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Comparison of a Chemically Activated Composite Resin Alkasite With Resin Composite in Atypical Caries Lesions of Deciduous Teeth

Primary Purpose

Dental Caries in Children

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Dental Restoration with Chemically activated Composite resin Alkasite
Dental Restoration with Bulk fill resin composite
Sponsored by
Faculty Sao Leopoldo Mandic Campinas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries in Children focused on measuring Dental caries, Deciduous teeth, Permanent dental restoration

Eligibility Criteria

4 Years - 7 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Faculty Sao Leopoldo MandicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Chemically activated Composite resin Alkasite

Bulk fill resin composite

Arm Description

Single placement of composite resin on atypical cavities.

Single placement of Bulk fill resin composite on atypical cavities.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Caries lesion progression
For the evaluation of caries progression, the interproximal radiographic examination will be used to verify an increase of radiolucent image under restoration.
Secondary caries lesion or on the surface adjacent to the restored tooth
Presence of caries lesion on the surface adjacent to the restored tooth or on the margins of the restoration by means of visual Clinical Examination.
Perception of children and parents/guardians
To evaluate the satisfaction of the children in relation to the treatment performed. The questionnaire will be used "Child's and parent's questionnaire about teeth appearance".
Operator perception
It will be employed a questionnaire after the completion of the treatment performed. It will also be added a question about the behavior of children during the procedure, which will be categorized as - great behavior, regular or bad.
Parents/Guardians Satisfaction
The parents/guardians will be questioned about the satisfaction regarding the treatment performed in the child. The answer will be scored by a likert scale.
Child discomfort
The child will also be questioned as to the discomfort in relation to the treatment performed. For this will be used the scale of faces of Wong-Baker.
Post Operative sensitivity of the child
The child will also be questioned about the sensitivity of the restorative procedure. For this, the Wong-Baker face scale will be used.
Oral health-related quality of life
The validated Brazilian version of Early Childhood Oral Health Impact Scale (ECOHIS) will be applied to children and should be answered by their parents.

Full Information

First Posted
September 30, 2019
Last Updated
December 9, 2019
Sponsor
Faculty Sao Leopoldo Mandic Campinas
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1. Study Identification

Unique Protocol Identification Number
NCT04195022
Brief Title
Comparison of a Chemically Activated Composite Resin Alkasite With Resin Composite in Atypical Caries Lesions of Deciduous Teeth
Official Title
Comparison of a Chemically Activated Composite Resin Alkasite With Resin Composite in Atypical Caries Lesions of Deciduous Teeth - A Non-inferiority Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
January 30, 2020 (Anticipated)
Study Completion Date
January 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Faculty Sao Leopoldo Mandic Campinas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries in Children
Keywords
Dental caries, Deciduous teeth, Permanent dental restoration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
162 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chemically activated Composite resin Alkasite
Arm Type
Experimental
Arm Description
Single placement of composite resin on atypical cavities.
Arm Title
Bulk fill resin composite
Arm Type
Active Comparator
Arm Description
Single placement of Bulk fill resin composite on atypical cavities.
Intervention Type
Procedure
Intervention Name(s)
Dental Restoration with Chemically activated Composite resin Alkasite
Intervention Description
Selective removal of dental caries with manual instruments, under relative isolation, application of universal adhesive system and restoration with chemically activated composite resin Alkasite.
Intervention Type
Procedure
Intervention Name(s)
Dental Restoration with Bulk fill resin composite
Intervention Description
Selective removal of dental caries with manual instruments, under relative isolation, application of universal adhesive system and restoration with bulk fill resin composite.
Primary Outcome Measure Information:
Title
Survival of restoration
Description
To evaluate the survival of restoration by clinical examination with FDI index.
Time Frame
12 months after treatment.
Secondary Outcome Measure Information:
Title
Caries lesion progression
Description
For the evaluation of caries progression, the interproximal radiographic examination will be used to verify an increase of radiolucent image under restoration.
Time Frame
12 months after treatment.
Title
Secondary caries lesion or on the surface adjacent to the restored tooth
Description
Presence of caries lesion on the surface adjacent to the restored tooth or on the margins of the restoration by means of visual Clinical Examination.
Time Frame
12 months after treatment.
Title
Perception of children and parents/guardians
Description
To evaluate the satisfaction of the children in relation to the treatment performed. The questionnaire will be used "Child's and parent's questionnaire about teeth appearance".
Time Frame
6 months after treatment.
Title
Operator perception
Description
It will be employed a questionnaire after the completion of the treatment performed. It will also be added a question about the behavior of children during the procedure, which will be categorized as - great behavior, regular or bad.
Time Frame
6 months after treatment.
Title
Parents/Guardians Satisfaction
Description
The parents/guardians will be questioned about the satisfaction regarding the treatment performed in the child. The answer will be scored by a likert scale.
Time Frame
6 months after treatment.
Title
Child discomfort
Description
The child will also be questioned as to the discomfort in relation to the treatment performed. For this will be used the scale of faces of Wong-Baker.
Time Frame
Immediately after the treatment.
Title
Post Operative sensitivity of the child
Description
The child will also be questioned about the sensitivity of the restorative procedure. For this, the Wong-Baker face scale will be used.
Time Frame
7 days after treatment.
Title
Oral health-related quality of life
Description
The validated Brazilian version of Early Childhood Oral Health Impact Scale (ECOHIS) will be applied to children and should be answered by their parents.
Time Frame
6 months after treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Children will be included who have at least one posterior tooth with atypical caries lesion. Exclusion Criteria: 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.
Facility Information:
Facility Name
Faculty Sao Leopoldo Mandic
City
Campinas
State/Province
Sao Paulo
ZIP/Postal Code
13045755
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Carlos P Imparato, PhD
Phone
+551935183601
Email
jimparato@usp.br
First Name & Middle Initial & Last Name & Degree
Ana Paula M de Araújo
First Name & Middle Initial & Last Name & Degree
Bruno P de Posses
First Name & Middle Initial & Last Name & Degree
Débora S Dionísio
First Name & Middle Initial & Last Name & Degree
Jaqueline M Salviogni
First Name & Middle Initial & Last Name & Degree
Lis T Meneghel
First Name & Middle Initial & Last Name & Degree
Malvina S Pereira
First Name & Middle Initial & Last Name & Degree
Mayra de Jesus
First Name & Middle Initial & Last Name & Degree
Naiara S de Almeida
First Name & Middle Initial & Last Name & Degree
Patrícia S Marzarotto

12. IPD Sharing Statement

Learn more about this trial

Comparison of a Chemically Activated Composite Resin Alkasite With Resin Composite in Atypical Caries Lesions of Deciduous Teeth

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