Dentin HypersensitivityPhase 2/3NCT02378129
Evaluation of Dentin Hypersensitivity Using Glass Ionomer Cements
A Phase 2/3 study testing Resin-modified glass ionomer cement Clinpro XT and Glass Ionomer cement Vidrion R in people with Dentin Hypersensitivity, run by Federal University of Pelotas.
Trial summary
The aim of this randomized, double-blind, split-mouth clinical trial is to evaluate and compare the desensitizing efficacies of the resin-modified glass ionomer cement ClinproTM XT (3M ESPE, Minnesota, USA) and the conventional glass ionomer cement Vidrion R (SS White, Gloucester, UK) at 2-year follow-up. Read more about this study
- Who is it for?
- Ages 28 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentin Hypersensitivity
- What is being tested?
- Resin-modified glass ionomer cement Clinpro XT and Glass Ionomer cement Vidrion R
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 2 Apr 2014to 1 Apr 2015
- Phase
- Phase 2/3
- 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 28 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female subjects between 18 and 70 years old
- At least 2 teeth with dentin hypersensitivity in two different hemiarchs
- Dental elements with hypersensitivity without any pulp alteration
- People who are not taking any medication and women who are not pregnant
- Patients without eating disorders or very acidic diets.
Who cannot join
- Teeth with hypersensitivity that presented extensive or unsatisfactory restorations, fractures, periodontal alterations, caries lesions, orthodontic brackets, endodontic treatments, pulp alterations.
- Subjects who received any desensitizing therapy during the last 3 months
- Subjects being under analgesics/anti-inflammatory drugs at the time of the study
- Teeth with hypersensitivity and non-carious cervical lesions
About this study
Official title: Evaluation of the Effectiveness of Dentin Hypersensitivity Treatment Using Glass Ionomer Cements: A Randomized Clinical Trial
The aim of this randomized, double-blind, split-mouth clinical trial is to evaluate and compare the desensitizing efficacies of the resin-modified glass ionomer cement ClinproTM XT (3M ESPE, Minnesota, USA) and the conventional glass ionomer cement Vidrion R (SS White, Gloucester, UK) at 2-year follow-up.
Read the detailed description
Subjects will require to have at least two teeth in different hemiarchs with dentin hypersensitivity. Teeth will be randomized into 2 groups, receiving either Clinpro XT or the conventional glass ionomer cement Vidrion R. Prior to the desensitizing treatment (baseline), painful symptoms will be assessed by tactile and air blast tests using the Visual Analogue Scale (VAS). Treatment evaluations will be conducted up to 2-year post-treatment.
- Conditions
- Dentin Hypersensitivity
- Being tested
- Resin-modified glass ionomer cement Clinpro XT, Glass Ionomer cement Vidrion R
- Keywords
- Dentin Sensitivity, Dentin Desensitizing Agents, Glass Ionomer Cements, Randomized Controlled Trial
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resin-modified glass ionomer cement Clinpro XTDrug
Also called Clinpro XT (3M Espe, USA)
Clinpro XT (3M ESPE, Minnesota, USA)
Glass Ionomer cement Vidrion RDrug
Also called Vidrion R (SS White, Gloucester, UK)
Vidrion R (SS White, Gloucester, UK)
| Study group | Role | What they receive |
|---|---|---|
| Clinpro XT (3M ESPE, Minnesota, USA) | Experimental | Resin-modified glass ionomer cement Receives: Drug: Resin-modified glass ionomer cement Clinpro XT |
| Vidrion R (SS White, Gloucester, UK) | Active comparator | Conventional glass ionomer cement Receives: Drug: Glass Ionomer cement Vidrion R |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores as measured by the Visual Analog Scale (VAS)
Tactile and air blast tests to evaluate pain with VAS
Measured: Change from Baseline in Pain Scores at 20 minutes; at 7, 15, 21, 30 days; and after 3, 6, 12, 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study start2 Apr 2014
- Primary completion1 Apr 2015
- Study completion1 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Pelotas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafael Guerra Lund, Federal University of Pelotas
- Investigators
- Rafael G Lund, PhD, Principal investigator, Federal University of Pelotas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02378129
- Sponsor's protocol ID
- UFPel
- Status last verified
- Aug 2020
- First submitted
- 22 Feb 2015
- Last updated
- 17 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: After completing the study, the 20 volunteers continued to be served sporadically at the regular dentistry service of the Faculty of Dentistry of Pelotas, Federal University of Pelotas (UFPel).
