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Effectiveness of a Bonding and a Fluoride Varnish for Long-term Dentin Hypersensitivity Treatment.

Not Applicable
Completed
Conditions
To Decrease Dentin Hypersensitivity
Interventions
Procedure: Application of varnish fluoride desensitizing agent on buccal surfaces of exposed dentin
Procedure: Application of bonding agent desensitizing agent on buccal surfaces of exposed dentin
Registration Number
NCT04813848
Lead Sponsor
University of Roma La Sapienza
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
38
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Varnish fluorideApplication of varnish fluoride desensitizing agent on buccal surfaces of exposed dentinVarnish fluoride to be applied on the surface of exposed dentin
Bonding agentApplication of bonding agent desensitizing agent on buccal surfaces of exposed dentinBonding agent to be applied on the surface of exposed dentin
Primary Outcome Measures
NameTimeMethod
Level of Pain assessment with the Schiff Sensitivity ScaleAll study participants were asked to record the pain intensity score at six months after the application of the desensitizing agents

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.

Secondary Outcome Measures
NameTimeMethod
Level of Pain assessment with the Visual Analogue Scale (VAS)All study participants were asked to record the pain intensity score at six months after the application of the desensitizing agents

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.

Trial Locations

Locations (1)

Department of Oral and Maxillo-Facial Sciences, Sapienza University of Rome

🇮🇹

Rome, RM, Italy

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