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Anti-inflammatory Steroids in the Prevention of Tooth Sensitivity

Primary Purpose

Inflammation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dexamethasone acetate
Potassium Nitrate
Sponsored by
Universidade Federal Fluminense
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Inflammation focused on measuring dental bleaching, antiinflammatory, tooth sensitivity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • The selected volunteers should present a good general state of health, be at least 18 years of age, regardless of gender, color / race and ethnicity, sexual orientation, and gender identity.
  • Volunteers must have an acceptable oral hygiene, present the upper and lower arches without absence of teeth of first premolar right to the left first premolar.
  • These elements have to be healthy, that is, not having any kind of restoration.
  • Volunteers must sign the consent form and clarification, have committed to return for periodic examinations and belong to the group of nonsmokers.

Exclusion Criteria:

  • Do not have medical history of diseases that can affect the results of the study;
  • subjects could not have made use of cigarettes in the last 30 days; have some important pathology in the oral cavity;
  • not being pregnant and also are not breastfeeding;
  • having any history of sensitivity or adverse reactions to anti-inflammatory used in the study;
  • not having calculations or advanced periodontal disease;
  • have not consumed drugs, alcohol or any medication that can cover the results, as other types of anti-inflammatories or painkillers;
  • The volunteers should not have used products indicated for dental sensitivity, as desensitizing toothpaste or similar product and not present recession or exacerbated hypersensitivity history.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Experimental

    Placebo

    Arm Description

    35 patients in this group will undergo the whitening procedure using the Dexamethasone acetate intervention.

    35 patients in this group will undergo the whitening procedure using the Potassium Nitrate intervention

    Outcomes

    Primary Outcome Measures

    Visual Analogic Scale (0-100) for Tooth Sensibility.
    The investigators evaluated the tooth sensibility 1 hour post-bleaching. Scale from 0-100 0 means no sensibility 100 means maximum sensibility
    Visual Analogic Scale(0-100) for Tooth Sensibility.
    The investigators evaluated the tooth sensibility 24 hours post-bleaching. Scale from 0-100 0 means no sensibility 100 means maximum sensibility
    Visual Analogic Scale(0-100) for Tooth Sensibility.
    The investigators evaluated the tooth sensibility 48 hours post-bleaching. Scale from 0-100 0 means no sensibility 100 means maximum sensibility

    Secondary Outcome Measures

    Full Information

    First Posted
    October 25, 2016
    Last Updated
    November 3, 2020
    Sponsor
    Universidade Federal Fluminense
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02956070
    Brief Title
    Anti-inflammatory Steroids in the Prevention of Tooth Sensitivity
    Official Title
    Evaluation of Anti-inflammatory Steroids of Use in the Prevention of Tooth Sensitivity in Teeth Whitening Technique Office
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2015 (undefined)
    Primary Completion Date
    May 2016 (Actual)
    Study Completion Date
    May 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidade Federal Fluminense

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Clinical randomized, triple-blind, used to measure the level of tooth sensitivity on volunteers using a modified virtual analog scale (VAS). Sixty-six volunteers will be selected and recruited, following inclusion criteria and pre-established exclusion. All volunteers will be guided and sign a term of clarification and consent. Volunteers will be randomly divided into two groups: the control group to receive placebo capsules and application of desensitizing gel containing 6% potassium nitrate and 0.10% fluoro- (conventional treatment) and the experimental group will receive the anti-inflammatory corticosteroids (dexamethasone, capsule - 8mg) and application of a placebo gel. Patients will be treated in two clinical sessions with an interval of 7 days (one week) between them. The protocol for use of the product is as follows: The volunteers in the experimental group will receive six capsules of dexamethasone 8 mg each to be administered orally, initially two days before the first bleaching query as follows: 8 mg (1 capsule) 9 am in the morning two days before the first clinical session whitening; 8 mg (1 capsule) the 9 am to 1 day before the first practice session whitening, 8 mg (1 capsule) to 9 am on the day of the first practice session of whitening. After 7 days (one week), the same protocol will be held for the second and final practice session office bleaching.
    Detailed Description
    The experimental design will follow the consolidated standards for test reports (CONSORT). After approval by the Ethics Committee for Research duly registered, the trial will be conducted in the clinic of dental school at the Federal Fluminense University located in Nova Friburgo.Every Health Institute participants will be informed about the nature and objectives of the study.It will be one test study Clinical randomized, parallel, triple-blind, used to measure the level of tooth sensitivity volunteers using a modified virtual analog scale (VAS). Sixty-six volunteers will be selected and recruited, following inclusion criteria and pre-established exclusion. All volunteers will be guided and sign a term of clarification and consent. Volunteers will be randomly divided into two groups: the control group to receive placebo capsules and application of desensitizing gel containing 6% potassium nitrate and 0.10% fluoro- (conventional treatment) and the experimental group will receive the anti-inflammatory corticosteroids (dexamethasone, capsule - 8mg) and application of a placebo gel. Patients will be treated in two clinical sessions with an interval of 7 days (one week) between them. The protocol for use of the product is as follows: The volunteers in the experimental group will receive six capsules of dexamethasone 8 mg each to be administered orally, initially two days before the first bleaching query as follows: 8 mg (1 capsule) 9 am in the morning two days before the first clinical session whitening; 8 mg (1 capsule) the 9 am to 1 day before the first practice session whitening, 8 mg (1 capsule) to 9 am on the day of the first practice session of whitening. After 7 days (one week), the same protocol will be held for the second and final practice session office bleaching.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Inflammation
    Keywords
    dental bleaching, antiinflammatory, tooth sensitivity

