Comparison of Dentin Hypersensitivity Reduction Over a 1-month Period

NCT04351412 | Completed

• 1 other identifier: 129-09-19
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Dentin Sensitivity

Keywords

Gluma; Desensitizing agent; Hypersensitivity

Outcome Measures

Primary Outcomes (4)

• Assess dentine hypersensitivity score to stimuli at Baseline

  Scores 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.

  Baseline before treatment

• Assess dentine hypersensitivity score to stimuli immediately after treatment by intervention

  Scores 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.

  From baseline to immediately after treatment with intervention

• Assess dentine hypersensitivity to stimuli at two-weeks follow up after treatment by intervention

  Scores 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.

  From baseline to two-weeks follow up after treatment with intervention

• Assess dentine hypersensitivity to stimuli at one month follow up after treatment by intervention

  Scores 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.

  From baseline to one month follow up after treatment with intervention

Study Arms (3)

Tactile stimulus

ACTIVE COMPARATOR

The tactile stimulus was examined using an explorer (# 17/23), passing at a right angle to the bucco-cervical tooth surface of concern. Contributors evaluated participants' pain score on a 10-point visual analogue scale (VAS). The stimulus was used to assess dentine hypersensitivity at baseline and immediately after completion of treatment. Subjects were also recalled for re-evaluation at 2 weeks and at 1 month after desensitizing treatment.

Other: Gluma; Other: fluoride varnish; Other: Tetric N-Bond self-etch adhesive

Air blast stimulus

ACTIVE COMPARATOR

For air blast stimuli, air was delivered by a three-way syringe from a typical dental unit air syringe at 40 psi (± 10 psi) and 70 °F (± 5 °F). The air flow was aimed at the tooth surface of concern, for 1 second, from a distance of 1 cm. The air blast stimulus scores were assessed by the Schiff Cold Air Sensitivity Scale 18. DH was assessed for air blast stimuli at baseline and immediately after completion of treatment. Subjects were also recalled for re-evaluation at 2 weeks and at 1 month after desensitizing treatment.

Other: Gluma; Other: fluoride varnish; Other: Tetric N-Bond self-etch adhesive

Cold stimulus

ACTIVE COMPARATOR

For cold hypersensitivity assessment, the tooth was isolated using cotton rolls; then, a few drops of extremely cold water were delivered to the tooth from a syringe that had previously been cooled. The cold stimulus scores were assessed by the Schiff Cold Air Sensitivity Scale 18. DH was assessed for cold stimulus at baseline and immediately after completion of treatment. Subjects were also recalled for re-evaluation at 2 weeks and at 1 month after desensitizing treatment.

Other: Gluma; Other: fluoride varnish; Other: Tetric N-Bond self-etch adhesive

Interventions

Gluma OTHER

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.

Air blast stimulus; Cold stimulus; Tactile stimulus

fluoride varnish OTHER

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.

Air blast stimulus; Cold stimulus; Tactile stimulus

Tetric N-Bond self-etch adhesive OTHER

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.

Air blast stimulus; Cold stimulus; Tactile stimulus

Eligibility Criteria

• Age: 20 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Abdulaziz University: lead

Study Sites (1)

King Abdulaziz University

Jeddah, Saudi Arabia

Location

Related Publications (1)

• Abuzinadah SH, Alhaddad AJ. A randomized clinical trial of dentin hypersensitivity reduction over one month after a single topical application of comparable materials. Sci Rep. 2021 Mar 24;11(1):6793. doi: 10.1038/s41598-021-86258-3.

  PMID: 33762645 DERIVED

MeSH Terms

Conditions

Dentin Sensitivity; Hypersensitivity

Interventions

Gluma

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Immune System Diseases

Study Officials

• Samar H Abuzinadah, DScD

  Assistant Professor, Department of Restorative Dentistry, King Abdul-Aziz University, Jeddah, Saudi Arabia

  STUDY CHAIR

• Abdulrahman J Alhaddad, DScD

  Assistant Professor, Department of Oral and Maxillofacial Prosthodontics, King Abdul-Aziz University, Jeddah, Saudi Arabia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: randomized, double-blind, clinical trial

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: April 17, 2020
• Study Start: January 10, 2020
• Primary Completion: February 9, 2020
• Study Completion: February 9, 2020
• Last Updated: April 17, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)