Publications
Lund RG, Silva AF, Piva E, Da Rosa WL, Heckmann SS, Demarco FF. Clinical evaluation of two desensitizing treatments in southern Brazil: A 3-month follow-up. Acta Odontol Scand. 2013 Nov;71(6):1469-74. doi: 10.3109/00016357.2013.770919. Epub 2013 Jul 3.
PubMed 24180588Brannstrom M. The hydrodynamics of the dental tubule and pulp fluid: its significance in relation to dentinal sensitivity. Annu Meet Am Inst Oral Biol. 1966;23:219. No abstract available.
PubMed 5228880da Rosa WL, Lund RG, Piva E, da Silva AF. The effectiveness of current dentin desensitizing agents used to treat dental hypersensitivity: a systematic review. Quintessence Int. 2013 Jul;44(7):535-46. doi: 10.3290/j.qi.a29610.
PubMed 23616976Que K, Guo B, Jia Z, Chen Z, Yang J, Gao P. A cross-sectional study: non-carious cervical lesions, cervical dentine hypersensitivity and related risk factors. J Oral Rehabil. 2013 Jan;40(1):24-32. doi: 10.1111/j.1365-2842.2012.02342.x. Epub 2012 Aug 7.
PubMed 22882712Orchardson R, Gillam DG. Managing dentin hypersensitivity. J Am Dent Assoc. 2006 Jul;137(7):990-8; quiz 1028-9. doi: 10.14219/jada.archive.2006.0321.
PubMed 16803826Madruga MM, Silva AF, Rosa WL, Piva E, Lund RG. Evaluation of dentin hypersensitivity treatment with glass ionomer cements: A randomized clinical trial. Braz Oral Res. 2017 Jan 5;31:e3. doi: 10.1590/1807-3107BOR-2017.vol31.0003.
PubMed 28076496
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Dentin Hypersensitivity Treatment Using Glass Ionomer Cements: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02378129
- Acronym / sponsor ID
- UFPel
- Conditions
- Dentin Hypersensitivity
- Keywords
- Dentin Sensitivity, Dentin Desensitizing Agents, Glass Ionomer Cements, Randomized Controlled Trial
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Federal University of PelotasUniversity, hospital or other
- Study start
- 2 Apr 2014 (actual)
- Primary completion
- 1 Apr 2015 (actual)
- Study completion
- 1 Apr 2015 (actual)
- First posted
- 4 Mar 2015 (estimated)
- 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 randomized, double-blind, split-mouth clinical trial is to evaluate and compare the desensitizing efficacies of the resin-modified glass ionomer cement ClinproTM XT (3M ESPE, Minnesota, USA) and the conventional glass ionomer cement Vidrion R (SS White, Gloucester, UK) at 2-year follow-up.
Detailed description
Subjects will require to have at least two teeth in different hemiarchs with dentin hypersensitivity. Teeth will be randomized into 2 groups, receiving either Clinpro XT or the conventional glass ionomer cement Vidrion R. Prior to the desensitizing treatment (baseline), painful symptoms will be assessed by tactile and air blast tests using the Visual Analogue Scale (VAS). Treatment evaluations will be conducted up to 2-year post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinpro XT (3M ESPE, Minnesota, USA) | Experimental | Drug: Resin-modified glass ionomer cement Clinpro XTResin-modified glass ionomer cement |
| Vidrion R (SS White, Gloucester, UK) | Active comparator | Drug: Glass Ionomer cement Vidrion RConventional glass ionomer cement |
Who may qualify
- Ages
- 28 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female subjects between 18 and 70 years old
- At least 2 teeth with dentin hypersensitivity in two different hemiarchs
- Dental elements with hypersensitivity without any pulp alteration
- People who are not taking any medication and women who are not pregnant
- Patients without eating disorders or very acidic diets.
