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Clinical Trials/NCT03488316
NCT03488316
Unknown
Not Applicable

Influence of Temporary Filling Material Composition on the Success Rate of Endodontic Treatments - Randomized Clinical Study

PAULO VINICIUS SOARES1 site in 1 country20 target enrollmentMay 1, 2018

Overview

Phase
Not Applicable
Intervention
Definiteve canal root obturation
Conditions
MTA
Sponsor
PAULO VINICIUS SOARES
Enrollment
20
Locations
1
Primary Endpoint
Contamination rate of endodontically treated teeth that required filling with temporary material with a 1 year follow up.
Last Updated
8 years ago

Overview

Brief Summary

The aim of this study is through a randomized clinical trial, double blind, splitmouth, evaluate the success rate (contamination rate, periapical lesion relapse and the presence of exudate between the treatment's sessions) of endodontically treated teeth that required filling with temporary material. The composition of the temporary filling material (cement (Based on calcium hydroxide; and based on mineral trioxide aggregate) will be evaluated. Data will be collected, tabulated and submitted to statistical analysis.

Detailed Description

The need for endodontic treatment is still very common in the clinical routine, whether due to dento-alveolar trauma or caries. In some cases, the temporary filling procedure is required until the endodontic treatment is completed. The temporary filling material should be biocompatible and bacteriostatic. The aim of this study is through a randomized clinical trial, double blind, split-mouth, evaluate the success rate (contamination rate, periapical lesion relapse and the presence of exudate between the treatment's sessions) of endodontically treated teeth that required filling with temporary material. The composition of the temporary filling material (cement (Based on calcium hydroxide; and based on mineral trioxide aggregate) will be evaluated. Twenty participants with at least two teeth with the need of endodontic treatment will be selected. The teeth will be randomly divided into 2 different groups according to the temporary filling material composition (Based on calcium hydroxide; and based on mineral trioxide aggregate). Data will be collected, tabulated and submitted to statistical analysis.

Registry
clinicaltrials.gov
Start Date
May 1, 2018
End Date
December 30, 2019
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
PAULO VINICIUS SOARES
Responsible Party
Sponsor Investigator
Principal Investigator

PAULO VINICIUS SOARES

Director of NCCL Research Group

Federal University of Uberlandia

Eligibility Criteria

Inclusion Criteria

  • Healthy volunteers
  • Both genres
  • Presence of at least two teeth with indication of endodontic treatment
  • Good oral hygiene

Exclusion Criteria

  • Dentures or orthodontics
  • Presence of periodontal disease
  • Presence of parafunctional habits
  • Presence of systemic disease
  • Presence of severe psychological disturbe;
  • Constant use of analgesic and, or anti-inflammatory
  • Allergic response to dental products

Arms & Interventions

MTA temporary filling material

Temporary filling with MTA

Intervention: Definiteve canal root obturation

MTA temporary filling material

Temporary filling with MTA

Intervention: Definitve restoration

MTA temporary filling material

Temporary filling with MTA

Intervention: Material insertion on the root canal

MTA temporary filling material

Temporary filling with MTA

Intervention: Material re-insertion on the root canal accordging to the infection needs.

MTA temporary filling material

Temporary filling with MTA

Intervention: Absolute isolation

MTA temporary filling material

Temporary filling with MTA

Intervention: Manipulation of the temporary filling material based on Mineral trioxide aggregate

Calcium Hydroxide temporary filling material

Temporary filling with Ca(OH)2

Intervention: Carie removal

Calcium Hydroxide temporary filling material

Temporary filling with Ca(OH)2

Intervention: Absolute isolation

Calcium Hydroxide temporary filling material

Temporary filling with Ca(OH)2

Intervention: Manipulation of the temporary filling material based on Calcium Hydroxide

Calcium Hydroxide temporary filling material

Temporary filling with Ca(OH)2

Intervention: Material insertion on the root canal

Calcium Hydroxide temporary filling material

Temporary filling with Ca(OH)2

Intervention: Material re-insertion on the root canal accordging to the infection needs.

Calcium Hydroxide temporary filling material

Temporary filling with Ca(OH)2

Intervention: Definiteve canal root obturation

Calcium Hydroxide temporary filling material

Temporary filling with Ca(OH)2

Intervention: Definitve restoration

MTA temporary filling material

Temporary filling with MTA

Intervention: Carie removal

Outcomes

Primary Outcomes

Contamination rate of endodontically treated teeth that required filling with temporary material with a 1 year follow up.

Time Frame: 1 year

Periapical lesion relapse of endodontically treated teeth that required filling with temporary material with a 1 year follow up.

Time Frame: 1 year

Presence of exudate between the treatment's sessions of endodontically treated teeth that required filling with temporary material with a 1 year follow up.

Time Frame: 1 year

Study Sites (1)

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