Skip to main content
OpenTrials
Completed

NCT Number: NCT04813848

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

To Decrease Dentin Hypersensitivity Dentin Sensitivity Stomatognathic Diseases Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Rome, RM, 00161, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Bifluorid, Voco GmbH

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.

Other names: Futurabond U, Voco GmbH

Primary outcomes

  1. Level of Pain assessment with the Schiff Sensitivity Scale

    Time frame: All study participants were asked to record the pain intensity score at the baseline, before 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.

  2. Level of Pain assessment with the Schiff Sensitivity Scale

    Time frame: All study participants were asked to record the pain intensity score at seven days 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.

  3. Level of Pain assessment with the Schiff Sensitivity Scale

    Time frame: All study participants were asked to record the pain intensity score at one month 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.

  4. Level of Pain assessment with the Schiff Sensitivity Scale

    Time frame: All study participants were asked to record the pain intensity score at two 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.

  5. 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

  1. Level of Pain assessment with the Visual Analogue Scale (VAS)

    Time frame: All study participants were asked to record the pain intensity score at the baseline, before 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.

  2. Level of Pain assessment with the Visual Analogue Scale (VAS)

    Time frame: All study participants were asked to record the pain intensity score at seven days 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.

  3. Level of Pain assessment with the Visual Analogue Scale (VAS)

    Time frame: All study participants were asked to record the pain intensity score at one month 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.

  4. Level of Pain assessment with the Visual Analogue Scale (VAS)

    Time frame: All study participants were asked to record the pain intensity score at two 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.

  5. Level of Pain assessment with the Visual Analogue Scale (VAS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Mar 24, 2021
Registry last updated
Mar 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.