- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04195386
Efficacy of a Chemically Activated Composite Resin Alkasite in Atypical Caries Lesions of Deciduous Teeth
December 9, 2019 updated by: Jose Carlos P Imparato, Faculty Sao Leopoldo Mandic Campinas
Efficacy of a Chemically Activated Composite Resin Alkasite in Atypical Caries Lesions of Deciduous Teeth - Randomized Clinical Trial
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.
Study Overview
Status
Unknown
Conditions
Study Type
Interventional
Enrollment (Anticipated)
108
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
SP
-
Campinas, SP, Brazil, 13045-755
- Recruiting
- Faculdade Sao Leopoldo Mandic
-
Sub-Investigator:
- Ana Paula A Neves
-
Sub-Investigator:
- Carolina B Farina
-
Sub-Investigator:
- Jacqueline F de Paula
-
Sub-Investigator:
- Vanêssa F Alves
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Sub-Investigator:
- Anne Carolina Lima
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Sub-Investigator:
- Gabriela Santos
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Sub-Investigator:
- Juliana Camargo
-
Sub-Investigator:
- Thays Gisfrede
-
Sub-Investigator:
- Mariana Silva
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 7 years (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Chemically activated Composite resin Alkasite
Single placement of composite resin on atypical cavities.
|
Selective removal of dental caries with manual instruments, under relative isolation, application of universal adhesive system and restoration with chemically activated composite resin Alkasite.
|
ACTIVE_COMPARATOR: Resin-Modified Glass ionomer Cement
Single placement of Resin-Modified Glass ionomer Cement on atypical cavities.
|
Selective removal of dental caries with manual instruments, under relative isolation, application of polyacrylic acid and restoration with resin-modified glass ionomer cement.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survival of restoration
Time Frame: 12 months after treatment.
|
To evaluate the survival of restoration by clinical examination with FDI index.
|
12 months after treatment.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Caries lesion progression
Time Frame: 12 months after treatment.
|
For the evaluation of caries progression, the interproximal radiographic examination will be used to verify an increase of radiolucent image under restoration.
|
12 months after treatment.
|
Secondary caries lesion or on the surface adjacent to the restored tooth
Time Frame: 12 months after treatment.
|
Presence of caries lesion on the surface adjacent to the restored tooth or on the margins of the restoration by means of visualClinical Examination
|
12 months after treatment.
|
Perception of children and parents/guardians
Time Frame: 6 months after treatment.
|
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".
|
6 months after treatment.
|
Operator perception
Time Frame: 6 months after the restoration.
|
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.
|
6 months after the restoration.
|
Parents/Guardians Satisfaction
Time Frame: 6 months after restoration.
|
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.
|
6 months after restoration.
|
Child discomfort
Time Frame: Immediately after the treatment.
|
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.
|
Immediately after the treatment.
|
Post Operative sensitivity of the child
Time Frame: 7 ° day after the restorative procedure.
|
The child will also be questioned about the sensitivity of the restorative procedure.
For this, the Wong-Baker face scale will be used.
|
7 ° day after the restorative procedure.
|
Oral health-related quality of life
Time Frame: 6 month of restorative treatment.
|
The validated Brazilian version of Early Childhood Oral Health Impact Scale (ECOHIS) will be applied to children and should be answered by their parents.
|
6 month of restorative treatment.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 1, 2019
Primary Completion (ANTICIPATED)
January 30, 2020
Study Completion (ANTICIPATED)
January 30, 2021
Study Registration Dates
First Submitted
September 30, 2019
First Submitted That Met QC Criteria
December 9, 2019
First Posted (ACTUAL)
December 11, 2019
Study Record Updates
Last Update Posted (ACTUAL)
December 11, 2019
Last Update Submitted That Met QC Criteria
December 9, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SLM2990
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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