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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04351412
Enrollment
55
Registered
2020-04-17
Start date
2020-01-10
Completion date
2020-02-09
Last updated
2020-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dentin Sensitivity

Keywords

Gluma, Desensitizing agent, Hypersensitivity

Brief 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.

Interventions

OTHERGluma

Gluma 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 varnish

fluoride 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 adhesive

Tetric 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.

Sponsors

King Abdulaziz University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

randomized, double-blind, clinical trial

Eligibility

Sex/Gender
ALL
Age
20 Years to 49 Years
Healthy volunteers
Yes

Inclusion criteria

* Middle-aged adult population who usually complains of Dentin Hypersensitivity. * Age range 20-49 years, that visit the dental hospital at King Abdul-Aziz university (KAUDH) who would have at least one or two teeth with DH * Those with recession of the gingiva, teeth erosion or abrasion. * Patients agreed to participate in the study.

Exclusion criteria

* Patients going through professional desensitizing treatment during the previous three months; Using desensitizing tooth paste in the last two months * Chronic; far on progress periodontal disease; treatment for periodontal disease; * Teeth with ICDAS (International Caries Detection and Assessment System) score 4 * Teeth diagnosed for irreversible pulpitis; root canal treated teeth * Teeth covered with crowns; bridge * Teeth with cervical restorations interfering with the evaluation * Medically compromised patients currently using medications like anticonvulsants, antihistamines, antidepressants, sedatives or daily analgesics. * Pregnant or lactating women; were also excluded.

Design outcomes

Primary

MeasureTime frameDescription
Assess dentine hypersensitivity score to stimuli at BaselineBaseline before treatmentScores of DH for tactile stimulus were recorded using visual analogue scale and for cold, and air blast stimuli using the Schiff Cold Air Sensitivity Scale 18 at baseline.
Assess dentine hypersensitivity score to stimuli immediately after treatment by interventionFrom baseline to immediately after treatment with interventionScores of DH for tactile stimulus were recorded using visual analogue scale and for cold, and air blast stimuli using the Schiff Cold Air Sensitivity Scale 18 were recorded immediately after treatment with intervention and compared score to baseline.
Assess dentine hypersensitivity to stimuli at two-weeks follow up after treatment by interventionFrom baseline to two-weeks follow up after treatment with interventionScores of DH for tactile stimulus were recorded using visual analogue scale and for cold, and air blast stimuli using the Schiff Cold Air Sensitivity Scale 18 were recorded at two-weeks follow up after treatment with intervention and compared score to baseline and immediate treatment scores.
Assess dentine hypersensitivity to stimuli at one month follow up after treatment by interventionFrom baseline to one month follow up after treatment with interventionScores of DH for tactile stimulus were recorded using visual analogue scale and for cold, and air blast stimuli using the Schiff Cold Air Sensitivity Scale 18 were recorded at one month (30 days) follow up after treatment with intervention and compared score to baseline and immediate treatment, and two weeks follow up visit scores.

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026