Efficacy of a Chemically Activated Composite Resin Alkasite 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 Resin-Modified Glass ionomer Cement
Sponsored by
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
Inclusion Criteria:
• Children will be included who have at least one posterior tooth with atypical caries lesion.
Exclusion Criteria:
- 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.
Sites / Locations
- Faculdade Sao Leopoldo MandicRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Chemically activated Composite resin Alkasite
Resin-Modified Glass ionomer Cement
Arm Description
Single placement of composite resin on atypical cavities.
Single placement of Resin-Modified Glass ionomer Cement 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 visualClinical 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
NCT ID
NCT04195386
First Posted
September 30, 2019
Last Updated
December 9, 2019
Sponsor
Faculty Sao Leopoldo Mandic Campinas
1. Study Identification
Unique Protocol Identification Number
NCT04195386
Brief Title
Efficacy of a Chemically Activated Composite Resin Alkasite in Atypical Caries Lesions of Deciduous Teeth
Official Title
Efficacy of a Chemically Activated Composite Resin Alkasite in Atypical Caries Lesions of Deciduous Teeth - 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, 2021 (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 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.
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
Model Description
Compare the survival of restorations performed with chemically activated composite resin alkasite and resin- modified glass ionomer cement.
Masking
Participant
Allocation
Randomized
Enrollment
108 (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
Resin-Modified Glass ionomer Cement
Arm Type
Active Comparator
Arm Description
Single placement of Resin-Modified Glass ionomer Cement 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 Resin-Modified Glass ionomer Cement
Intervention Description
Selective removal of dental caries with manual instruments, under relative isolation, application of polyacrylic acid and restoration with resin-modified glass ionomer cement.
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 visualClinical 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 the restoration.
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 restoration.
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 ° day after the restorative procedure.
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 month of restorative 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
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.
Facility Information:
Facility Name
Faculdade Sao Leopoldo Mandic
City
Campinas
State/Province
SP
ZIP/Postal Code
13045-755
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose P Imparato, PhD
Phone
55193518-3600
Email
jimparato@usp.br
First Name & Middle Initial & Last Name & Degree
Ana Paula A Neves
First Name & Middle Initial & Last Name & Degree
Carolina B Farina
First Name & Middle Initial & Last Name & Degree
Jacqueline F de Paula
First Name & Middle Initial & Last Name & Degree
Vanêssa F Alves
First Name & Middle Initial & Last Name & Degree
Anne Carolina Lima
First Name & Middle Initial & Last Name & Degree
Gabriela Santos
First Name & Middle Initial & Last Name & Degree
Juliana Camargo
First Name & Middle Initial & Last Name & Degree
Thays Gisfrede
First Name & Middle Initial & Last Name & Degree
Mariana Silva
12. IPD Sharing Statement
Learn more about this trial
Efficacy of a Chemically Activated Composite Resin Alkasite in Atypical Caries Lesions of Deciduous Teeth
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