Influence of Temporary Filling Material Composition on the Success Rate of Endodontic Treatments

Not Applicable

• Conditions: Endodontic Treatment; MTA; Calcium Hydroxide
• Interventions: Procedure: Carie removal; Procedure: Absolute isolation; Drug: Manipulation of the temporary filling material based on Calcium Hydroxide; Drug: Manipulation of the temporary filling material based on Mineral trioxide aggregate; Procedure: Material insertion on the root canal; Procedure: Material re-insertion on the root canal accordging to the infection needs.; Procedure: Definiteve canal root obturation; Procedure: Definitve restoration

• Registration Number: NCT03488316
• Lead Sponsor: PAULO VINICIUS SOARES

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.

Study Timeline

• Study First Submitted: 2018-03-06
• Study First Submitted QC: 2018-03-28
• Status Verified: 2018-04
• Study First Posted: 2018-04-05
• Last Update Submitted: 2018-04-06
• Last Update Posted: 2018-04-10
• Study Start: 2018-05-01
• Primary Completion: 2018-07-01
• Study Completion: 2019-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Calcium Hydroxide temporary filling material	Carie removal	Temporary filling with Ca(OH)2
Calcium Hydroxide temporary filling material	Absolute isolation	Temporary filling with Ca(OH)2
Calcium Hydroxide temporary filling material	Manipulation of the temporary filling material based on Calcium Hydroxide	Temporary filling with Ca(OH)2
Calcium Hydroxide temporary filling material	Material insertion on the root canal	Temporary filling with Ca(OH)2
Calcium Hydroxide temporary filling material	Material re-insertion on the root canal accordging to the infection needs.	Temporary filling with Ca(OH)2
Calcium Hydroxide temporary filling material	Definiteve canal root obturation	Temporary filling with Ca(OH)2
Calcium Hydroxide temporary filling material	Definitve restoration	Temporary filling with Ca(OH)2
MTA temporary filling material	Carie removal	Temporary filling with MTA
MTA temporary filling material	Absolute isolation	Temporary filling with MTA
MTA temporary filling material	Manipulation of the temporary filling material based on Mineral trioxide aggregate	Temporary filling with MTA
MTA temporary filling material	Material insertion on the root canal	Temporary filling with MTA
MTA temporary filling material	Material re-insertion on the root canal accordging to the infection needs.	Temporary filling with MTA
MTA temporary filling material	Definiteve canal root obturation	Temporary filling with MTA
MTA temporary filling material	Definitve restoration	Temporary filling with MTA

Primary Outcome Measures

Name	Time	Method
Contamination rate of endodontically treated teeth that required filling with temporary material with a 1 year follow up.	1 year
Periapical lesion relapse of endodontically treated teeth that required filling with temporary material with a 1 year follow up.	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.	1 year

Trial Locations

Locations (1)

Federal University of Uberlandia; 🇧🇷 Uberlandia, Minas Gerais, Brazil