Clinical Evaluation of Different Potassium Oxalate Concentrations in Dentin Hypersensitivity Treatment

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.

Study Overview

• Status: Unknown
• Conditions: Dentin Sensitivity; Dentin Hypersensitivity; Dentine Hypersensitivity; Hypersensitivity Dentin
• Intervention / Treatment: Drug: Potassium Oxalate 5%; Drug: Potassium Oxalate 10%

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 Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paulo V Soares, DDS,MS,PHD; Phone Number: 381440617; Email: paulovsoares@yahoo.com.br

Study Locations

• Brazil
  • Federal University of Uberlandia
    • Uberlandia, Federal University of Uberlandia, Brazil, 381440617
      • Recruiting
      • Paulo V Soares
      • Contact: Paulo V Soares, DDS, MS, PHD; Phone Number: +55 34 991615642; Email: paulovsoares@yahoo.com.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Potassium Oxalate 5%; Prophylaxis of the teeth; an application every 48 hours; 4 sessions	Drug: 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%; Prophylaxis, apply uniformly on the teeth, friccion for 10 seconds, wait 10 minutes, remove the gel from the teeth with cotton and abundant water.
Active Comparator: Potassium Oxalate 10%; Prophylaxis of the teeth; an application every 48 hours; 4 sessions	Drug: 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%; Prophylaxis, apply uniformly on the teeth, friccion for 10 seconds, wait 10 minutes, remove the gel from the teeth with cotton and abundant water.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 weeks

Collaborators and Investigators

• Sponsor: Federal University of Uberlandia
• Collaborators: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.; Fundação de Amparo à Pesquisa do estado de Minas Gerais
• Investigators: Principal Investigator: Paulo V Soares, DDS,MS,PHD, Federal University of Uberlandia

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2017
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): February 1, 2018

Study Registration Dates

• First Submitted: March 14, 2017
• First Submitted That Met QC Criteria: March 14, 2017
• First Posted (Actual): March 20, 2017

Study Record Updates

• Last Update Posted (Actual): March 20, 2017
• Last Update Submitted That Met QC Criteria: March 14, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Stomatognathic Diseases; Tooth Diseases; Hypersensitivity; Dentin Sensitivity
• Other Study ID Numbers: 61102016.0.0000.5152

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No