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Anti-inflammatory Steroids in the Prevention of Tooth Sensitivity

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ClinicalTrials.gov Identifier: NCT02956070
Recruitment Status : Completed
First Posted : November 4, 2016
Last Update Posted : November 4, 2016
Sponsor:
Information provided by (Responsible Party):
Luiz Augusto da Costa Poubel, Universidade Federal Fluminense

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 disease Intervention/treatment Phase
Inflammation Drug: Dexamethasone acetate Drug: Potassium Nitrate Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : October 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Potassium

Arm Intervention/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 Name: 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 Name: Smoothe SDI




Primary Outcome Measures :
  1. Visual analogic scale(0-10) for tooth sensibility. [ Time Frame: One hour ]
    The investigators will evaluate the tooth sensibility 1 hour post-bleaching.

  2. Visual analogic scale(0-10) for tooth sensibility. [ Time Frame: Twenty four hours ]
    The investigators will evaluate the tooth sensibility 24 hours post-bleaching.

  3. Visual analogic scale(0-10) for tooth sensibility. [ Time Frame: Forty eight hours ]
    The investigators will evaluate the tooth sensibility 48 hours post-bleaching.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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): NCT02956070


Sponsors and Collaborators
Universidade Federal Fluminense
Investigators
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Principal Investigator: Marcos O Barceleiro, MSD, PhD Fluminense Federal University

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Luiz Augusto da Costa Poubel, Professor, Universidade Federal Fluminense
ClinicalTrials.gov Identifier: NCT02956070     History of Changes
Other Study ID Numbers: bleaching
First Posted: November 4, 2016    Key Record Dates
Last Update Posted: November 4, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Luiz Augusto da Costa Poubel, Universidade Federal Fluminense:
dental bleaching
antiinflammatory
tooth sensitivity
Additional relevant MeSH terms:
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Dentin Sensitivity
Hypersensitivity
Inflammation
Pathologic Processes
Immune System Diseases
Tooth Diseases
Stomatognathic Diseases
Dexamethasone
Dexamethasone acetate
Anti-Inflammatory Agents
BB 1101
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action