Dentin HypersensitivityNCT04887181
The Effects of Different Dentin Hypersensitivity Treatment Methods on Quality of Life
A study testing Teethmate Desensitizer, Gluma Desensitizer and Hybrid Bond in people with Dentin Hypersensitivity, run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to evaluate the effects of a self etch adhesive resin and two desensitizing agents(Calcium phosphate, 5% glutaraldehyde) in treatment of dentin hypersensitivity on the quality of life of individuals. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dentin Hypersensitivity
- What is being tested?
- Teethmate Desensitizer, Gluma Desensitizer and Hybrid Bond
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Mar 2020to 1 Mar 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Not having any systemic disease,
- 18 years and older,
- At least one tooth complaining of dentin hypersensitivity (Schiff score> 1),
- The acceptance of the volunteers participating in the research.
Who cannot join
- Active periodontal disease,
- Periodontal surgery for the last 3 months,
- Use of desensitizing toothpaste or mouthwash in the last 3 months,
- Long-term use of analgesic and anti-inflammatory drugs,
- Having a history of allergies,
- Women during pregnancy or breastfeeding,
Show all 11Show fewer
- Parafunctional habits (bruxism, teeth grinding etc.),
- The presence of caries, pulpitis or restoration in teeth,
- Tooth tissue loss due to erosion, abrasion and abfraction,
- Congenital anomalies,
- Cracked teeth were not included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kırıkkale University Faculty of Dentistry, Department of Restorative Dentistry
Kirikkale, Yahşihan/Kırıkkale, 71450
About this study
The aim of this study was to evaluate the effects of a self etch adhesive resin and two desensitizing agents(Calcium phosphate, 5% glutaraldehyde) in treatment of dentin hypersensitivity on the quality of life of individuals.
Read the detailed description
This in-vivo study was done among 69 participants who reported at least one sensitivite tooth(Schiff Sensitivity Score >1) as a result of the clinical examination. Participants were randomly divided into three treatment groups(n=23):
- Tetracalcium phosphate and dicalcium phosphate containing desensitizer (Teethmate Desensitizer) II. %35 hydroxyethyl methacrylate and %5 glutaraldehyde containing desensitizer (Gluma Desensitizer) III. Self-etch adhesive resin (Hybrid Bond) These materials used in treatment of dentin hypersensitivity in 6 months clinical follow-up and the effects on the quality of life of individuals were evaluated with Dentine Hypersensitivity Experience Questionnaire (DHEQ).
- Conditions
- Dentin Hypersensitivity
- Being tested
- Teethmate Desensitizer, Gluma Desensitizer, Hybrid Bond
- Keywords
- Dentin Hypersensitivity, Desensitizing Agent, Adhesive Resin
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teethmate DesensitizerOther
Powder and liquid contained in the material were mixed. It was applied to the buccal surface of the sensitive tooth. then it was washed away from the tooth surface. 1-4 sessions were applied until the sensitivity disappeared.
Gluma DesensitizerOther
The material was applied to the buccal surface of the tooth with sensitivity. It was washed with water and removed from the tooth surface. 1-4 sessions were applied until the sensitivity disappeared.
Hybrid BondOther
It was applied to the buccal surface of the sensitive tooth with an applicator. It was cured with a LED light device. Dentin sensitivity was checked with evaporative air application. The process was repeated until the sensitivity disappeared.
| Study group | Role | What they receive |
|---|---|---|
| Teethmate Desensitizer | Active comparator | Tetracalcium phosphate and dicalcium phosphate containing desensitizer Receives: Other: Teethmate Desensitizer |
| Gluma Desensitizer | Active comparator | %35 hydroxyethyl methacrylate and %5 glutaraldehyde containing desensitizer Receives: Other: Gluma Desensitizer |
| Hybrid Bond | Active comparator | Self-etch adhesive resin Receives: Other: Hybrid Bond |
What is being measured
The primary outcome is the main question the study is designed to answer.
