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Clinical Trials/NCT04813848
NCT04813848
Completed
Not Applicable

Effectiveness of a Bonding and a Fluoride Varnish for Long-term Dentin Hypersensitivity Treatment: a Split-mouth Randomized Clinical Trial

University of Roma La Sapienza1 site in 1 country38 target enrollmentJanuary 7, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
To Decrease Dentin Hypersensitivity
Sponsor
University of Roma La Sapienza
Enrollment
38
Locations
1
Primary Endpoint
Level of Pain assessment with the Schiff Sensitivity Scale
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 7, 2020
End Date
February 1, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Roma La Sapienza
Responsible Party
Principal Investigator
Principal Investigator

Livia Ottolenghi

DDS, PhD, Full Professor, Deputy Dean of the Faculty of Medicine and Dentistry, Dean of the Dental School

University of Roma La Sapienza

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.

Outcomes

Primary Outcomes

Level of Pain assessment with the Schiff Sensitivity Scale

Time Frame: All 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 Outcomes

  • 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)

Study Sites (1)

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