Clinical trial NCT03488316: Influence of Temporary Filling Material Composition on the Success Rate of Endodontic Treatments
Official title: Influence of Temporary Filling Material Composition on the Success Rate of Endodontic Treatments - Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: MTA
Calcium Hydroxide
Endodontic Treatment
Lead sponsor: Federal University of Uberlandia
Sponsor class: OTHER
First posted: 2018-04-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.

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

Primary outcomes:
measure: Contamination rate of endodontically treated teeth that required filling with temporary material with a 1 year follow up.
timeFrame: 1 year
measure: Periapical lesion relapse of endodontically treated teeth that required filling with temporary material with a 1 year follow up.
timeFrame: 1 year
measure: Presence of exudate between the treatment's sessions of endodontically treated teeth that required filling with temporary material with a 1 year follow up.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Uberlandia
country: Brazil
facility: Federal University of Uberlandia
state: Minas Gerais
Study officials:
References:
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