Dentin SensitivityNCT03083496
Clinical Evaluation of Different Potassium Oxalate Concentrations in Dentin Hypersensitivity Treatment
A study testing Potassium Oxalate 5% and Potassium Oxalate 10% in people with Dentin Sensitivity and Hypersensitivity Dentin, run by Federal University of Uberlandia at 1 site in Brazil.
Trial summary
This study aims to evaluate the longevity and efficacy of two products potassium oxalate-basedin two concentrations, 10% and 5%, by triple randomized blind clinical trial (split-mouth) . The desensitization approach (single agent) and the long-term effectiveness (baseline, 1 week, 2 weeks, 3 weeks). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Dentin Sensitivity, Hypersensitivity Dentin, Dentine Hypersensitivity
- What is being tested?
- Potassium Oxalate 5% and Potassium Oxalate 10%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteBrazil
- Study dates
- 14 Mar 2017to Feb 2018
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Healthy individuals
- Both genres, interested in the treatment of Dentin Hypersensitivity
- Patients with all teeth in their mouth
- Patients who have at least three teeth with Dentin hypersensitivity in different quadrants
- Good oral hygiene
Who cannot join
- Caries or unsatisfactory restorations
- Presence of periodontal disease and or parafunctional habits
- Cracks or enamel fractures
- Extensive or unsatisfactory restorations
- Recent restorations involving the labial surface
- Pulpitis
Show all 15Show fewer
- Dentures
- Orthodontics
- Smokers
- Pregnant women
- Gastroesophageal disease presence
- Uncontrolled systemic disease
- Severe bruxism
- Constant use of analgesic
- Allergic response to dental products
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Paulo V Soares
Uberlândia, Federal University of Uberlandia, 381440617
Paulo V Soares, DDS, MS, PHD, +55 34 991615642, paulovsoares@yahoo.com.br
About this study
Official title: Clinical Evaluation of Different Potassium Oxalate Concentrations in Dentin: A Randomized Clinical Trial
This study aims to evaluate the longevity and efficacy of two products potassium oxalate-basedin two concentrations, 10% and 5%, by triple randomized blind clinical trial (split-mouth) . The desensitization approach (single agent) and the long-term effectiveness (baseline, 1 week, 2 weeks, 3 weeks). Data will be collected, tabulated and submitted to statistical analysis.
Read the detailed description
Dentin hypersensitivity (DH) is characterized as a short, intense and sudden pain caused by thermal, chemical and evaporative stimuli. There are several types of desensitizing agents, used to aid in the control of this pathology, but they are not very effective and have short longevity. The agents based on potassium oxalate have been used by dental surgeons because they have mixed action, both neural and obliterating. Therefore, the aim of this study is through a triple blind randomized clinical trial (split-mouth), evaluate the longevity and efficacy of two products potassium oxalate-based in two concentrations, 10% and 5%. Thirty-two with DH at least 2 teeth and adequate oral hygiene will be randomly divided into two different groups according to the desensitization approach (10% and 5%) The dentin hypersensitivity level will be evaluated immediately after desensitization and after 1, 2 and 3. Data will be collected, tabulated and submitted to statistical analysis.
- Conditions
- Dentin Sensitivity, Hypersensitivity Dentin, Dentine Hypersensitivity, Dentin Hypersensitivity
- Being tested
- Potassium Oxalate 5%, Potassium Oxalate 10%
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Potassium Oxalate 5%Drug
Prophylaxis, apply uniformly on the teeth, friccion for 10 seconds, wait 10 minutes, remove the gel from the teeth with cotton and abundant water.
Potassium Oxalate 10%Drug
Prophylaxis, apply uniformly on the teeth, friccion for 10 seconds, wait 10 minutes, remove the gel from the teeth with cotton and abundant water.
