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Fluoride Varnish X Glass Ionomer Sealant on Cervical Dentin Hypersensitivity

Primary Purpose

Dentin Hypersensitivity, Dentin Sensitivity

Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Fluoride Varnish
Glass Ionomer Sealant
Placebo Group
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dentin Hypersensitivity focused on measuring Dentin hypersensitivity, Dentin sensitivity, Hypersensitivity, Fluorides, Sodium fluoride, Glass ionomer sealant, Desensitizing treatment, Glass ionomer cement

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Minimum age of 18 years old;
  • Presented good general health;
  • Presented at least one tooth with DH reported in the cervical region, which has a graded sensitivity of 4 or more on the VAS scale.

Exclusion Criteria:

  • Presented active caries lesions or with defective restorations in the tooth to be analyzed;
  • Presented enough dentin loss that required restorative treatment or periodontal surgery;
  • Volunteers who underwent any professional desensitizing treatment in the last 6 months;
  • Volunteers who used desensitizing pastes in the 3 months;
  • Volunteers who were using anti-inflammatory or analgesic drugs at the time of recruitment;
  • Volunteers were are pregnant or breastfeeding.

Sites / Locations

  • School of Dentistry, University of Sao Paulo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

ClinproTM White Varnish

ClinproTM XT Varnish

Placebo Group

Arm Description

Application of ClinproTM White Varnish containing sodium fluoride (5%) and Tricalcium phosphate (TCP). A technology that allows calcium and phosphate ions to coexist with fluoride ions separately, forming a more resistant mineral on the tooth surface (3M ESPE Clinpro White Varnish; 3M ESPE Clinpro 5000).

Application of ClinproTM XT Varnish, a resin-modified glass ionomer sealant. Creates a protective layer on exposed dentin, which is durable and has the ability to release fluoride, calcium and phosphate into the surroundings. (3M ESPE Clinpro XT Varnish).

Participants who were part of the placebo group continuously used only the conventional toothpaste provided in the oral hygiene kit during the initial four weeks of the research and received a simulated treatment.

Outcomes

Primary Outcome Measures

Change in the dentin hypersensitivity
The evaluation was performed with the use of Visual Analog Scale (VAS). The volunteers pointed out on the VAS (ranging from 0=no pain to 10=worst possible pain) the whole number, which best described his perception of pain at the moment. The primary outcome was the difference between the Visual Analog Scale values obtained in the baseline and 4 weeks after the treatment.

Secondary Outcome Measures

Dentin hypersensitivity
This secondary outcome was the Visual Analog Scale (VAS) score related to dentin hypersensitivity. The volunteers pointed out on the VAS (ranging from 0=no pain to 10=worst possible pain) the whole number, which best described his perception of pain at the moment. Visual Analog Scale was applied before the treatment (baseline), 15 minutes after the procedures, one week, and 4 weeks after treatments to measure the changes in dentin hypersensitivity.
Change in the dentin hypersensitivity
The evaluation was performed with the use of Visual Analog Scale (VAS). The volunteers pointed out on the VAS (ranging from 0=no pain to 10=worst possible pain) the whole number, which best described his perception of pain at the moment. This secondary outcome was the difference between the Visual Analog Scale values obtained in the baseline and 3 and 6 months after the treatment (Long-term differences in the VAS values).

Full Information

First Posted
October 11, 2020
Last Updated
October 16, 2020
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT04591444
Brief Title
Fluoride Varnish X Glass Ionomer Sealant on Cervical Dentin Hypersensitivity
Official Title
Efficacy of a Fluoride Varnish and a Glass Ionomer Sealant on Cervical Dentin Hypersensitivity: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
October 2019 (Actual)
Study Completion Date
March 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Dentin hypersensitivity (DH) can be defined as acute, short-duration pain from open dentin tubules in exposed dentin. The symptom of DH is subjective and varies from patient to patient and may present as mild discomfort or as a high-intensity pain, which can affect the individual's quality of life, interfering with their eating and hygiene habits. One approach to treatment would be the use of agents that chemically desensitize sensory nerves, blocking the transmission of nerve stimuli to the central nervous system. The effectiveness of desensitizing treatments is influenced by several factors present in the oral cavity, which can contribute to a greater effect of these agents but can also be responsible for removing them from the dental surface. To date, studies have been carried out in the short term, not exceeding an average period of 12 weeks, so there is no consensus on the technique or agent that will guarantee the most effective and lasting effect against DH, not even the ideal period for reapplication. Thus, more studies are needed to assess the clinical behavior of desensitizing products on the market, especially the most recent releases. Therefore, the aim of this study was to clinically compare the effectiveness of different office treatments for DH, being ClinproTM White Varnish, ClinproTM XT Varnish, and a control group (placebo) through pain assessment with the Visual Analog Scale (VAS), after stimulation with air from the triple syringe.
Detailed Description
This study compares the effectiveness of two in-office treatment for dentin hypersensitivity: G1:ClinproTM White Varnish, G2:ClinproTM XT Varnish, and a G3:placebo (where the application of a product was only simulated). Recruitment of the 121 volunteers were based on their self-reported complaint of dentin hypersensitivity, which confirmed with the use of an air blast from a triple syringe. Then, he/she showed in the VAS scale (which varies from 0=no pain to 10=the worst pain possible) the value that best describes the pain sensation. The subjects that present at least one tooth with a value of 4 and above in the VAS scale (if more than one hypersensitive tooth was present, the mean VAS values obtained were used, for each patient) was randomly allocated into the experimental groups. Two weeks before the study started, the volunteers went through a wash out period, where they used only the oral hygiene products donated by the researchers, which were used up to the end of the study. The in-office treatments were performed after prophylaxis, according to the manufacturer´s instructions, by one trained researcher, which was blind to the treatments. DH evaluation was performed 15 min after the application of the treatments, by a different researcher, which also blind to the treatment, and which used the same methodology described early for the detection of initial pain. The volunteers were recalled for the DH evaluation after one and four weeks of the treatments. DH evaluation was also performed after 12 and 24 weeks of the treatments, except in the placebo group, which received the proper DH treatment after the first four weeks of the study. Data was analyzed with the appropriate statistical methods (α=0.05).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentin Hypersensitivity, Dentin Sensitivity
Keywords
Dentin hypersensitivity, Dentin sensitivity, Hypersensitivity, Fluorides, Sodium fluoride, Glass ionomer sealant, Desensitizing treatment, Glass ionomer cement

