Effectiveness of Two Different Desensitizing Dental Varnishes

NCT07622043 | Not Yet Recruiting

• 1 other identifier: OTCS 524967700
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Dental varnishes are commonly used to relieve dentin hypersensitivity by forming a protective film that occludes dentinal tubules and reduces fluid flow. This clinical investigation aims to compare the desensitizing effect of a fluoride containing varnish with a fluoride free placebo varnish. Primary and secondary objectives include evaluating short and long term reductions in dentinal hypersensitivity, assessing patient reported outcomes and daily experiences, and monitoring the varnish's tolerability and safety.

Conditions

Dentin Hypersensitivity; Dentin Desensitizing Agents

Outcome Measures

Primary Outcomes (1)

• Reduction of dentin hypersensitivity

  assessed by patient response to an air stimulus using a pain scale (grades 0-4, lower scores mean a better outcome)

  1 week

Study Arms (2)

Fluoride-containing varnish

EXPERIMENTAL

A fluoride-containing varnish is applied to a tooth that is hypersensitive.

Device: Fluoride-containing varnish

Fluoride-free varnish

PLACEBO COMPARATOR

A fluoride-free varnish is applied to a tooth that is hypersensitive.

Device: Fluoride-free varnish

Interventions

Fluoride-containing varnish DEVICE

A fluoride-containing varnish is applied to a tooth that is hypersensitive.

Fluoride-containing varnish

Fluoride-free varnish DEVICE

A fluoride-free varnish is applied to a tooth that is hypersensitive.

Fluoride-free varnish

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed Consent signed by the subject
• Age: 18-65 years
• Hypersensitivity assessment scale ≥ Grade 2 in
• two non-neighboring teeth in different quadrants
• The affected teeth are/have: vital, caries-free, received no restorations within the last month
• No change in medication anticipated over the next 3 months (e.g. due to upcoming surgery etc.)

You may not qualify if:

• Contraindications and limitations of the MD as described in the instructions for use.
• Known hypersensitivity or allergy to the device material (especially acrylates, mint flavouring)
• Pregnant or other vulnerable subjects
• Participants with severe systemic disease
• Enrolment of employees of the dental clinic of Ivoclar Vivadent AG
• Recent change in medication concerning Analgesics, NSAIDs, psychotropic drugs, other medications that may alter pain perception
• Intake of analgesics prior to appointment
• Professional desensitizing therapy in the last 3 months
• Bleaching procedures in the last 4 weeks
• Confounding dental conditions at test sites: defective or extensive restorations, abutment teeth for prostheses, recent restorations, pulpitis/periapical pathology.
• Current or recent use of desensitizing toothpastes or mouthrinses (i.e. products specifically marketed for the treatment of dentin hypersensitivity) within 4 weeks prior to enrolment

Sponsors & Collaborators

• Ivoclar Vivadent AG: lead

Study Sites (1)

Internal Clinic Ivoclar Vivadent AG

Schaan, 9494, Liechtenstein

Location

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: split-mouth design: 2 hypersensitive teeth are treated per participant (test and control treatment in the same patient)

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 2, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1)