Inflammation
Conditions
Keywords
dental bleaching, antiinflammatory, tooth sensitivity
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.
Interventions
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 .
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 .
Sponsors
Universidade Federal Fluminense
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental 35 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 |
| Placebo 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 . | 35 |
| Total | 70 |
Baseline characteristics
| Characteristic | Placebo | Total | Experimental |
|---|---|---|---|
| Age, Continuous | 22.5 years STANDARD_DEVIATION 2.1 | 22.4 years STANDARD_DEVIATION 2.4 | 22.3 years STANDARD_DEVIATION 2.7 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Brazil | 35 participants | 70 participants | 35 participants |
| Sex: Female, Male Female | 23 Participants | 50 Participants | 27 Participants |
| Sex: Female, Male Male | 12 Participants | 20 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 35 |
| other Total, other adverse events | 0 / 35 | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 | 0 / 35 |
Outcome results
Primary
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
Time frame: One hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental | Visual Analogic Scale (0-100) for Tooth Sensibility. | 6.31 units on a scale | Standard Deviation 12.78 |
| Placebo | Visual Analogic Scale (0-100) for Tooth Sensibility. | 11.14 units on a scale | Standard Deviation 20.08 |
Primary
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
Time frame: Twenty four hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental | Visual Analogic Scale(0-100) for Tooth Sensibility. | 5.06 units on a scale | Standard Deviation 9.86 |
| Placebo | Visual Analogic Scale(0-100) for Tooth Sensibility. | 8.26 units on a scale | Standard Deviation 13.48 |
Primary
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
Time frame: Forty eight hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental | Visual Analogic Scale(0-100) for Tooth Sensibility. | 0.37 units on a scale | Standard Deviation 1.54 |
| Placebo | Visual Analogic Scale(0-100) for Tooth Sensibility. | 2.91 units on a scale | Standard Deviation 9.14 |