Clinical trial NCT03731975: Endodontic Treatment Using CTZ Paste in Primary Teeth
Official title: Efficacy of Endodontic Treatment Using CTZ Paste in Primary Teeth: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulpectomy Agents
Keywords: Tooth, deciduous
Pulp Capping and Pulpectomy Agents
Pulpectomy
Lead sponsor: Faculty Sao Leopoldo Mandic Campinas
Sponsor class: OTHER
First posted: 2018-11-06
Enrollment: 174
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Clinical and radiographical efficacy of the endodontic treatment
timeFrame: 12 Months
Secondary outcomes:
measure: Cost-efficacy
timeFrame: Through study completion (12 months)
measure: Children's satisfaction with treatment
timeFrame: Through study completion (12 months)
measure: Parents/Guardians' satisfaction with children's treatment
timeFrame: Through study completion (12 months)
measure: Impact of treatment on children's quality of life
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Faculdade Sao Leopoldo Mandic
state: SP
Study officials:
References:
citation: Cappiello J. Tratamientos pulpares en incisivos primários. Rev Circ Od Ros 1964;52(4):133-45.
citation: de Deus Moura Lde F, de Lima Mde D, Lima CC, Machado JI, de Moura MS, de Carvalho PV. Endodontic Treatment of Primary Molars with Antibiotic Paste: A Report of 38 Cases. J Clin Pediatr Dent. 2016;40(3):175-7. doi: 10.17796/1053-4628-40.3.175.
citation: Furtado GE, Sousa ML, Barbosa TS, Wada RS, Martinez-Mier EA, Almeida ME. [Perceptions of dental fluorosis and evaluation of agreement between parents and children: validation of a questionnaire]. Cad Saude Publica. 2012 Aug;28(8):1493-505. doi: 10.1590/s0102-311x2012000800008. Portuguese.
citation: Guedes-Pinto AC, De Paiva JG, Bozzola JR. [Endodontic treatment of deciduous teeth with pulp necrosis]. Rev Assoc Paul Cir Dent. 1981 May-Jun;35(3):240-4. No abstract available. Portuguese.
citation: Mello-Moura AC, Fanaro J, Nicoletti MA, Mendes FM, Wanderley MT, Guedes-Pinto AC. Variability in the proportion of components of iodoform-based Guedes-Pinto paste mixed by dental students and pediatric dentists. Indian J Dent Res. 2011 Nov-Dec;22(6):781-5. doi: 10.4103/0970-9290.94668.
citation: Monse B, Heinrich-Weltzien R, Benzian H, Holmgren C, van Palenstein Helderman W. PUFA--an index of clinical consequences of untreated dental caries. Community Dent Oral Epidemiol. 2010 Feb;38(1):77-82. doi: 10.1111/j.1600-0528.2009.00514.x. Epub 2009 Dec 7.
citation: Wong DL, Baker CM. Smiling faces as anchor for pain intensity scales. Pain. 2001 Jan;89(2-3):295-300. doi: 10.1016/s0304-3959(00)00375-4. No abstract available.