Fluoride Varnish X Glass Ionomer Sealant on Cervical Dentin Hypersensitivity

NCT04591444 | Completed Phase 3

• 1 other identifier: HDFOUSP
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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.

Conditions

Dentin Hypersensitivity; Dentin Sensitivity

Keywords

Dentin hypersensitivity; Dentin sensitivity; Hypersensitivity; Fluorides; Sodium fluoride; Glass ionomer sealant; Desensitizing treatment; Glass ionomer cement

Outcome Measures

Primary Outcomes (1)

• 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.

  4 weeks

Secondary Outcomes (2)

• Dentin hypersensitivity

  baseline, 15 minutes after the treatments, 1 week and 4 weeks.

• Change in the dentin hypersensitivity

  3 months and 6 months

Study Arms (3)

ClinproTM White Varnish

ACTIVE COMPARATOR

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).

Drug: Fluoride Varnish

ClinproTM XT Varnish

ACTIVE COMPARATOR

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).

Drug: Glass Ionomer Sealant

Placebo Group

PLACEBO COMPARATOR

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.

Other: Placebo Group

Interventions

Fluoride Varnish DRUG

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.

Also known as: ClinproTM White Varnish

ClinproTM White Varnish

Glass Ionomer Sealant DRUG

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.

Also known as: ClinproTM XT Varnish, Resin-modified Glass Ionomer Sealant

ClinproTM XT Varnish

Placebo Group OTHER

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.

Placebo Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

School of Dentistry, University of Sao Paulo

São Paulo, 05508-000, Brazil

Location

Related Publications (1)

• 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.

  PMID: 34676918 DERIVED

MeSH Terms

Conditions

Dentin Sensitivity; Hypersensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Immune System Diseases

Study Officials

• Taís Scaramucci Forlin, Assistant Professor

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The present study is a parallel, randomized, triple blind clinical trial.

Study Record Dates

• First Submitted: October 11, 2020
• First Posted: October 19, 2020
• Study Start: January 1, 2017
• Primary Completion: October 1, 2019
• Study Completion: March 1, 2020
• Last Updated: October 20, 2020

Record last verified: 2020-10

Locations

BR (1)