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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03488316
Enrollment
20
Registered
2018-04-05
Start date
2018-05-01
Completion date
2019-12-30
Last updated
2018-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MTA, Calcium Hydroxide, Endodontic Treatment

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.

Interventions

PROCEDURECarie removal

Carie removal with a low speed handpiece

Absolute isolation with rubber dam

DRUGManipulation of the temporary filling material based on Calcium Hydroxide

Manipulation of the temporary material based on Calcium Hydroxide according to the manufacturer's recommendations.

DRUGManipulation of the temporary filling material based on Mineral trioxide aggregate

Manipulation of the temporary material based on Mineral trioxide aggregate according to the manufacturer's recommendations.

PROCEDUREMaterial insertion on the root canal

Material insertion on the root canal according to the manufacturer's recommendations

PROCEDUREMaterial re-insertion on the root canal accordging to the infection needs.

Material re-insertion on the root canal according to the manufacturer's recommendations

PROCEDUREDefiniteve canal root obturation

Definiteve canal root obturation with gutta-percha and definitive cement.

PROCEDUREDefinitve restoration

Definitve restoration confecction.

Sponsors

PAULO VINICIUS SOARES
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026