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

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

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.

Study Overview

• Status: Completed
• Conditions: To Decrease Dentin Hypersensitivity
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • RM
    • Rome, RM, Italy, 00161
      • Department of Oral and Maxillo-Facial Sciences, Sapienza University of Rome

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Varnish fluoride; Varnish fluoride to be applied on the surface of exposed dentin	Procedure: Application of varnish fluoride desensitizing agent on buccal surfaces of exposed dentin; 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
Active Comparator: Bonding agent; Bonding agent to be applied on the surface of exposed dentin	Procedure: Application of bonding agent desensitizing agent on buccal surfaces of exposed dentin; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza
• Investigators: Principal Investigator: Livia Ottolenghi, DDS,PhD, University of Roma La Sapienza

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2020
• Primary Completion (Actual): September 10, 2020
• Study Completion (Actual): February 1, 2021

Study Registration Dates

• First Submitted: March 21, 2021
• First Submitted That Met QC Criteria: March 21, 2021
• First Posted (Actual): March 24, 2021

Study Record Updates

• Last Update Posted (Actual): March 24, 2021
• Last Update Submitted That Met QC Criteria: March 21, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: fluoride varnish; dentin hypersensitivity; bonding agent
• Additional Relevant MeSH Terms: Immune System Diseases; Stomatognathic Diseases; Tooth Diseases; Hypersensitivity; Dentin Sensitivity; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides
• Other Study ID Numbers: 5877/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No