Efficacy of Endodontic Treatment Using CTZ Paste in Primary Teeth: Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Sponsor
- Faculty Sao Leopoldo Mandic Campinas
- Enrollment
- 174
- Locations
- 1
- Primary Endpoint
- Clinical and radiographical efficacy of the endodontic treatment
Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 3 Years to 6 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Clinical and radiographical efficacy of the endodontic treatment
Time Frame: 12 Months
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).
Secondary Outcomes
- Parents/Guardians' satisfaction with children's treatment(Through study completion (12 months))
- Impact of treatment on children's quality of life(Baseline and 12 months)
- Cost-efficacy(Through study completion (12 months))
- Children's satisfaction with treatment(Through study completion (12 months))
Investigators
Jose Carlos P Imparato
Principal Investigator, Clinical Professor
Faculty Sao Leopoldo Mandic Campinas