Endodontic Treatment Using CTZ Paste in Primary Teeth (SLM2204)

Faculty Sao Leopoldo Mandic Campinas

Status: Unknown

Conditions: Pulpectomy Agents

Treatments: Procedure: CTZ Paste; Procedure: GP Paste

Study type: Interventional

Funder types: Other

Identifiers

NCT03731975

SLM4

Details and patient eligibility

About

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.

Enrollment: 174 estimated patients

Sex: All

Ages: 3 to 6 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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174 participants in 2 patient groups

CTZ Paste

Active Comparator group

Description:

Endodontic treatment with CTZ paste.

Treatment:

Procedure: CTZ Paste

GP Paste

Experimental group

Description:

Endodontic treatment with Guedes-Pinto paste.

Treatment:

Procedure: GP Paste