Efficacy of Universal Bonding Agents as Desensitizers

Not Applicable

Completed

• Conditions: Dentin Hypersensitivity

• Registration Number: NCT07197437
• Lead Sponsor: Peking University Hospital of Stomatology

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.

Study Timeline

• Study Start: 2023-02-27
• Primary Completion: 2025-03-07
• Study Completion: 2025-03-07
• Status Verified: 2025-09
• Study First Submitted: 2025-09-15
• Study First Submitted QC: 2025-09-22
• Last Update Submitted: 2025-09-22
• Study First Posted: 2025-09-29
• Last Update Posted: 2025-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
treatment efficacy of the tooth: the change in VAS score before and after desensitization	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.

Trial Locations

Locations (1)

Peking University School and Hospital of Stomatology; 🇨🇳 Beijing, Beijing Municipality, China