- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03819868
Efficacy of Sealing Molars: Split-mouth Randomized Clinical Trial
Efficacy of Resin Sealing in Deciduous and Permanent Molars: Split-mouth Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jose Carlos P Imparato, PhD
- Phone Number: +5511998686008
- Email: jimparato@usp.br
Study Locations
-
-
Sao Paulo
-
Campinas, Sao Paulo, Brazil, 13045755
- Recruiting
- Faculty Sao Leopoldo Mandic
-
Contact:
- Jose Carlos P Imparato, PhD
- Phone Number: +551935183601
- Email: jimparato@usp.br
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Children with at least two deciduous and/or permanent molars with occlusal caries lesions scores 1, 2 or 3 of the Icdas (Ismail et al., 2007) will be included, one on each side, preferably from the same arch.
Exclusion Criteria:
- Patients with special needs;
- using orthodontic appliances;
- with systemic diseases;
- Teeth that present restorations, sealants, formation defects, deep caries lesions that may lead to pulp impairment;
- teeth with fistula and/or abscess;
- teeth with spontaneous painful symptomatology.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: High Cost
Restoration using a high-cost sealant
|
Surfaces allocated to this group will be treated with a high-cost sealant (Fluroshield®, Dentsply, São Paulo, Brazil), according to the manufacturer's instructions.
|
Experimental: Low Cost
Restoration using a low-cost sealant
|
Surfaces allocated to this group will be treated with a low-cost sealant (Prevent®, FGM Produtos Odontológicos, Santa Catarina, Brazil), according to the manufacturer's instructions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dental caries progression
Time Frame: Every 6 months up to 18 months
|
Caries progression will be evaluated radiographically by three previously trained evaluators (through theoretical classes and evaluation of 13 clinical photographs) and calibrated. These examiners will not know the chronological order and compare the images two to two first by two evaluators and when there is disagreement between the two, the third examiner shall be called for tie-breaker. The possible progression of the treated caries lesion will be codified as:
|
Every 6 months up to 18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cost-effectiveness
Time Frame: 18 months
|
The costs of each treatment procedure will be calculated and compared with thresholds values for intervention costeffectiveness by region, determined by World Health Organization (http://www.who.int/choice/costs/CER_levels/en/).
|
18 months
|
Impact on children's quality of life
Time Frame: Baseline and 18 months
|
The oral health related quality of life will be measured using a validated questionnaire according to the children's age. The "Early Childhood Oral Health Impact Scale" (ECOHIS) (Tesch et al., 2008) will be applied with 4-5 years old children. The "Child Perceptions Questionnaire" (CPQ) will be used for 6-9 years old children (Martins et al., 2009). They will be applied immediately before the procedure and on 18 months follow-up and we will measure the difference between answers at baseline and the end of treatment (18months) |
Baseline and 18 months
|
Children self-reported discomfort
Time Frame: Baseline
|
The discomfort of each treatment will be evaluated using the facial scale of Wong-Baker (Wong, Baker, 1988).
The patient will be asked to choose the face that is more similar to how he/she felt during the treatment.
The answer should be given solely by the child, which means no parental or professional interferences.
Each face corresponds to a number, within a numeric scale from 0 to 5, with 0 no discomfort and 5 the greatest discomfort.
At the end, the averages of each score will be compared between the experimental groups.
|
Baseline
|
Sealant retention
Time Frame: Every 6 months up to 18 months
|
The elements submitted to the treatment will be codified in accordance with Hesse et al. (2012):
|
Every 6 months up to 18 months
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Wong DL, Baker CM. Pain in children: comparison of assessment scales. Pediatr Nurs. 1988 Jan-Feb;14(1):9-17. No abstract available.
- Hesse D, Bonifacio CC, Mendes FM, Braga MM, Imparato JC, Raggio DP. Sealing versus partial caries removal in primary molars: a randomized clinical trial. BMC Oral Health. 2014 May 28;14:58. doi: 10.1186/1472-6831-14-58.
- Martins MT, Ferreira FM, Oliveira AC, Paiva SM, Vale MP, Allison PJ, Pordeus IA. Preliminary validation of the Brazilian version of the Child Perceptions Questionnaire 8-10. Eur J Paediatr Dent. 2009 Sep;10(3):135-40.
- Tesch FC, Oliveira BH, Leao A. [Semantic equivalence of the Brazilian version of the Early Childhood Oral Health Impact Scale]. Cad Saude Publica. 2008 Aug;24(8):1897-909. doi: 10.1590/s0102-311x2008000800018. Portuguese.
- Pitts N, Melo P, Martignon S, Ekstrand K, Ismail A. Caries risk assessment, diagnosis and synthesis in the context of a European Core Curriculum in Cariology. Eur J Dent Educ. 2011 Nov;15 Suppl 1:23-31. doi: 10.1111/j.1600-0579.2011.00711.x.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SLM 5
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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