Anti-inflammatory Steroids in the Prevention of Tooth Sensitivity

Sponsor
Universidade Federal Fluminense (Other)
Overall Status
Completed
CT.gov ID
NCT02956070
Collaborator
(none)
70
Enrollment
2
Arms
7
Duration (Months)

Study Details

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: Dexamethasone acetate
  • Drug: Potassium Nitrate
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Evaluation of Anti-inflammatory Steroids of Use in the Prevention of Tooth Sensitivity in Teeth Whitening Technique Office
Study Start Date :
Oct 1, 2015
Actual Primary Completion Date :
May 1, 2016
Actual Study Completion Date :
May 1, 2016

Arms and Interventions

ArmIntervention/Treatment
Experimental: Experimental

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

Drug: Dexamethasone acetate
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 .
Other Names:
  • Dexamethasone
  • Placebo Comparator: Placebo

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

    Drug: Potassium Nitrate
    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 .
    Other Names:
  • Smoothe SDI
  • Outcome Measures

    Primary Outcome Measures

    1. Visual Analogic Scale (0-100) for Tooth Sensibility. [One hour]

      The investigators evaluated the tooth sensibility 1 hour post-bleaching. Scale from 0-100 0 means no sensibility 100 means maximum sensibility

    2. Visual Analogic Scale(0-100) for Tooth Sensibility. [Twenty four hours]

      The investigators evaluated the tooth sensibility 24 hours post-bleaching. Scale from 0-100 0 means no sensibility 100 means maximum sensibility

    3. Visual Analogic Scale(0-100) for Tooth Sensibility. [Forty eight hours]

      The investigators evaluated the tooth sensibility 48 hours post-bleaching. Scale from 0-100 0 means no sensibility 100 means maximum sensibility

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Universidade Federal Fluminense

    Investigators

    • Principal Investigator: Marcos O Barceleiro, MSD, PhD, Fluminense Federal University

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Luiz Augusto da Costa Poubel, Professor, Universidade Federal Fluminense
    ClinicalTrials.gov Identifier:
    NCT02956070
    Other Study ID Numbers:
    • bleaching
    First Posted:
    Nov 4, 2016
    Last Update Posted:
    Nov 25, 2020
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Luiz Augusto da Costa Poubel, Professor, Universidade Federal Fluminense
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group TitleExperimentalPlacebo
    Arm/Group Description35 patients in this group underwent the whitening procedure using the Dexamethasone acetate intervention. Dexamethasone acetate: The volunteers in the Dexamethasone acetate group (experimental group) received 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 w35 patients in this group underwent the whitening procedure using the Potassium Nitrate intervention Potassium Nitrate: The volunteers in the Potassium Nitrate Group (Placebo group) received 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 .
    Period Title: Overall Study
    STARTED3535
    COMPLETED3535
    NOT COMPLETED00

    Baseline Characteristics

    Arm/Group TitleExperimentalPlaceboTotal
    Arm/Group Description35 patients in this group underwent the whitening procedure using the Dexamethasone acetate intervention. Dexamethasone acetate: The volunteers in this group received 6 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 9 am to 1 day before session whitening, 8 mg 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 was applied with a brush on the labial surface of the teeth whitened for 2 to 3 minutes .35 patients in this group underwent the whitening procedure using the Potassium Nitrate intervention Potassium Nitrate: The volunteers in the Potassium Nitrate Group (Placebo group) received 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 .Total of all reporting groups
    Overall Participants353570
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    22.3
    (2.7)
    22.5
    (2.1)
    22.4
    (2.4)
    Sex: Female, Male (Count of Participants)
    Female
    27
    77.1%
    23
    65.7%
    50
    71.4%
    Male
    8
    22.9%
    12
    34.3%
    20
    28.6%
    Race and Ethnicity Not Collected (Count of Participants)
    Count of Participants [Participants]
    0
    0%
    Region of Enrollment (participants) [Number]
    Brazil
    35
    100%
    35
    100%
    70
    100%

    Outcome Measures

    1. Primary Outcome
    TitleVisual Analogic Scale (0-100) for Tooth Sensibility.
    DescriptionThe investigators evaluated the tooth sensibility 1 hour post-bleaching. Scale from 0-100 0 means no sensibility 100 means maximum sensibility
    Time FrameOne hour

