Ultraconservative Caries Treatment in Anterior Cavitated Caries Lesion of Primary Teeth (CEPECO2)
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|ClinicalTrials.gov Identifier: NCT03785730|
Recruitment Status : Suspended (Outbreak of COVID-19.)
First Posted : December 24, 2018
Last Update Posted : June 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Dental Caries||Procedure: UCT Procedure: Restoration with composite resin||Not Applicable|
This is a randomized controlled, two-arms parallel-group (1:1) trial. Initially, it will be submitted to the Research Ethics Committee of the Ibirapuera University - UNIB. The other centers involved will be considered as co-participants (Santa Cecilia University - UNISANTA and Uninovafapi University Center - UNINOVAFAPI). Only those patients who meet the eligibility criteria will be included in the study after signing the Informed Consent Form by the parents and the child's assent to study participation.
In order to carry out the sample calculation, the expected survival for the primary teeth with cavitated lesions on the proximal surface submitted to ultraconservative treatments is 89.7% after a period of 24 months (Mijan et al., 2014). Thus, a clinically significant difference is expected to be 20% in the success rate between the groups. With this, adopting a level of significance of 0.05 and a power of 0.80, we reached the number of 136 patients. Since each child can contribute more than one tooth, 20% was added to that value (cluster per child), and 20% due to a possible sample loss. Thus, the final rounded number of 98 teeth per group resulted in 196 teeth in total (MedCalc version 15.8, Ostend, BE).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||196 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impact of Ultraconservative Caries Treatment in Anterior Cavitated Caries Lesion of Primary Teeth on Survival of Teeth and Patient-reported Outcomes - Randomized Clinical Trial|
|Actual Study Start Date :||April 30, 2019|
|Estimated Primary Completion Date :||December 30, 2020|
|Estimated Study Completion Date :||April 30, 2022|
Enlargement of the wells with metal sandpaper.
In the experimental group, the treatment will be performed after prophylaxis and relative isolation. The cavitated caries lesion will be widened with the aid of a metal sandpaper to facilitate the removal of the biofilm.
Active Comparator: Restoration with composite resin
Selective caries removal and restoration with composite resin.
Procedure: Restoration with composite resin
In control group, the treatment will be performed after prophylaxis and relative isolation. The selective caries removal will be performed with appropriate dentin curettes, and then the application of the adhesive system and restoration of composite resin will be conducted.
- Tooth survival by clinical assessment [ Time Frame: 24 months ]Comparing the survival of teeth treated with restoration of composite resin and with UTC for lesions cavitated in anterior primary teeth by clinical assessment, considering the presence of tooth in the cavity without the need for a new treatment.
- Discomfort regarding the treatment options by a Face image scale (FIS) [ Time Frame: Immediately after treatment ]Children-reported discomfort regarding the treatment options by a Face image scale (FIS). The scale present 5 different faces since "very happy" (scored as 1) until "very sad" (scored as 5) with the treatment. Higher scores mean a worse discomfort.
- Cost-efficacy analysis [ Time Frame: 24 months. ]The duration of the treatments (time of treatment) and the cost of the materials used will be considered for the estimation of the cost-efficacy of the treatments by a ratio - cost/efficacy, being efficacy considered the tooth survival.
- Perception of parents / guardians evaluated through questionnaire [ Time Frame: Prior to treatment, immediately after and 6 months later. ]Parents perception of the treatments will be evaluated through a questionnaire - "Child's and parent's questionnaire about teeth appearance" - with possible answers varying from very satisfied until insatisfied. After the questionnaire is applied for the parents/guardians, the anwsers will bem transformed in scores 1 to 5, in according the original paper that validated the questionnaire. Higher scores mean a worse perception.
- Satisfaction of children: questionnaire [ Time Frame: After 6 months ]Children-reported satisfaction regarding the treatment by a questionnaire with five question which for answers will be used a Face image scale (FIS). The scale present 5 different faces since "very happy" (scored as 1) until "very sad" (scored as 5) with the treatment. Lower scores mean a better satisfaction.
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): NCT03785730
|Tamara Kerber Tedesco|
|São Paulo, SP, Brazil, 04.545-000|