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
The present study is a parallel, randomized, triple blind clinical trial.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ClinproTM White Varnish
Arm Type
Active Comparator
Arm Description
Application of ClinproTM White Varnish containing sodium fluoride (5%) and Tricalcium phosphate (TCP). A technology that allows calcium and phosphate ions to coexist with fluoride ions separately, forming a more resistant mineral on the tooth surface (3M ESPE Clinpro White Varnish; 3M ESPE Clinpro 5000).
Arm Title
ClinproTM XT Varnish
Arm Type
Active Comparator
Arm Description
Application of ClinproTM XT Varnish, a resin-modified glass ionomer sealant. Creates a protective layer on exposed dentin, which is durable and has the ability to release fluoride, calcium and phosphate into the surroundings. (3M ESPE Clinpro XT Varnish).
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Participants who were part of the placebo group continuously used only the conventional toothpaste provided in the oral hygiene kit during the initial four weeks of the research and received a simulated treatment.
Intervention Type
Drug
Intervention Name(s)
Fluoride Varnish
Other Intervention Name(s)
ClinproTM White Varnish
Intervention Description
Following the manufacturer's recommendations, it was not necessary to moisten or dry the treated surface beforehand or afterwards. The product was dispensed and manipulated for 15 s until a homogeneous mixture was obtained, applied with a micro brush, flowing into interproximal areas, and quickly adhering to the tooth surface in the presence of saliva.
Intervention Type
Drug
Intervention Name(s)
Glass Ionomer Sealant
Other Intervention Name(s)
ClinproTM XT Varnish, Resin-modified Glass Ionomer Sealant
Intervention Description
Following the manufacturer's recommendations, prophylaxis and prior drying of the treated surface was carried out, the product was also dispensed and manipulated for 15 s until a homogeneous mixture was obtained, applied with a micro brush and light-cured for 20 s.
Intervention Type
Other
Intervention Name(s)
Placebo Group
Intervention Description
4 weeks after the simulation of the treatment application, participants in the placebo group received DH treatment with the product that had the best effect in the first 4 weeks.
Primary Outcome Measure Information:
Title
Change in the dentin hypersensitivity
Description
The evaluation was performed with the use of Visual Analog Scale (VAS). The volunteers pointed out on the VAS (ranging from 0=no pain to 10=worst possible pain) the whole number, which best described his perception of pain at the moment. The primary outcome was the difference between the Visual Analog Scale values obtained in the baseline and 4 weeks after the treatment.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Dentin hypersensitivity
Description
This secondary outcome was the Visual Analog Scale (VAS) score related to dentin hypersensitivity. The volunteers pointed out on the VAS (ranging from 0=no pain to 10=worst possible pain) the whole number, which best described his perception of pain at the moment. Visual Analog Scale was applied before the treatment (baseline), 15 minutes after the procedures, one week, and 4 weeks after treatments to measure the changes in dentin hypersensitivity.
Time Frame
baseline, 15 minutes after the treatments, 1 week and 4 weeks.
Title
Change in the dentin hypersensitivity
Description
The evaluation was performed with the use of Visual Analog Scale (VAS). The volunteers pointed out on the VAS (ranging from 0=no pain to 10=worst possible pain) the whole number, which best described his perception of pain at the moment. This secondary outcome was the difference between the Visual Analog Scale values obtained in the baseline and 3 and 6 months after the treatment (Long-term differences in the VAS values).
Time Frame
3 months and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Minimum age of 18 years old; Presented good general health; Presented at least one tooth with DH reported in the cervical region, which has a graded sensitivity of 4 or more on the VAS scale. Exclusion Criteria: Presented active caries lesions or with defective restorations in the tooth to be analyzed; Presented enough dentin loss that required restorative treatment or periodontal surgery; Volunteers who underwent any professional desensitizing treatment in the last 6 months; Volunteers who used desensitizing pastes in the 3 months; Volunteers who were using anti-inflammatory or analgesic drugs at the time of recruitment; Volunteers were are pregnant or breastfeeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taís Scaramucci Forlin, Assistant Professor
Organizational Affiliation
University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Dentistry, University of Sao Paulo
City
Sao Paulo
ZIP/Postal Code
05508-000
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
34676918
Citation
Machado AC, Maximiano V, Yoshida ML, Freitas JG, Mendes FM, Aranha ACC, Scaramucci T. Efficacy of a calcium-phosphate/fluoride varnish and ionomeric sealant on cervical dentin hypersensitivity: A randomized, double-blind, placebo-controlled clinical study. J Oral Rehabil. 2022 Jan;49(1):62-70. doi: 10.1111/joor.13270. Epub 2021 Nov 2.
Results Reference
derived

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Fluoride Varnish X Glass Ionomer Sealant on Cervical Dentin Hypersensitivity

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