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    70 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental
    Arm Type
    Experimental
    Arm Description
    35 patients in this group will undergo the whitening procedure using the Dexamethasone acetate intervention.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    35 patients in this group will undergo the whitening procedure using the Potassium Nitrate intervention
    Intervention Type
    Drug
    Intervention Name(s)
    Dexamethasone acetate
    Other Intervention Name(s)
    Dexamethasone
    Intervention Description
    The volunteers in the Dexamethasone acetate group (experimental group) will receive six capsules of dexamethasone 8 mg each to be administered orally, initially two days before the first bleaching query as follows: 8 mg (1 capsule) 9 am two days before the first clinical session whitening; 8 mg (1 capsule) the 9 am to 1 day before session whitening, 8 mg (1 capsule) to 9 am on the day of the first session of whitening.Clinical intervention: 1- Dry teeth and apply Gingival Barrier to both arches. 2- Light cure. 3- Firmly attach a mixing nozzle to the Pola Office+. 4- Apply a thin layer of gel to all teeth undergoing treatment. 5- Leave gel on for 8 minutes. 6- Suction it off. 7- Repeat steps 5-6 twice times. 8- After the last application, suction all the gel off, then wash and apply suction. 9- Remove Gingival Barrier. 10- A placebo gel will be applied with a brush on the labial surface of the teeth whitened for 2 to 3 minutes .
    Intervention Type
    Drug
    Intervention Name(s)
    Potassium Nitrate
    Other Intervention Name(s)
    Smoothe SDI
    Intervention Description
    The volunteers in the Potassium Nitrate Group (Placebo group) will receive 6 placebo capsules, who contained the same components of de dexamethasone drug except the active ingredient (starch [50%], lactose monohydrate [35%], dibasic calcium phosphate [14%], and magnesium stearate [1%]).Clinical session:1- Dry teeth and apply Gingival Barrier to both arches. 2- Light cure. 3- Firmly attach a mixing nozzle to the Pola Office+. 4- Apply a thin layer of gel to all teeth undergoing treatment. 5- Leave gel on for 8 minutes. 6- Suction it off. 7- Repeat steps 5-6 twice times. 8- After the last application, suction all the gel off, then wash and apply suction. 9- Remove Gingival Barrier. 10- A desensitizing gel containing 6% potassium nitrate will be applied with a brush on the labial surface of the teeth whitened for 2 to 3 minutes .
    Primary Outcome Measure Information:
    Title
    Visual Analogic Scale (0-100) for Tooth Sensibility.
    Description
    The investigators evaluated the tooth sensibility 1 hour post-bleaching. Scale from 0-100 0 means no sensibility 100 means maximum sensibility
    Time Frame
    One hour
    Title
    Visual Analogic Scale(0-100) for Tooth Sensibility.
    Description
    The investigators evaluated the tooth sensibility 24 hours post-bleaching. Scale from 0-100 0 means no sensibility 100 means maximum sensibility
    Time Frame
    Twenty four hours
    Title
    Visual Analogic Scale(0-100) for Tooth Sensibility.
    Description
    The investigators evaluated the tooth sensibility 48 hours post-bleaching. Scale from 0-100 0 means no sensibility 100 means maximum sensibility
    Time Frame
    Forty eight hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: The selected volunteers should present a good general state of health, be at least 18 years of age, regardless of gender, color / race and ethnicity, sexual orientation, and gender identity. Volunteers must have an acceptable oral hygiene, present the upper and lower arches without absence of teeth of first premolar right to the left first premolar. These elements have to be healthy, that is, not having any kind of restoration. Volunteers must sign the consent form and clarification, have committed to return for periodic examinations and belong to the group of nonsmokers. Exclusion Criteria: Do not have medical history of diseases that can affect the results of the study; subjects could not have made use of cigarettes in the last 30 days; have some important pathology in the oral cavity; not being pregnant and also are not breastfeeding; having any history of sensitivity or adverse reactions to anti-inflammatory used in the study; not having calculations or advanced periodontal disease; have not consumed drugs, alcohol or any medication that can cover the results, as other types of anti-inflammatories or painkillers; The volunteers should not have used products indicated for dental sensitivity, as desensitizing toothpaste or similar product and not present recession or exacerbated hypersensitivity history.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marcos O Barceleiro, MSD, PhD
    Organizational Affiliation
    Fluminense Federal University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    Anti-inflammatory Steroids in the Prevention of Tooth Sensitivity

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