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Completed

NCT Number: NCT07197437

Efficacy of Universal Bonding Agents as Desensitizers

The goal of this clinical trial is to learn if the adhesive Single Bond Universal works to treat dentin hypersensitivity in adults. It will also learn about the durability of Single Bond Universal. The main questions it aims to answer are:

Does Single Bond Universal has the function to treat dentin hypersensitivity in adults? Researchers will compare Single Bond Universal to a traditional desensitizer Hybrid Coat to see which one has higher efficiency and longer durability.

Participants will:

Receive the treatment of Single Bond Universal or Hybrid Coat at the first visit.

Visit the clinic at 1, 3, 6, 9, 12 months for follow-up evaluation. Reassess dentin sensitivity at each visit and record in terms of VAS score.

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Key information

Conditions

Dentin Hypersensitivity Dentin Sensitivity Stomatognathic Diseases Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University School and Hospital of Stomatology

Beijing, Beijing Municipality, 100081, China

About this study

This is a randomized, double-blind and controlled study to include 14 patients with dentin sensitivity. The study is a randomized controlled trial with split mouth control, with symmetrical tooth positions on both sides of the same patient as test and control groups, the test group being the group using the universal bonding agent and the control group being the group using the clinically used desensitizer (Hybrid Coat). Improvement in dentin sensitivity symptoms was the primary outcome indicator observed. Dentin sensitivity was assessed by evaluating the reduction in dentin sensitivity VAS scores at immediately, 1 month, 3 months, 6 months, 9 months and 12 months points after the desensitization treatment. Safety was assessed by evaluating appliance defects and adverse events at the same time points after the desensitization treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants aged ≥ 18 years who were able to provide written informed consent.
  • Participants confirmed as healthy according to the examiner, without clinically significant diseases that could interfere with study outcomes.
  • Participants with symptoms of dentin hypersensitivity affecting symmetrical teeth on both sides due to gingival recession.
  • Symptomatic teeth without caries, filling materials, or use as abutments for removable partial dentures.

Exclusion criteria

  • Individuals with dentin hypersensitivity caused by other factors (e.g., erosion or wedge-shaped defects).
  • Individuals with teeth exhibiting deep periodontal pockets (≥ 4 mm) or with a difference in gingival recession between the two symptomatic teeth of ≥ 1 mm.
  • Individuals who had received treatment or used toothpaste for dentin hypersensitivity within the previous 4 weeks.
  • Individuals who had undergone tooth bleaching or periodontal treatment within the previous 4 weeks.
  • Individuals who had undergone cervical restorative treatment. Individuals who had taken nonsteroidal anti-inflammatory drugs or narcotic analgesics within the previous week.

Treatment and study plan

Hybrid Coat desensitizer

Device

Dental desensitization treatment

Single Bond Universal as desensitizer

Device

Dental desensitization treatment

Primary outcomes

  1. treatment efficacy of the tooth: the change in VAS score before and after desensitization

    Time frame: from enrollment to the last follow-up (12 months after treatment)

    The severity of dentin sensitivity is assessed using visual analogue scale (VAS) with numbers 0-10 by participants after cold air stimulation. Beforehand, the participants were informed that the 10 cm VAS would be used to assess their pain sensitivity, with 0 indicating no pain and 10 indicating the worst pain. Lower scores on the VAS indicate lower sensitivity. Dentin sensitivity was considered to have improved if the visual pain scale (F-VAS) score decreased by 2 or more points from baseline.

Sponsors and collaborators

Lead sponsor

Peking University Hospital of Stomatology

Other

Registry information

Official study title

Clinical Efficacy of Resin Based Coating Materials for Protecting Dental Root

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 29, 2025
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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