N/A
N=70
Anti-inflammatory Steroids in the Prevention of Tooth Sensitivity
Inflammation
Bottom Line
View on ClinicalTrials.gov: NCT02956070 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Visual Analogic Scale (0-100) for Tooth Sensibility. — 6.31; 11.14 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Dexamethasone acetate (Drug); Potassium Nitrate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Universidade Federal Fluminense
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Analogic Scale (0-100) for Tooth Sensibility. |
6.31; 11.14 | — |
| PRIMARY Visual Analogic Scale(0-100) for Tooth Sensibility. |
0.37; 2.91 | — |
| PRIMARY Visual Analogic Scale(0-100) for Tooth Sensibility. |
0.37; 2.91 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02956070). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.