Root Canal Treatment in Primary Molars With Necrotic Pulp Using Two Different Pulp Therapies
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03650036|
Recruitment Status : Active, not recruiting
First Posted : August 28, 2018
Last Update Posted : July 30, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||86 participants|
|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.|
|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|
|Actual Primary Completion Date :||May 21, 2019|
|Estimated Study Completion Date :||June 4, 2021|
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
- 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.
- 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.
- 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.
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
|Federal University of Piaui|
|Teresina, Piaui, Brazil, 64.049-550|
|Principal Investigator:||Lúcia Moura, Professor||Federal University of Piaui|