Efficacy of Universal Bonding Agents as Desensitizers

NCT ID: NCT07197437

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-27
• Study Completion Date: 2025-03-07

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.

Detailed Description

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.

Conditions

Dentin Hypersensitivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Single Bond Universal

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

Group Type: EXPERIMENTAL

Single Bond Universal as desensitizer

Intervention Type: DEVICE

Dental desensitization treatment

Hybrid Coat

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

Group Type: ACTIVE_COMPARATOR

Hybrid Coat desensitizer

Intervention Type: DEVICE

Dental desensitization treatment

Interventions

Hybrid Coat desensitizer

Dental desensitization treatment

Intervention Type: DEVICE

Single Bond Universal as desensitizer

Dental desensitization treatment

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Participants aged ≥ 18 years who were able to provide written informed consent.

2. Participants confirmed as healthy according to the examiner, without clinically significant diseases that could interfere with study outcomes.

3. Participants with symptoms of dentin hypersensitivity affecting symmetrical teeth on both sides due to gingival recession.

4. Symptomatic teeth without caries, filling materials, or use as abutments for removable partial dentures.

Exclusion Criteria

1. Individuals with dentin hypersensitivity caused by other factors (e.g., erosion or wedge-shaped defects).

2. Individuals with teeth exhibiting deep periodontal pockets (≥ 4 mm) or with a difference in gingival recession between the two symptomatic teeth of ≥ 1 mm.

3. Individuals who had received treatment or used toothpaste for dentin hypersensitivity within the previous 4 weeks.

4. Individuals who had undergone tooth bleaching or periodontal treatment within the previous 4 weeks.

5. Individuals who had undergone cervical restorative treatment. Individuals who had taken nonsteroidal anti-inflammatory drugs or narcotic analgesics within the previous week.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Hospital of Stomatology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xue Cai

Role: PRINCIPAL_INVESTIGATOR

Peking University School and Hospital of Stomatology

Locations

Peking University School and Hospital of Stomatology

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

PKUSSIRB-202273039

Identifier Type: OTHER

Identifier Source: secondary_id

MR-11-22-005868

Identifier Type: OTHER

Identifier Source: secondary_id

PKUSSIRB-202273039

Identifier Type: -

Identifier Source: org_study_id