Schiff Cold Air Sensitivity Scale Scores
Average scores based on Schiff cold air sensitivity scale after evaporative air application. The Schiff score ranges from 0 to 3. Minimum value is 0, maximum value is 3. An increase in the score from 0 to 3 indicates an increase in sensitivity.
Measured: Before treatment, immediately after treatment, 1 week, 1 month, 3 month and 6 month
Visual Analog Scale(VAS) Scores
Average scores based on Visual Analog Scale(VAS) after applying evaporative air. The VAS score ranges from 0 to 10. The minimum value is 0 and the maximum value is 10. A score of 0 is defined as "no pain" while a score of 10 is defined as "intolerable pain".
Measured: Before treatment, immediately after treatment, 1 week, 1 month, 3 month and 6 month
Dentin Hypersensitivity Experience Questionnaire (DHEQ) scores
Data obtained after individuals complete the Dentin Hypersensitivity Experience Questionnaire. The decrease in the measured scores over time indicates that the quality of life has improved.
Measured: Change from baseline quality of life at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start4 Mar 2020
- Primary completion4 Sep 2020
- Study completion1 Mar 2021
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 HypersensitivityStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Behiye Esra Özdemir, Kırıkkale University
- Investigators
- Behiye Esra Özdemir, Res. Assist., Principal investigator, Kırıkkale University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04887181
- Sponsor's protocol ID
- 28/02
- Status last verified
- May 2021
- First submitted
- 5 May 2021
- Last updated
- 14 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD
Publications
Mason S, Burnett GR, Patel N, Patil A, Maclure R. Impact of toothpaste on oral health-related quality of life in people with dentine hypersensitivity. BMC Oral Health. 2019 Oct 22;19(1):226. doi: 10.1186/s12903-019-0919-x.
PubMed 31640741
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Different Dentin Hypersensitivity Treatment Methods on Quality of Life
- ClinicalTrials.gov ID
- NCT04887181
- Acronym / sponsor ID
- 28/02
- Conditions
- Dentin Hypersensitivity
- Keywords
- Dentin Hypersensitivity, Desensitizing Agent, Adhesive Resin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 4 Mar 2020 (actual)
- Primary completion
- 4 Sep 2020 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 14 May 2021 (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.
The aim of this study was to evaluate the effects of a self etch adhesive resin and two desensitizing agents(Calcium phosphate, 5% glutaraldehyde) in treatment of dentin hypersensitivity on the quality of life of individuals.
Detailed description
This in-vivo study was done among 69 participants who reported at least one sensitivite tooth(Schiff Sensitivity Score >1) as a result of the clinical examination. Participants were randomly divided into three treatment groups(n=23):
- Tetracalcium phosphate and dicalcium phosphate containing desensitizer (Teethmate Desensitizer) II. %35 hydroxyethyl methacrylate and %5 glutaraldehyde containing desensitizer (Gluma Desensitizer) III. Self-etch adhesive resin (Hybrid Bond) These materials used in treatment of dentin hypersensitivity in 6 months clinical follow-up and the effects on the quality of life of individuals were evaluated with Dentine Hypersensitivity Experience Questionnaire (DHEQ).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Teethmate Desensitizer | Active comparator | Other: Teethmate DesensitizerTetracalcium phosphate and dicalcium phosphate containing desensitizer |
| Gluma Desensitizer | Active comparator | Other: Gluma Desensitizer%35 hydroxyethyl methacrylate and %5 glutaraldehyde containing desensitizer |
| Hybrid Bond | Active comparator | Other: Hybrid BondSelf-etch adhesive resin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Not having any systemic disease,
- 18 years and older,
- At least one tooth complaining of dentin hypersensitivity (Schiff score> 1),
- The acceptance of the volunteers participating in the research.