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleExperimentalPlacebo
    Arm/Group Description35 patients in this group underwent the whitening procedure using the Dexamethasone acetate intervention. Dexamethasone acetate: The volunteers in this group received 6 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 9 am to 1 day before session whitening, 8 mg 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 was applied with a brush on the labial surface of the teeth whitened for 2 to 3 minutes .35 patients in this group underwent the whitening procedure using the Potassium Nitrate intervention Potassium Nitrate: The volunteers in the Potassium Nitrate Group (Placebo group) received 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 .
    Measure Participants3535
    Mean (Standard Deviation) [units on a scale]
    6.31
    (12.78)
    11.14
    (20.08)
    2. Primary Outcome
    TitleVisual Analogic Scale(0-100) for Tooth Sensibility.
    DescriptionThe investigators evaluated the tooth sensibility 24 hours post-bleaching. Scale from 0-100 0 means no sensibility 100 means maximum sensibility
    Time FrameTwenty four hours

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleExperimentalPlacebo
    Arm/Group Description35 patients in this group underwent the whitening procedure using the Dexamethasone acetate intervention. Dexamethasone acetate: The volunteers in this group received 6 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 9 am to 1 day before session whitening, 8 mg 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 was applied with a brush on the labial surface of the teeth whitened for 2 to 3 minutes .35 patients in this group underwent the whitening procedure using the Potassium Nitrate intervention Potassium Nitrate: The volunteers in the Potassium Nitrate Group (Placebo group) received 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 .
    Measure Participants3535
    Mean (Standard Deviation) [units on a scale]
    5.06
    (9.86)
    8.26
    (13.48)
    3. Primary Outcome
    TitleVisual Analogic Scale(0-100) for Tooth Sensibility.
    DescriptionThe investigators evaluated the tooth sensibility 48 hours post-bleaching. Scale from 0-100 0 means no sensibility 100 means maximum sensibility
    Time FrameForty eight hours

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleExperimentalPlacebo
    Arm/Group Description35 patients in this group underwent the whitening procedure using the Dexamethasone acetate intervention. Dexamethasone acetate: The volunteers in this group received 6 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 9 am to 1 day before session whitening, 8 mg 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 was applied with a brush on the labial surface of the teeth whitened for 2 to 3 minutes .35 patients in this group underwent the whitening procedure using the Potassium Nitrate intervention Potassium Nitrate: The volunteers in the Potassium Nitrate Group (Placebo group) received 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 .
    Measure Participants3535
    Mean (Standard Deviation) [units on a scale]
    0.37
    (1.54)
    2.91
    (9.14)

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group TitleExperimentalPlacebo
    Arm/Group Description35 patients in this group underwent the whitening procedure using the Dexamethasone acetate intervention. Dexamethasone acetate: The volunteers in this group received 6 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 9 am to 1 day before session whitening, 8 mg 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 was applied with a brush on the labial surface of the teeth whitened for 2 to 3 minutes .35 patients in this group underwent the whitening procedure using the Potassium Nitrate intervention Potassium Nitrate: The volunteers in the Potassium Nitrate Group (Placebo group) received 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 .
    All Cause Mortality
    ExperimentalPlacebo
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/35 (0%) 0/35 (0%)
    Serious Adverse Events
    ExperimentalPlacebo
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/35 (0%) 0/35 (0%)
    Other (Not Including Serious) Adverse Events
    ExperimentalPlacebo
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/35 (0%) 0/35 (0%)

    Limitations/Caveats

    No discontinuity in both treatment groups was found in the clinical investigation. All volunteers attended the recall visit 1 week postbleaching.

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/TitleDr. Luiz Augusto Poubel
    OrganizationUniversidade Federal Fluminense
    Phone55 21 981113344
    Emailluizpoubel@id.uff.br
    Responsible Party:
    Luiz Augusto da Costa Poubel, Professor, Universidade Federal Fluminense
    ClinicalTrials.gov Identifier:
    NCT02956070
    Other Study ID Numbers:
    • bleaching
    First Posted:
    Nov 4, 2016
    Last Update Posted:
    Nov 25, 2020
    Last Verified:
    Nov 1, 2020