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Objectives:
The aim of this in vivo randomized clinical trial with split-mouth design was to evaluate the clinical efficacy of one in-office application of a fluoride containing varnish and in office application of a bonding resin in adult patients presenting with dentin hypersensitivity.
Materials and Methods:
The study cohort consisted of 38 Caucasian outpatients, giving a total of 180 teeth were treated by fluoride varnish (FV) and 160 - by bonding agent (BA). Baseline pain in FV group was slightly higher on both scales (SCHIFF and VAS). Outcome measurements were assessed one or two weeks before product application (enrollment), at baseline at the application days (end of the run-in period: T0a, T0b, T0c), and at 1 week and at 1-2-6 months after first treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Varnish fluoride | Experimental | Varnish fluoride to be applied on the surface of exposed dentin |
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| Bonding agent | Active Comparator | Bonding agent to be applied on the surface of exposed dentin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Application of varnish fluoride desensitizing agent on buccal surfaces of exposed dentin | Procedure | Varnish fluoride is a single dose transparent varnish with 5 % sodium fluoride (22.600 ppm fluoride) and 5 % calcium fluoride. The application was performed according to the manufacturer's instructions. The varnish was applied on a clean and dry surface, then after 10-20 seconds to allow the fluoride varnish to be absorbed, was then dried with air. |
| Measure | Description | Time Frame |
|---|---|---|
| Level of Pain assessment with the Schiff Sensitivity Scale | A score of 0, 1, 2 or 3 was given by the participant. 0 = No subject response to stimulus, 1 = Subject response but will continue, 2 = Subject responds and moves or requests discontinuation, 3 = Painful response to stimulus, discontinuation requested. The lower the score, the lower the hypersensitivity. Air-blast stimulus was used: the response to a jet of cold air was rated by the examiner. | All study participants were asked to record the pain intensity score at the baseline, before the application of the desensitizing agents |
| Level of Pain assessment with the Schiff Sensitivity Scale | A score of 0, 1, 2 or 3 was given by the participant. 0 = No subject response to stimulus, 1 = Subject response but will continue, 2 = Subject responds and moves or requests discontinuation, 3 = Painful response to stimulus, discontinuation requested. The lower the score, the lower the hypersensitivity. Air-blast stimulus was used: the response to a jet of cold air was rated by the examiner. | All study participants were asked to record the pain intensity score at seven days after the application of the desensitizing agents |
| Level of Pain assessment with the Schiff Sensitivity Scale | A score of 0, 1, 2 or 3 was given by the participant. 0 = No subject response to stimulus, 1 = Subject response but will continue, 2 = Subject responds and moves or requests discontinuation, 3 = Painful response to stimulus, discontinuation requested. The lower the score, the lower the hypersensitivity. Air-blast stimulus was used: the response to a jet of cold air was rated by the examiner. | All study participants were asked to record the pain intensity score at one month after the application of the desensitizing agents |
| Level of Pain assessment with the Schiff Sensitivity Scale | A score of 0, 1, 2 or 3 was given by the participant. 0 = No subject response to stimulus, 1 = Subject response but will continue, 2 = Subject responds and moves or requests discontinuation, 3 = Painful response to stimulus, discontinuation requested. The lower the score, the lower the hypersensitivity. Air-blast stimulus was used: the response to a jet of cold air was rated by the examiner. |
| Measure | Description | Time Frame |
|---|---|---|
| Level of Pain assessment with the Visual Analogue Scale (VAS) | The level of pain was evaluated on a visual scale from 0 ("no pain") to 10 ("maximum pain"). The lower the score, the lower the hypersensitivity. Air-blast stimulus was used: the response to a jet of cold air was rated by the examiner. | All study participants were asked to record the pain intensity score at the baseline, before the application of the desensitizing agents |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Livia Ottolenghi, DDS,PhD | University of Roma La Sapienza | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oral and Maxillo-Facial Sciences, Sapienza University of Rome | Rome | RM | 00161 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34066300 | Derived | Mazur M, Jedlinski M, Ndokaj A, Ardan R, Janiszewska-Olszowska J, Nardi GM, Ottolenghi L, Guerra F. Long-Term Effectiveness of Treating Dentin Hypersensitivity with Bifluorid 10 and Futurabond U: A Split-Mouth Randomized Double-Blind Clinical Trial. J Clin Med. 2021 May 12;10(10):2085. doi: 10.3390/jcm10102085. |
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A randomized, slit-mouth, double blind clinical trial
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| Application of bonding agent desensitizing agent on buccal surfaces of exposed dentin | Procedure | Bonding agent is a single dose dual curing universal adhesive and its application was performed according to the manufacturer's instruction for cases with hypersensitive tooth necks. The bonding was applied without etching, on a clean and dry surface. After 10 s any excess material was removed and then light cured for 30 s. |
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| All study participants were asked to record the pain intensity score at two months after the application of the desensitizing agents |
| Level of Pain assessment with the Schiff Sensitivity Scale | A score of 0, 1, 2 or 3 was given by the participant. 0 = No subject response to stimulus, 1 = Subject response but will continue, 2 = Subject responds and moves or requests discontinuation, 3 = Painful response to stimulus, discontinuation requested. The lower the score, the lower the hypersensitivity. Air-blast stimulus was used: the response to a jet of cold air was rated by the examiner. | All study participants were asked to record the pain intensity score at six months after the application of the desensitizing agents |
| Level of Pain assessment with the Visual Analogue Scale (VAS) | The level of pain was evaluated on a visual scale from 0 ("no pain") to 10 ("maximum pain"). The lower the score, the lower the hypersensitivity. Air-blast stimulus was used: the response to a jet of cold air was rated by the examiner. | All study participants were asked to record the pain intensity score at seven days after the application of the desensitizing agents |
| Level of Pain assessment with the Visual Analogue Scale (VAS) | The level of pain was evaluated on a visual scale from 0 ("no pain") to 10 ("maximum pain"). The lower the score, the lower the hypersensitivity. Air-blast stimulus was used: the response to a jet of cold air was rated by the examiner. | All study participants were asked to record the pain intensity score at one month after the application of the desensitizing agents |
| Level of Pain assessment with the Visual Analogue Scale (VAS) | The level of pain was evaluated on a visual scale from 0 ("no pain") to 10 ("maximum pain"). The lower the score, the lower the hypersensitivity. Air-blast stimulus was used: the response to a jet of cold air was rated by the examiner. | All study participants were asked to record the pain intensity score at two months after the application of the desensitizing agents |
| Level of Pain assessment with the Visual Analogue Scale (VAS) | The level of pain was evaluated on a visual scale from 0 ("no pain") to 10 ("maximum pain"). The lower the score, the lower the hypersensitivity. Air-blast stimulus was used: the response to a jet of cold air was rated by the examiner. | All study participants were asked to record the pain intensity score at six months after the application of the desensitizing agents |
| ID | Term |
|---|---|
| D003807 | Dentin Sensitivity |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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