Efficacy of Universal Bonding Agents as Desensitizers

NCT07197437 | Completed

• 2 other identifiers: PKUSSIRB-202273039MR-11-22-005868
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dentin Hypersensitivity

Outcome Measures

Primary Outcomes (1)

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

  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.

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

Study Arms (2)

Single Bond Universal

EXPERIMENTAL

Use a microbrush to apply a drop of agent to the sensitive tooth surface for 20 seconds and light cure.

Device: Single Bond Universal as desensitizer

Hybrid Coat

ACTIVE COMPARATOR

Use a coated cotton pellet to apply a drop of agent to the sensitive tooth surface for 20 seconds and light cure.

Device: Hybrid Coat desensitizer

Interventions

Hybrid Coat desensitizer DEVICE

Dental desensitization treatment

Hybrid Coat

Single Bond Universal as desensitizer DEVICE

Dental desensitization treatment

Single Bond Universal

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Hospital of Stomatology: lead

Study Sites (1)

Peking University School and Hospital of Stomatology

Beijing, Beijing Municipality, 100081, China

Location

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Xue Cai

  Peking University School and Hospital of Stomatology

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: September 29, 2025
• Study Start: February 27, 2023
• Primary Completion: March 7, 2025
• Study Completion: March 7, 2025
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)