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Comparison of Dentin Hypersensitivity Reduction Over a 1-month Period

Primary Purpose

Dentin Sensitivity

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Gluma
fluoride varnish
Tetric N-Bond self-etch adhesive
Sponsored by
King Abdulaziz University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dentin Sensitivity focused on measuring Gluma, Desensitizing agent, Hypersensitivity

Eligibility Criteria

20 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • King Abdulaziz University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Tactile stimulus

Air blast stimulus

Cold stimulus

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
April 10, 2020
Last Updated
April 15, 2020
Sponsor
King Abdulaziz University
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1. Study Identification

Unique Protocol Identification Number
NCT04351412
Brief Title
Comparison of Dentin Hypersensitivity Reduction Over a 1-month Period
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 10, 2020 (Actual)
Primary Completion Date
February 9, 2020 (Actual)
Study Completion Date
February 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Abdulaziz University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentin Sensitivity
Keywords
Gluma, Desensitizing agent, Hypersensitivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized, double-blind, clinical trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tactile stimulus
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Air blast stimulus
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Cold stimulus
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Gluma
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
fluoride varnish
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Tetric N-Bond self-etch adhesive
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assess dentine hypersensitivity score to stimuli at Baseline
Description
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.
Time Frame
Baseline before treatment
Title
Assess dentine hypersensitivity score to stimuli immediately after treatment by intervention
Description
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.
Time Frame
From baseline to immediately after treatment with intervention
Title
Assess dentine hypersensitivity to stimuli at two-weeks follow up after treatment by intervention
Description
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.
Time Frame
From baseline to two-weeks follow up after treatment with intervention
Title
Assess dentine hypersensitivity to stimuli at one month follow up after treatment by intervention
Description
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.
Time Frame
From baseline to one month follow up after treatment with intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samar H Abuzinadah, DScD
Organizational Affiliation
Assistant Professor, Department of Restorative Dentistry, King Abdul-Aziz University, Jeddah, Saudi Arabia
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Abdulrahman J Alhaddad, DScD
Organizational Affiliation
Assistant Professor, Department of Oral and Maxillofacial Prosthodontics, King Abdul-Aziz University, Jeddah, Saudi Arabia
Official's Role
Study Director
Facility Information:
Facility Name
King Abdulaziz University
City
Jeddah
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33762645
Citation
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.
Results Reference
derived

Learn more about this trial

Comparison of Dentin Hypersensitivity Reduction Over a 1-month Period

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