Clinical Evaluation of Different Potassium Oxalate Concentrations in Dentin Hypersensitivity Treatment

NCT ID: NCT03083496

Last Updated: 2017-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-14

Study Completion Date

2018-02-28

Brief Summary

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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

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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

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Dentin Sensitivity Hypersensitivity Dentin Dentine Hypersensitivity Dentin Hypersensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Potassium Oxalate 5%

Prophylaxis of the teeth; an application every 48 hours; 4 sessions

Group Type ACTIVE_COMPARATOR

Potassium Oxalate 5%

Intervention Type 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%

Intervention Type 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%

Prophylaxis of the teeth; an application every 48 hours; 4 sessions

Group Type ACTIVE_COMPARATOR

Potassium Oxalate 5%

Intervention Type 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%

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* Dentures
* Orthodontics
* Smokers
* Pregnant women
* Gastroesophageal disease presence
* Uncontrolled systemic disease
* Severe bruxism
* Constant use of analgesic
* Allergic response to dental products
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

Sponsor Role collaborator

Fundação de Amparo à Pesquisa do estado de Minas Gerais

OTHER

Sponsor Role collaborator

Federal University of Uberlandia

OTHER

Sponsor Role lead

Responsible Party

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PAULO VINICIUS SOARES

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paulo V Soares, DDS,MS,PHD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Uberlandia

Locations

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Paulo V Soares

Uberlândia, Federal University of Uberlandia, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Paulo V Soares, DDS,MS,PHD

Role: CONTACT

381440617

Facility Contacts

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Paulo V Soares, DDS, MS, PHD

Role: primary

+55 34 991615642

References

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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.

Reference Type BACKGROUND
PMID: 22296690 (View on PubMed)

Gillam 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.

Reference Type BACKGROUND
PMID: 11298905 (View on PubMed)

Canadian 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.

Reference Type BACKGROUND
PMID: 12662460 (View on PubMed)

Brannstrom 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.

Reference Type BACKGROUND
PMID: 5218158 (View on PubMed)

Cunha-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.

Reference Type BACKGROUND
PMID: 20807910 (View on PubMed)

Galvao 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.

Reference Type DERIVED
PMID: 31415787 (View on PubMed)

Other Identifiers

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61102016.0.0000.5152

Identifier Type: -

Identifier Source: org_study_id

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