Key exclusion criteria (11 listed)
- Active periodontal disease,
- Periodontal surgery for the last 3 months,
- Use of desensitizing toothpaste or mouthwash in the last 3 months,
- Long-term use of analgesic and anti-inflammatory drugs,
- Having a history of allergies,
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 |
|---|---|---|
| Teethmate DesensitizerPowder and liquid contained in the material were mixed. It was applied to the buccal surface of the sensitive tooth. then it was washed away from the tooth surface. 1-4 sessions were applied until the sensitivity disappeared. | Other | Teethmate Desensitizer |
| Gluma DesensitizerThe material was applied to the buccal surface of the tooth with sensitivity. It was washed with water and removed from the tooth surface. 1-4 sessions were applied until the sensitivity disappeared. | Other | Gluma Desensitizer |
| Hybrid BondIt was applied to the buccal surface of the sensitive tooth with an applicator. It was cured with a LED light device. Dentin sensitivity was checked with evaporative air application. The process was repeated until the sensitivity disappeared. | Other | Hybrid Bond |
Primary outcome
Schiff Cold Air Sensitivity Scale Scores
Time frame: Before treatment, immediately after treatment, 1 week, 1 month, 3 month and 6 month
Average scores based on Schiff cold air sensitivity scale after evaporative air application. The Schiff score ranges from 0 to 3. Minimum value is 0, maximum value is 3. An increase in the score from 0 to 3 indicates an increase in sensitivity.
Visual Analog Scale(VAS) Scores
Time frame: Before treatment, immediately after treatment, 1 week, 1 month, 3 month and 6 month
Average scores based on Visual Analog Scale(VAS) after applying evaporative air. The VAS score ranges from 0 to 10. The minimum value is 0 and the maximum value is 10. A score of 0 is defined as "no pain" while a score of 10 is defined as "intolerable pain".
Dentin Hypersensitivity Experience Questionnaire (DHEQ) scores
Time frame: Change from baseline quality of life at 6 months
Data obtained after individuals complete the Dentin Hypersensitivity Experience Questionnaire. The decrease in the measured scores over time indicates that the quality of life has improved.
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 14 May 2021.
- Results publication: PubMed 31640741Mason S, Burnett GR, Patel N, Patil A, Maclure R. Impact of toothpaste on oral health-related quality of life in people with dentine hypersensitivity. BMC Oral Health. 2019 Oct 22;19(1):226. doi: 10.1186/s12903-019-0919-x.
- Individual participant dataSharing planned: Yes. all collected IPD
Related trials for Dentin Hypersensitivity
Recruiting
A Study to Assess the Efficacy of a Calcium Sodium Phosphosilicate Toothpaste for the Relief of Dentine Hypersensitivity
Dentin Sensitivity
Active, not recruiting
Clinical Evaluation of Short Dentin Etching
Hypersensitivity Dentin, Dental Restoration Failure of Marginal Integrity
Recruiting
Peroxide Versus Non-Peroxide In-Office Tooth Bleaching
Tooth Discoloration, Tooth Staining
Recruiting
Dentine Hypersensitivity Using Dentine Adhesive With Strontium-doped Bioactive Glass-Ceramic
Dentine Hypersensitivity
Not yet recruiting
A Clinical Study to Assess the Efficacy of a Calcium Sodium Phosphosilicate Toothpaste for the Relief of Dentine Hypersensitivity
Dentin Sensitivity
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.
Behiye Esra Özdemir, Res. Assist. principal investigator
Kırıkkale University Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teethmate Desensitizer, Gluma Desensitizer and Hybrid Bond in people with Dentin Hypersensitivity, run by Kırıkkale University at 1 site in Turkey (Türkiye).
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 11 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 14 May 2021. 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 Turkey (Türkiye). 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?
Schiff Cold Air Sensitivity Scale Scores (time frame: Before treatment, immediately after treatment, 1 week, 1 month, 3 month and 6 month). The study lists 3 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 NCT04887181, 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 14 May 2021.