Endodontic Treatment Using CTZ Paste in Primary Teeth

NCT03731975 | Unknown

• 1 other identifier: SLM4
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulpectomy Agents

Keywords

Tooth, deciduous; Pulp Capping and Pulpectomy Agents; Pulpectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Cost-efficacy

  Through study completion (12 months)

• Children's satisfaction with treatment

  Through study completion (12 months)

• 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

Study Arms (2)

CTZ Paste

ACTIVE COMPARATOR

Endodontic treatment with CTZ paste.

Procedure: CTZ Paste

GP Paste

EXPERIMENTAL

Endodontic treatment with Guedes-Pinto paste.

Procedure: GP Paste

Interventions

CTZ Paste PROCEDURE

Tooth allocated to this group will be treated with CTZ paste, according to the Cappielo's protocol (1964), updated by Moura et al. (2016).

CTZ Paste

GP Paste PROCEDURE

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).

GP Paste

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Faculty Sao Leopoldo Mandic Campinas: lead

Study Sites (1)

Faculdade Sao Leopoldo Mandic

Campinas, São Paulo, 13045-755, Brazil

RECRUITING

Related Publications (7)

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

  BACKGROUND

• 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.

  PMID: 27472562 BACKGROUND

• 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.

  PMID: 22892969 BACKGROUND

• 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.

  PMID: 6943625 BACKGROUND

• 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.

  PMID: 22484870 BACKGROUND

• 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.

  PMID: 20002630 BACKGROUND

• 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.

  PMID: 11291631 BACKGROUND

Central Study Contacts

Jose Imparato, Dr

CONTACT

+551130851046; jimparato@usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: October 25, 2018
• First Posted: November 6, 2018
• Study Start: July 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: December 24, 2018

Record last verified: 2018-12

Locations

BR (1)