| Study group | Role | What they receive |
|---|---|---|
| Potassium Oxalate 5% | Active comparator | Prophylaxis of the teeth; an application every 48 hours; 4 sessions Receives: Drug: Potassium Oxalate 5%; Drug: Potassium Oxalate 10% |
| Potassium Oxalate 10% | Active comparator | Prophylaxis of the teeth; an application every 48 hours; 4 sessions Receives: Drug: Potassium Oxalate 5%; Drug: Potassium Oxalate 10% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of cervical dentin hypersensitivity by using visual analog scale
Evaluation of the reduction in dentin hypersensitivity levels by using visual analog scale with a 3 weeks follow up.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2017
- Study start14 Mar 2017
- Primary completionJun 2017 (estimated)
- Study completionFeb 2018 (estimated)
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 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Uberlandia
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Fundação de Amparo à Pesquisa do estado de Minas Gerais
- Responsible party
- Principal investigator, PAULO VINICIUS SOARES, Federal University of Uberlandia
- Investigators
- Paulo V Soares, DDS,MS,PHD, Principal investigator, Federal University of Uberlandia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03083496
- Sponsor's protocol ID
- 61102016.0.0000.5152
- Status last verified
- Mar 2017
- First submitted
- 14 Mar 2017
- Last updated
- 20 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Grippo JO, Simring M, Coleman TA. Abfraction, abrasion, biocorrosion, and the enigma of noncarious cervical lesions: a 20-year perspective. J Esthet Restor Dent. 2012 Feb;24(1):10-23. doi: 10.1111/j.1708-8240.2011.00487.x. Epub 2011 Nov 17.
PubMed 22296690Gillam DG, Seo HS, Newman HN, Bulman JS. Comparison of dentine hypersensitivity in selected occidental and oriental populations. J Oral Rehabil. 2001 Jan;28(1):20-5. doi: 10.1046/j.1365-2842.2001.00631.x.
PubMed 11298905Canadian Advisory Board on Dentin Hypersensitivity. Consensus-based recommendations for the diagnosis and management of dentin hypersensitivity. J Can Dent Assoc. 2003 Apr;69(4):221-6.
PubMed 12662460Brannstrom M. Sensitivity of dentine. Oral Surg Oral Med Oral Pathol. 1966 Apr;21(4):517-26. doi: 10.1016/0030-4220(66)90411-7. No abstract available.
PubMed 5218158Cunha-Cruz J, Wataha JC, Zhou L, Manning W, Trantow M, Bettendorf MM, Heaton LJ, Berg J. Treating dentin hypersensitivity: therapeutic choices made by dentists of the northwest PRECEDENT network. J Am Dent Assoc. 2010 Sep;141(9):1097-105. doi: 10.14219/jada.archive.2010.0340.
PubMed 20807910Galvao ADM, Zeola LF, Moura GF, Teixeira DNR, Gonzaga RCQ, da Silva GR, Soares PV. A long-term evaluation of experimental potassium oxalate concentrations on dentin hypersensitivity reduction: A triple-blind randomized clinical trial. J Dent. 2019 Oct;89:103180. doi: 10.1016/j.jdent.2019.103180. Epub 2019 Aug 12.
PubMed 31415787
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Different Potassium Oxalate Concentrations in Dentin: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03083496
- Acronym / sponsor ID
- 61102016.0.0000.5152
- Conditions
- Dentin Sensitivity, Hypersensitivity Dentin, Dentine Hypersensitivity, Dentin Hypersensitivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Federal University of UberlandiaUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Fundação de Amparo à Pesquisa do estado de Minas Gerais
- Study start
- 14 Mar 2017 (actual)
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 20 Mar 2017 (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.
This study aims to evaluate the longevity and efficacy of two products potassium oxalate-basedin two concentrations, 10% and 5%, by triple randomized blind clinical trial (split-mouth) . The desensitization approach (single agent) and the long-term effectiveness (baseline, 1 week, 2 weeks, 3 weeks). Data will be collected, tabulated and submitted to statistical analysis.
