Efficacy of Sealing Molars: Split-mouth Randomized Clinical Trial
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|ClinicalTrials.gov Identifier: NCT03819868|
Recruitment Status : Recruiting
First Posted : January 29, 2019
Last Update Posted : January 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Dental Caries||Procedure: High cost Procedure: Low Cost||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Split-mouth|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Efficacy of Resin Sealing in Deciduous and Permanent Molars: Split-mouth Randomized Clinical Trial|
|Actual Study Start Date :||August 15, 2017|
|Estimated Primary Completion Date :||February 15, 2019|
|Estimated Study Completion Date :||December 2019|
Active Comparator: High Cost
Restoration using a high-cost sealant
Procedure: High cost
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
Procedure: Low Cost
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.
- 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:
- Present progression: Increased radiolucidity area of the Lesion
- Absent progression: No increase in the area of radiolucidity of the lesion.
- 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/).
- 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)
- 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.
- 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):
- Full retention: When the restorer material was Intact when subjected to clinical examination;
- Partial loss: When there was a loss of a part of the restorer material previously applied;
- Total Loss: When the restorer material has been lost in its entirety.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03819868
|Contact: Jose Carlos P Imparato, PhDfirstname.lastname@example.org|
|Faculty Sao Leopoldo Mandic||Recruiting|
|Campinas, Sao Paulo, Brazil, 13045755|
|Contact: Jose Carlos P Imparato, PhD +551935183601 email@example.com|