The aim of this study is to evaluate the efficacy of CTZ Paste in primary teeth, compared to endodontic treatment with Guedes-Pinto Paste. This is a multicenter, randomized, double-blind (patient), controlled and non-inferiority clinical study on 174 primary molars and 174 primary incisors of 3-6 years-old children with carious lesions with pulp involvement. The sample unit will be the tooth, which will be randomized into two groups. The teeth allocated to the experimental group will be treated with CTZ Paste, whereas the treatment of those teeth allocated to the control group will employ the Guedes-Pinto Paste. The procedures performed will be evaluated clinically and radiographically at 6 and 12 months. Secondary outcomes such as cost, discomfort, satisfaction and quality of life will also be evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
174
Tooth allocated to this group will be treated with CTZ paste, according to the Cappielo's protocol (1964), updated by Moura et al. (2016).
Tooth allocated to this group will be treated with Guedes-Pinto paste, according to the Guedes-Pinto's protocol (1981), updated by Mello-Moura et al. (2011).
Faculdade Sao Leopoldo Mandic
Campinas, São Paulo, Brazil
RECRUITINGClinical and radiographical efficacy of the endodontic treatment
The tooth will be evaluated according to the presence of mobility (yes or no) and regarding radiolucency area on initial and final radiography (measured and compared with the program ImageJ).
Time frame: 12 Months
Cost-efficacy
The costs of each treatment procedure will be calculated and compared with thresholds values for intervention cost-effectiveness by region, determined by World Health Organization (http://www.who.int/choice/costs/CER\_levels/en/). These values will be combined with the evaluated efficacy of the treatments (according description of Outcome 1).
Time frame: Through study completion (12 months)
Children's satisfaction with treatment
The satisfaction of each treatment will be evaluated using the Wong-Baker Facial Scale (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.
Time frame: Through study completion (12 months)
Parents/Guardians' satisfaction with children's treatment
The parents' satisfaction with each treatment will be evaluated using the Parent's Questionnaire about Teeth Appearance (Furtado et al., 2012).
Time frame: Through study completion (12 months)
Impact of treatment on children's quality of life
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 patients. The "Child Perceptions Questionnaire" (CPQ) will be used for 6-9 years old patients (Martins et al., 2009). The same questionnaire will be applied immediately before the procedure and on 12 months follow-up. Only one type of questionnaire will be used with each child, according to its age.
Time frame: Baseline and 12 months
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