

Faculty Sao Leopoldo Mandic

Campinas, São Paulo, 13045755, 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

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, 2020

Last Updated

December 11, 2019

Record last verified: 2019-12

Locations

BR(1)