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Root Canal Treatment in Primary Molars With Necrotic Pulp Using Two Different Pulp Therapies

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ClinicalTrials.gov Identifier: NCT03650036
Recruitment Status : Recruiting
First Posted : August 28, 2018
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Lucia de Fatima Almeida de Deus Moura, Federal University of Piaui

Brief Summary:

This is a controlled, randomized, double-blind clinical study (researcher and research participant does not know which group they belong to), with the objective of evaluating clinical and radiographic performances of primary molar canal treatments with necrotic pulps using two obturator pulps. The CTZ paste (composed of chloramphenicol, tetracycline, zinc oxide and eugenol) and the ZOE paste (composed of zinc oxide and eugenol). The CTZ paste represents an alternative treatment that makes possible to treat canals of primary molars in a simplified way, without instrumentation of root canals. Studies with the CTZ pulp have demonstrated satisfactory clinical and radiographic results in addition to biocompatibility and good antimicrobial action. The zinc oxide and eugenol paste has been studied, presents good clinical and radiographic results, it is indicated by the American Academy of Paediatric Dentistry and requires mechanical chemical preparation of the root canals.

Children of both sexes, frequenters of the paediatric dentistry clinic of the Federal University of Piaui who present lower deciduous molars with clinical history and / or radiographic evidences of pulp necrosis will participate in the study.

The hypothesis of the study is that both pastes present similar clinical and radiographic results.


Condition or disease Intervention/treatment Phase
Dental Pulp Necrosis Drug: Pulp Therapy CTZ Paste Drug: Pulp Therapy ZOE Paste Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The patients will be allocated into two groups and will remain in the group until the end of the experiment.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: The clinical evaluations will be performed by two Paediatric Dentists who will not participate in the clinical part and will not know which group the teeth belong to. Participants also will not know in which group they will be allocated.
Primary Purpose: Treatment
Official Title: Pulp Therapy in Necrotic Primary Molars Using CTZ Paste and Zinc Oxide-Eugenol Paste - a Randomized Controlled Clinical Trial
Actual Study Start Date : June 4, 2018
Estimated Primary Completion Date : December 21, 2018
Estimated Study Completion Date : June 4, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1
In group 1, Pulp Therapy will be done with the CTZ paste (composed of 62.5 mg of chloramphenicol, 62.5 mg of tetracycline, 125 mg of zinc oxide) will be manipulate with 0.1ml of eugenol in a sterile glass plate with flexible metal spatula at the time of use and will be taken at the tip of a number 5 exploratory probe and dispensed at the entrances of the root canals where it will be accommodated with light pressure of sterile cotton balls. The CTZ paste will be protected with a thin layer of gutta-percha, previously heated in an alcohol lamp and placed in a thin layer on the CTZ pulp. The gutta-percha blade will be condensed with medium size amalgam presser and has the objective of physically isolating the CTZ paste from the restorative material.
Drug: Pulp Therapy CTZ Paste
CTZ paste is composed of 62.5 mg of chloramphenicol, 62.5 mg of tetracycline and 125 mg of zinc oxide and manipulated with 0.1ml of eugenol in a sterile glass plate with flexible metal spatula at the time of use.
Other Name: Endodontic Treatment

Experimental: Group 2
In Group 2, Pulp Therapy will be done with ZOE paste. The mechanical preparation of the root canals with 2% chlorhexidine solution and first-series K files will be performed. The instrumentation limit shall be 1 mm short of the radiographic apex. After finishing the chemical-mechanical preparation, drying of the root canals with sterile absorbent paper cones and ZOE paste insertion with K files will be performed. The zinc oxide of the ZOE paste will be supplied in 250mg capsules and handled with 0.1ml eugenol in a sterile glass plate with metal spatula at the time of use. The protection of the ZOE paste will follow the same sequence as the CTZ paste.
Drug: Pulp Therapy ZOE Paste
The zinc oxide of the ZOE paste will be supplied in 250mg capsules and handled with 0.1ml eugenol in a sterile glass plate with metal spatula at the time of use.
Other Name: Endodontic Treatment




Primary Outcome Measures :
  1. Infection control of deciduous molars with necrotic pulp by clinical examination [ Time Frame: up to 36 months ]
    The methods used to evaluate the primary outcome involved clinical evaluation. Clinical evaluation will be carried out by two Pediatric Dentists who did not participate in the project and blind to which group the teeth belong to and if there is a discrepancy in evaluations, a third evaluator will be called. When there are absences of reports of pain, abscess and mobility incompatible with chronological age at the times evaluated will be considered clinical success.

  2. Infection control of deciduous molars with necrotic pulp by Radiographic examination [ Time Frame: up to 36 months ]
    The methods used to evaluate the primary outcome involved radiographic evaluation. Radiographic evaluations will be performed by two Dental Radiologists, who did not participate in the study. Radiographic success will be evidenced by the regression or absence of radiolucency in the interradicular region and absence of pathological root resorptions.


Secondary Outcome Measures :
  1. 1. The improvement in the Quality of life of children after pulp therapy using a questionnaire [ Time Frame: Three months after pulp therapy. ]
    The Brazilian version of the Early Childhood Oral Health Impact Scale (B-ECOHIS) will be applicated for parents of children with pulp necrosis before and after pulp therapy for evaluate quality of life these children and their families after execution of the treatment. The ECOHIS consists of 13 questions divided into two main parts: child impact section (part one) and family impact section (part two). The child impact section comprises of four subscales: child symptom, child function, child psychology and child self-image/social interaction. The family impact section contains two subscales: parental distress and family function. The questionnaire is scored using a simple five-point Likert scale with responses ranging from "never" to "very often" (equivalent to a score of 0 and 4, respectively). A total score ranging from zero to 52 is calculated as a simple sum of the responses with higher scores denoting a greater oral health impact and/or poorer quality of life.



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Ages Eligible for Study:   3 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Lower primary molars with clinical and / or radiographic history of pulp necrosis.
  • Crown with sufficient dental structure to be restored with stainless steel crown.
  • Rhizolysis equal to or less than 1/3.

Exclusion Criteria:

  • Teeth that present calcium metamorphosis.
  • Pathological root resorption.
  • Coronary destruction that makes it impossible for the tooth to be restored.
  • You have been using antibiotics for the last three months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03650036


Contacts
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Contact: Lúcia Moura, Professor +55-086 3237 1517 mouraiso@uol.com.br
Contact: Marina Lima, Professor +55-086 3237 1517 mdmlima@gmail.com

Locations
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Brazil
Federal University of Piaui Recruiting
Teresina, Piaui, Brazil, 64.049-550
Contact: Lúcia Moura, Professor    +55-086 3237 1517    mouraiso@uol.com.br   
Contact: Marina Lima, Professor    +55-086 3237 1517    mdmlima@gmail.com   
Sponsors and Collaborators
Federal University of Piaui
Investigators
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Principal Investigator: Lúcia Moura, Professor Federal University of Piaui

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Responsible Party: Lucia de Fatima Almeida de Deus Moura, Full professor at Federal University of Piaui Dentistry course, Federal University of Piaui
ClinicalTrials.gov Identifier: NCT03650036     History of Changes
Other Study ID Numbers: Ppgo2018
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lucia de Fatima Almeida de Deus Moura, Federal University of Piaui:
Primary teeth
Dental Pulp Necrosis
Root Canal Obturation

Additional relevant MeSH terms:
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Necrosis
Dental Pulp Necrosis
Pathologic Processes
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases
Zinc Oxide
Eugenol
Dermatologic Agents
Sunscreening Agents
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents