Endodontic Treatment Using CTZ Paste in Primary Teeth

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Endodontic Treatment Using CTZ Paste in Primary Teeth: Randomized Clinical Trial

Conditions
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Pulpectomy Agents

Intervention / Treatment
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* Procedure: CTZ Paste
* Procedure: GP Paste


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children aged from 3 to 6 years and 11 months; children present at least one upper or lower molar or primary upper incisor with untreated carious lesion with pulp envelopment; children assent to participate in the study through collaborative behavior; children's parents/guardians consent to their participation by signing the Informed Consent Form (ICF). Exclusion Criteria: tooth with carious lesion involving three or more dental surfaces, making the restoration extremely difficult or impossible; tooth with internal or external resorption in more than 1/3 of the root length; tooth whose crypt of the successor permanent is affected; tooth which have less than 2/3 of the root; patients who present health problems with oral impairment.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CTZ Paste<br>Endodontic treatment with CTZ paste. | Procedure: CTZ Paste<br>* Tooth allocated to this group will be treated with CTZ paste, according to the Cappielo's protocol (1964), updated by Moura et al. (2016).<br>|
| Experimental: GP Paste<br>Endodontic treatment with Guedes-Pinto paste. | Procedure: GP Paste<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical 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). | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | 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). | 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. | Baseline and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tooth, deciduous, Pulp Capping and Pulpectomy Agents, Pulpectomy