Clinical Trials Directory

Trials / Completed

CompletedNCT04351412

Comparison of Dentin Hypersensitivity Reduction Over a 1-month Period

Comparison of Dentin Hypersensitivity Reduction Over a 1-month Period Between a Single Topical Application of a Dentin-desensitizing Agent (Gluma) and Other Materials: A Randomized Clinical Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
55 (actual)
Sponsor
King Abdulaziz University · Academic / Other
Sex
All
Age
20 Years – 49 Years
Healthy volunteers
Accepted

Summary

Here we assessed the clinical effectiveness of Gluma, fluoride varnish, and the Tetric N-Bond one-step self-etch system in alleviating DH instantly and over 1 month, after a single topical application.A randomized, double-blind, clinical trial was conducted on 55 patients (25 males, 30 females; age: 20-49 years). Seventy teeth were randomly assigned to three groups: Gluma (n = 24); fluoride varnish (n = 23); and Tetric N-Bond adhesive (n = 23). Sensitivity to tactile, air blast, and cold stimuli were investigated.. A visual analogue scale was used to assess tactile stimuli, and the Schiff Cold Scale to assess air blast and cold stimuli. DH was evaluated immediately post-treatment, and at the 2-week and 1-month follow-up. Between-group and within-group comparisons were made.

Conditions

Interventions

TypeNameDescription
OTHERGlumaGluma is desensitizing agent by (Heraeus Kulzer, Armonk, NY, USA) claimed to treat dentine hypersensitivity in exposed cervical teeth surfaces and was applied to participants using a mini brush applicator tip onto the exposed hypersensitive tooth surface requiring treatment and was allowed to dry for 60 seconds. Then Dentine hypersensitivity (DH) was assessed for tactile, cold, and air blast stimuli immediately after completion of treatment. Subjects were also recalled for re-evaluation at 2 weeks and at 1 month after desensitizing treatment.
OTHERfluoride varnishfluoride varnish is usually applied to patients to prevent caries development but was claimed in some cases to also relief dentine hypersensitivity and was applied as a thin layer to the surface of the tooth using an applicator. The varnish set rapidly, and thereafter moisture contamination was not a concern. Patients were advised to not brush or floss their teeth for a couple of hours and to abstain from hot beverages. DH was assessed for tactile, cold, and air blast stimuli immediately after completion of treatment. Subjects were also recalled for re-evaluation at 2 weeks and at 1 month after desensitizing treatment.
OTHERTetric N-Bond self-etch adhesiveTetric N-Bond self-etch adhesive is one step dental adhesive and is also claimed to relief dentine hypersensitivity due to blockage of dentinal tubules. It was applied according to the manufacturer's instructions, in a thick layer, for at least 30 seconds, using a light brushing motion. Then, it was dried with a steady stream of air for 3 seconds and light-cured for 10 seconds. DH was assessed for tactile, cold, and air blast stimuli immediately after completion of treatment. Subjects were also recalled for re-evaluation at 2 weeks and at 1 month after desensitizing treatment.

Timeline

Start date
2020-01-10
Primary completion
2020-02-09
Completion
2020-02-09
First posted
2020-04-17
Last updated
2020-04-17

Locations

1 site across 1 country: Saudi Arabia

Source: ClinicalTrials.gov record NCT04351412. Inclusion in this directory is not an endorsement.