Endodontic Treatment Using CTZ Paste in Primary Teeth (SLM2204)

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

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 Overview

• Status: Unknown
• Conditions: Pulpectomy Agents
• Intervention / Treatment: Procedure: CTZ Paste; Procedure: GP Paste

• Study Type: Interventional
• Enrollment (Anticipated): 174
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jose Imparato, Dr; Phone Number: +551130851046; Email: jimparato@usp.br

Study Locations

• Brazil
  • SP
    • Campinas, SP, Brazil, 13045-755
      • Recruiting
      • Faculdade Sao Leopoldo Mandic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Faculty Sao Leopoldo Mandic Campinas

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• Cappiello J. Tratamientos pulpares en incisivos primários. Rev Circ Od Ros 1964;52(4):133-45.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): December 1, 2018
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: October 25, 2018
• First Submitted That Met QC Criteria: November 5, 2018
• First Posted (Actual): November 6, 2018

Study Record Updates

• Last Update Posted (Actual): December 24, 2018
• Last Update Submitted That Met QC Criteria: December 21, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Pulpectomy; Tooth, deciduous; Pulp Capping and Pulpectomy Agents
• Other Study ID Numbers: SLM4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No