Back to resultsEffectiveness of a Bonding and a Fluoride Varnish for Long-term Dentin Hypersensitivity Treatment.
Primary Purpose
To Decrease Dentin Hypersensitivity
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Application of varnish fluoride desensitizing agent on buccal surfaces of exposed dentin
Application of bonding agent desensitizing agent on buccal surfaces of exposed dentin
Sponsored by
About this trial
This is an interventional treatment trial for To Decrease Dentin Hypersensitivity focused on measuring dentin hypersensitivity, bonding agent, fluoride varnish
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.
Sites / Locations
- Department of Oral and Maxillo-Facial Sciences, Sapienza University of Rome
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Varnish fluoride
Bonding agent
Arm Description
Varnish fluoride to be applied on the surface of exposed dentin
Bonding agent to be applied on the surface of exposed dentin
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT04813848
First Posted
March 21, 2021
Last Updated
March 21, 2021
Sponsor
University of Roma La Sapienza
1. Study Identification
Unique Protocol Identification Number
NCT04813848
Brief Title
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
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 7, 2020 (Actual)
Primary Completion Date
September 10, 2020 (Actual)
Study Completion Date
February 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
To Decrease Dentin Hypersensitivity
Keywords
dentin hypersensitivity, bonding agent, fluoride varnish
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized, slit-mouth, double blind clinical trial
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Varnish fluoride
Arm Type
Experimental
Arm Description
Varnish fluoride to be applied on the surface of exposed dentin
Arm Title
Bonding agent
Arm Type
Active Comparator
Arm Description
Bonding agent to be applied on the surface of exposed dentin
Intervention Type
Procedure
Intervention Name(s)
Application of varnish fluoride desensitizing agent on buccal surfaces of exposed dentin
Other Intervention Name(s)
Bifluorid, Voco GmbH
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Application of bonding agent desensitizing agent on buccal surfaces of exposed dentin
Other Intervention Name(s)
Futurabond U, Voco GmbH
Intervention Description
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.
Primary Outcome Measure Information:
Title
Level of Pain assessment with the Schiff Sensitivity Scale
Description
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.
Time Frame
All study participants were asked to record the pain intensity score at the baseline, before the application of the desensitizing agents
Title
Level of Pain assessment with the Schiff Sensitivity Scale
Description
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.
Time Frame
All study participants were asked to record the pain intensity score at seven days after the application of the desensitizing agents
Title
Level of Pain assessment with the Schiff Sensitivity Scale
Description
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.
Time Frame
All study participants were asked to record the pain intensity score at one month after the application of the desensitizing agents
Title
Level of Pain assessment with the Schiff Sensitivity Scale
Description
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.
Time Frame
All study participants were asked to record the pain intensity score at two months after the application of the desensitizing agents
Title
Level of Pain assessment with the Schiff Sensitivity Scale
Description
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.
Time Frame
All study participants were asked to record the pain intensity score at six months after the application of the desensitizing agents
Secondary Outcome Measure Information:
Title
Level of Pain assessment with the Visual Analogue Scale (VAS)
Description
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.
Time Frame
All study participants were asked to record the pain intensity score at the baseline, before the application of the desensitizing agents
Title
Level of Pain assessment with the Visual Analogue Scale (VAS)
Description
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.
Time Frame
All study participants were asked to record the pain intensity score at seven days after the application of the desensitizing agents
Title
Level of Pain assessment with the Visual Analogue Scale (VAS)
Description
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.
Time Frame
All study participants were asked to record the pain intensity score at one month after the application of the desensitizing agents
Title
Level of Pain assessment with the Visual Analogue Scale (VAS)
Description
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.
Time Frame
All study participants were asked to record the pain intensity score at two months after the application of the desensitizing agents
Title
Level of Pain assessment with the Visual Analogue Scale (VAS)
Description
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.
Time Frame
All study participants were asked to record the pain intensity score at six months after the application of the desensitizing agents
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Livia Ottolenghi, DDS,PhD
Organizational Affiliation
University of Roma La Sapienza
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Oral and Maxillo-Facial Sciences, Sapienza University of Rome
City
Rome
State/Province
RM
ZIP/Postal Code
00161
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34066300
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.
Results Reference
derived
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Effectiveness of a Bonding and a Fluoride Varnish for Long-term Dentin Hypersensitivity Treatment.
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