Dentin SensitivityNCT04351412
Comparison of Dentin Hypersensitivity Reduction Over a 1-month Period
A study testing Gluma, fluoride varnish and Tetric N-Bond self-etch adhesive in people with Dentin Sensitivity, run by King Abdulaziz University at 1 site in Saudi Arabia.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentin Sensitivity
- What is being tested?
- Gluma, fluoride varnish and Tetric N-Bond self-etch adhesive
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 10 Jan 2020to 9 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Gluma, fluoride varnish, Tetric N-Bond self-etch adhesive
- Keywords
- Gluma, Desensitizing agent, Hypersensitivity
- Medical subject headings
- Dentin Sensitivity, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlumaOther
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.
fluoride varnishOther
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.
Tetric N-Bond self-etch adhesiveOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Gluma; Other: fluoride varnish; Other: Tetric N-Bond self-etch adhesive |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline to one month follow up after treatment with intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start10 Jan 2020
- Primary completion9 Feb 2020
- Study completion9 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dentin SensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, double-blind, clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Samar Abuzinadah, King Abdulaziz University
- Investigators
- Samar H Abuzinadah, DScD, Study chair, Assistant Professor, Department of Restorative Dentistry, King Abdul-Aziz University, Jeddah, Saudi ArabiaAbdulrahman J Alhaddad, DScD, Study director, Assistant Professor, Department of Oral and Maxillofacial Prosthodontics, King Abdul-Aziz University, Jeddah, Saudi Arabia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04351412
- Sponsor's protocol ID
- 129-09-19
- Status last verified
- Apr 2020
- First submitted
- 10 Apr 2020
- Last updated
- 17 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33762645
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04351412
- Acronym / sponsor ID
- 129-09-19
- Conditions
- Dentin Sensitivity
- Keywords
- Gluma, Desensitizing agent, Hypersensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 9 Feb 2020 (actual)
- Study completion
- 9 Feb 2020 (actual)
- First posted
- 17 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- randomized, double-blind, clinical trial
| Arm | Type | Receives |
|---|---|---|
| Tactile stimulus | Active comparator | Other: Gluma, Other: fluoride varnish, Other: Tetric N-Bond self-etch adhesiveThe 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. |
| Air blast stimulus | Active comparator | Other: Gluma, Other: fluoride varnish, Other: Tetric N-Bond self-etch adhesiveFor 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. |
| Cold stimulus | Active comparator | Other: Gluma, Other: fluoride varnish, Other: Tetric N-Bond self-etch adhesiveFor 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. |
Who may qualify
- Ages
- 20 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlumaGluma 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. | Other | Air blast stimulus, Cold stimulus, Tactile stimulus |
| fluoride 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. | Other | Air blast stimulus, Cold stimulus, Tactile stimulus |
| Tetric 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. | Other | Air blast stimulus, Cold stimulus, Tactile stimulus |
Primary outcome
Assess dentine hypersensitivity score to stimuli at Baseline
Time frame: Baseline before treatment
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
Time frame: From baseline to immediately after treatment with 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
Time frame: From baseline to two-weeks follow up after treatment with 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
Time frame: From baseline to one month follow up after treatment with 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2020.
- Derived from this study: PubMed 33762645Abuzinadah 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samar H Abuzinadah, DScD study chair
Assistant Professor, Department of Restorative Dentistry, King Abdul-Aziz University, Jeddah, Saudi Arabia
Abdulrahman J Alhaddad, DScD study director
Assistant Professor, Department of Oral and Maxillofacial Prosthodontics, King Abdul-Aziz University, Jeddah, Saudi Arabia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gluma, fluoride varnish and Tetric N-Bond self-etch adhesive in people with Dentin Sensitivity, run by King Abdulaziz University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess dentine hypersensitivity score to stimuli at Baseline (time frame: Baseline before treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04351412, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2020.