Key exclusion criteria (4 listed)
- Teeth with hypersensitivity that presented extensive or unsatisfactory restorations, fractures, periodontal alterations, caries lesions, orthodontic brackets, endodontic treatments, pulp alterations.
- Subjects who received any desensitizing therapy during the last 3 months
- Subjects being under analgesics/anti-inflammatory drugs at the time of the study
- Teeth with hypersensitivity and non-carious cervical lesions
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 |
|---|---|---|
| Resin-modified glass ionomer cement Clinpro XTAlso: Clinpro XT (3M Espe, USA)Clinpro XT (3M ESPE, Minnesota, USA) | Drug | Clinpro XT (3M ESPE, Minnesota, USA) |
| Glass Ionomer cement Vidrion RAlso: Vidrion R (SS White, Gloucester, UK)Vidrion R (SS White, Gloucester, UK) | Drug | Vidrion R (SS White, Gloucester, UK) |
Primary outcome
Pain Scores as measured by the Visual Analog Scale (VAS)
Time frame: Change from Baseline in Pain Scores at 20 minutes; at 7, 15, 21, 30 days; and after 3, 6, 12, 24 months.
Tactile and air blast tests to evaluate pain with VAS
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 Aug 2020.
- Background: PubMed 24180588Lund RG, Silva AF, Piva E, Da Rosa WL, Heckmann SS, Demarco FF. Clinical evaluation of two desensitizing treatments in southern Brazil: A 3-month follow-up. Acta Odontol Scand. 2013 Nov;71(6):1469-74. doi: 10.3109/00016357.2013.770919. Epub 2013 Jul 3.
- Background: PubMed 5228880Brannstrom M. The hydrodynamics of the dental tubule and pulp fluid: its significance in relation to dentinal sensitivity. Annu Meet Am Inst Oral Biol. 1966;23:219. No abstract available.
- Background: PubMed 23616976da Rosa WL, Lund RG, Piva E, da Silva AF. The effectiveness of current dentin desensitizing agents used to treat dental hypersensitivity: a systematic review. Quintessence Int. 2013 Jul;44(7):535-46. doi: 10.3290/j.qi.a29610.
- Background: PubMed 22882712Que K, Guo B, Jia Z, Chen Z, Yang J, Gao P. A cross-sectional study: non-carious cervical lesions, cervical dentine hypersensitivity and related risk factors. J Oral Rehabil. 2013 Jan;40(1):24-32. doi: 10.1111/j.1365-2842.2012.02342.x. Epub 2012 Aug 7.
- Background: PubMed 16803826Orchardson R, Gillam DG. Managing dentin hypersensitivity. J Am Dent Assoc. 2006 Jul;137(7):990-8; quiz 1028-9. doi: 10.14219/jada.archive.2006.0321.
- Background: PubMed 28076496Madruga MM, Silva AF, Rosa WL, Piva E, Lund RG. Evaluation of dentin hypersensitivity treatment with glass ionomer cements: A randomized clinical trial. Braz Oral Res. 2017 Jan 5;31:e3. doi: 10.1590/1807-3107BOR-2017.vol31.0003.
- Individual participant dataSharing planned: No. After completing the study, the 20 volunteers continued to be served sporadically at the regular dentistry service of the Faculty of Dentistry of Pelotas, Federal University of Pelotas (UFPel).
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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.
Rafael G Lund, PhD principal investigator
Federal University of Pelotas
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Resin-modified glass ionomer cement Clinpro XT and Glass Ionomer cement Vidrion R in people with Dentin Hypersensitivity, run by Federal University of Pelotas.
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 5 inclusion and 4 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 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pain Scores as measured by the Visual Analog Scale (VAS) (time frame: Change from Baseline in Pain Scores at 20 minutes; at 7, 15, 21, 30 days; and after 3, 6, 12, 24 months.). 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 NCT02378129, which also lists 6 linked publications.
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 Aug 2020.