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
About this trial
This is an interventional prevention trial for Inflammation focused on measuring dental bleaching, antiinflammatory, tooth sensitivity
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.
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
NCT ID
NCT02956070
First Posted
October 25, 2016
Last Updated
November 3, 2020
Sponsor
Universidade Federal Fluminense
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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