Detailed description
Dentin hypersensitivity (DH) is characterized as a short, intense and sudden pain caused by thermal, chemical and evaporative stimuli. There are several types of desensitizing agents, used to aid in the control of this pathology, but they are not very effective and have short longevity. The agents based on potassium oxalate have been used by dental surgeons because they have mixed action, both neural and obliterating. Therefore, the aim of this study is through a triple blind randomized clinical trial (split-mouth), evaluate the longevity and efficacy of two products potassium oxalate-based in two concentrations, 10% and 5%. Thirty-two with DH at least 2 teeth and adequate oral hygiene will be randomly divided into two different groups according to the desensitization approach (10% and 5%) The dentin hypersensitivity level will be evaluated immediately after desensitization and after 1, 2 and 3. Data will be collected, tabulated and submitted to statistical analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Potassium Oxalate 5% | Active comparator | Drug: Potassium Oxalate 5%, Drug: Potassium Oxalate 10%Prophylaxis of the teeth; an application every 48 hours; 4 sessions |
| Potassium Oxalate 10% | Active comparator | Drug: Potassium Oxalate 5%, Drug: Potassium Oxalate 10%Prophylaxis of the teeth; an application every 48 hours; 4 sessions |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy individuals
- Both genres, interested in the treatment of Dentin Hypersensitivity
- Patients with all teeth in their mouth
- Patients who have at least three teeth with Dentin hypersensitivity in different quadrants
- Good oral hygiene
Key exclusion criteria (15 listed)
- Caries or unsatisfactory restorations
- Presence of periodontal disease and or parafunctional habits
- Cracks or enamel fractures
- Extensive or unsatisfactory restorations
- Recent restorations involving the labial surface
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 |
|---|---|---|
| Potassium Oxalate 5%Prophylaxis, apply uniformly on the teeth, friccion for 10 seconds, wait 10 minutes, remove the gel from the teeth with cotton and abundant water. | Drug | Potassium Oxalate 10%, Potassium Oxalate 5% |
| Potassium Oxalate 10%Prophylaxis, apply uniformly on the teeth, friccion for 10 seconds, wait 10 minutes, remove the gel from the teeth with cotton and abundant water. | Drug | Potassium Oxalate 10%, Potassium Oxalate 5% |
Primary outcome
Level of cervical dentin hypersensitivity by using visual analog scale
Time frame: 3 weeks
Evaluation of the reduction in dentin hypersensitivity levels by using visual analog scale with a 3 weeks follow up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2017.
- Background: PubMed 22296690Grippo JO, Simring M, Coleman TA. Abfraction, abrasion, biocorrosion, and the enigma of noncarious cervical lesions: a 20-year perspective. J Esthet Restor Dent. 2012 Feb;24(1):10-23. doi: 10.1111/j.1708-8240.2011.00487.x. Epub 2011 Nov 17.
- Background: PubMed 11298905Gillam DG, Seo HS, Newman HN, Bulman JS. Comparison of dentine hypersensitivity in selected occidental and oriental populations. J Oral Rehabil. 2001 Jan;28(1):20-5. doi: 10.1046/j.1365-2842.2001.00631.x.
- Background: PubMed 12662460Canadian Advisory Board on Dentin Hypersensitivity. Consensus-based recommendations for the diagnosis and management of dentin hypersensitivity. J Can Dent Assoc. 2003 Apr;69(4):221-6.
- Background: PubMed 5218158Brannstrom M. Sensitivity of dentine. Oral Surg Oral Med Oral Pathol. 1966 Apr;21(4):517-26. doi: 10.1016/0030-4220(66)90411-7. No abstract available.
- Background: PubMed 20807910Cunha-Cruz J, Wataha JC, Zhou L, Manning W, Trantow M, Bettendorf MM, Heaton LJ, Berg J. Treating dentin hypersensitivity: therapeutic choices made by dentists of the northwest PRECEDENT network. J Am Dent Assoc. 2010 Sep;141(9):1097-105. doi: 10.14219/jada.archive.2010.0340.
- Derived from this study: PubMed 31415787Galvao ADM, Zeola LF, Moura GF, Teixeira DNR, Gonzaga RCQ, da Silva GR, Soares PV. A long-term evaluation of experimental potassium oxalate concentrations on dentin hypersensitivity reduction: A triple-blind randomized clinical trial. J Dent. 2019 Oct;89:103180. doi: 10.1016/j.jdent.2019.103180. Epub 2019 Aug 12.
- 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.
Paulo V Soares, DDS,MS,PHD principal investigator
Federal University of Uberlandia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Potassium Oxalate 5% and Potassium Oxalate 10% in people with Dentin Sensitivity and Hypersensitivity Dentin, run by Federal University of Uberlandia at 1 site in Brazil.
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 15 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: status not confirmed, as of the sponsor's last update on 20 Mar 2017. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paulo V Soares, DDS,MS,PHD (381440617, paulovsoares@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of cervical dentin hypersensitivity by using visual analog scale (time frame: 3 weeks). 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 NCT03083496, 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 20 Mar 2017.