Clinical trial NCT04813848: Effectiveness of a Bonding and a Fluoride Varnish for Long-term Dentin Hypersensitivity Treatment.
Official title: Effectiveness of a Bonding and a Fluoride Varnish for Long-term Dentin Hypersensitivity Treatment: a Split-mouth Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: To Decrease Dentin Hypersensitivity
Keywords: dentin hypersensitivity
bonding agent
fluoride varnish
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2021-03-24
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, slit-mouth, double blind clinical trial
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* absence of systemic pathologies (ASA class I);
* not pregnant or lactating;
* good oral hygiene;
* with ≥1 sensitive tooth with exposed dentin on upper or lower dental arches;
* contemporary presence of exposed dentin both on the left and right counterpart of upper or lower arch.

Exclusion Criteria:

* domestic or in-office professional fluoride application and bleaching 6 months before beginning of treatment;
* long-term use of anti-inflammatory, analgesic and psychotropic drugs;
* eating disorders, systemic conditions that cause or predispose patients to develop dentin hypersensitivity (for example, Gastroesophageal reflux disease);
* periodontal surgery and within the previous three months before the study;
* orthodontic treatment within the previous three months before the study.

Primary outcomes:
measure: Level of Pain assessment with the Schiff Sensitivity Scale
timeFrame: All study participants were asked to record the pain intensity score at the baseline, before the application of the desensitizing agents
measure: Level of Pain assessment with the Schiff Sensitivity Scale
timeFrame: All study participants were asked to record the pain intensity score at seven days after the application of the desensitizing agents
measure: Level of Pain assessment with the Schiff Sensitivity Scale
timeFrame: All study participants were asked to record the pain intensity score at one month after the application of the desensitizing agents
measure: Level of Pain assessment with the Schiff Sensitivity Scale
timeFrame: All study participants were asked to record the pain intensity score at two months after the application of the desensitizing agents
measure: Level of Pain assessment with the Schiff Sensitivity Scale
timeFrame: All study participants were asked to record the pain intensity score at six months after the application of the desensitizing agents
Secondary outcomes:
measure: Level of Pain assessment with the Visual Analogue Scale (VAS)
timeFrame: All study participants were asked to record the pain intensity score at the baseline, before the application of the desensitizing agents
measure: Level of Pain assessment with the Visual Analogue Scale (VAS)
timeFrame: All study participants were asked to record the pain intensity score at seven days after the application of the desensitizing agents
measure: Level of Pain assessment with the Visual Analogue Scale (VAS)
timeFrame: All study participants were asked to record the pain intensity score at one month after the application of the desensitizing agents
measure: Level of Pain assessment with the Visual Analogue Scale (VAS)
timeFrame: All study participants were asked to record the pain intensity score at two months after the application of the desensitizing agents
measure: Level of Pain assessment with the Visual Analogue Scale (VAS)
timeFrame: All study participants were asked to record the pain intensity score at six months after the application of the desensitizing agents
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Department of Oral and Maxillo-Facial Sciences, Sapienza University of Rome
state: RM
Study officials:
affiliation: University of Roma La Sapienza
name: Livia Ottolenghi, DDS,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.