Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 23 for:    Eugenol

Influence of the Composition of Temporary Restorative Material in Vital Teeth

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03437655
Recruitment Status : Not yet recruiting
First Posted : February 19, 2018
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
PAULO VINICIUS SOARES, Federal University of Uberlandia

Brief Summary:
The aim of this study is through a randomized clinical trial, double blind, splithmouth, evaluate the success rate (retation rate and dental sensibility) of temporary direct restorations in vital teeth. The composition of the temporary direct restoration (based on Zinc-Oxide with Eugenol; and mineral trioxide aggregate). Data will be collected, tabulated and submitted to statistical analysis.

Condition or disease Intervention/treatment Phase
MTA Dental Restoration, Temporary Procedure: Carie removal Procedure: Relative isolation Procedure: Manipulation of the temporary material based on Zinc Oxide and Eugenol Procedure: Manipulation of the temporary material based on Mineral trioxide aggregate Procedure: Material insertion on the cavity Procedure: Finishing the temporary direct restoration Not Applicable

Detailed Description:
The confection of temporary direct restoration is still verry commom in dental clinic routine, either by the time required or by biological requirements.The temporary restorations must have sufficient retention and solubility between the consultation intervals to avoid displacement and infiltration; besides being biocompatible to avoid sensitivity. The aim of this study is through a randomized clinical trial, double blind, splithmouth, evaluate the success rate (retention rate and dental sensibility) of temporary direct restoration on vital teeth. The composition of the temporary material (based on Zinc-Oxide with Eugenol; and based on mineral trioxide aggregate) will be evaluated. Twenty-five participants with at least two vital teeth with the need to confection of direct restoration (each participant) will be selected. The teeth will be randomly divided into 2 different groups according to the temporary material composition (Based on Zinc-Oxide with Eugenol; and based on mineral trioxide aggregate). Data will be collected, tabulated and submitted to statistical analysis.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Influence of the Composition of Temporary Restorative Material on the Retention Rate and Sensitivity for Provisional Direct Restorations in Vital Teeth - Clinical Study Randomized
Estimated Study Start Date : March 20, 2018
Estimated Primary Completion Date : April 30, 2018
Estimated Study Completion Date : October 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals

Arm Intervention/treatment
Active Comparator: Zinc oxide and eugenol
Temporary direct restoration with zinc oxide and eugenol.
Procedure: Carie removal
Carie removal with a low speed handpiece

Procedure: Relative isolation
Relative isolation with cotton and gauze.

Procedure: Manipulation of the temporary material based on Zinc Oxide and Eugenol
Manipulation of the temporary material based on Zinc Oxide and Eugenol according to the manufacturer's recommendations

Procedure: Material insertion on the cavity
Material insertion on the cavity according to the manufacturer's recommendations

Procedure: Finishing the temporary direct restoration
Excess cement removal; Occlusal Adjustment; Finishing and polishing.

Active Comparator: Mineral trioxide aggregate
Temporary direct restoration with Mineral trioxide aggregate.
Procedure: Carie removal
Carie removal with a low speed handpiece

Procedure: Relative isolation
Relative isolation with cotton and gauze.

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

Procedure: Material insertion on the cavity
Material insertion on the cavity according to the manufacturer's recommendations

Procedure: Finishing the temporary direct restoration
Excess cement removal; Occlusal Adjustment; Finishing and polishing.




Primary Outcome Measures :
  1. Success rate (retention rate and absence of sensibility) of temporary direct restoration with diferents temporary materials with a 15 days of follow up [ Time Frame: 15 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy volunteers; both genres; presence of at least two teeth with indication of direct restoration; good oral hygiene.

Exclusion Criteria:

  • Dentures or orthodontics; presence of periodontal disease and,or parafunctional habits; systemic disease and, or severe psychological; constant use of analgesic and, or anti-inflammatory or allergic response to dental products.

Information from the National Library of Medicine

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): NCT03437655


Locations
Layout table for location information
Brazil
Federal University of Uberlandia
Uberlandia, Minas Gerais, Brazil, 381440617
Sponsors and Collaborators
Federal University of Uberlandia

Publications:

Layout table for additonal information
Responsible Party: PAULO VINICIUS SOARES, Professor, Federal University of Uberlandia
ClinicalTrials.gov Identifier: NCT03437655     History of Changes
Other Study ID Numbers: 2.358.776
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Eugenol
Zinc
Zinc Oxide
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Dermatologic Agents
Sunscreening Agents
Radiation-Protective Agents
Protective Agents
Anti-Infective Agents