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Clinical Evaluation of Different Potassium Oxalate Concentrations in Dentin Hypersensitivity Treatment

Primary Purpose

Dentin Sensitivity, Hypersensitivity Dentin, Dentine Hypersensitivity

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Potassium Oxalate 5%
Potassium Oxalate 10%
Sponsored by
Federal University of Uberlandia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dentin Sensitivity

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Paulo V SoaresRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Potassium Oxalate 5%

Potassium Oxalate 10%

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 14, 2017
Last Updated
March 14, 2017
Sponsor
Federal University of Uberlandia
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Fundação de Amparo à Pesquisa do estado de Minas Gerais
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1. Study Identification

Unique Protocol Identification Number
NCT03083496
Brief Title
Clinical Evaluation of Different Potassium Oxalate Concentrations in Dentin Hypersensitivity Treatment
Official Title
Clinical Evaluation of Different Potassium Oxalate Concentrations in Dentin: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 14, 2017 (Actual)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
February 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Uberlandia
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Fundação de Amparo à Pesquisa do estado de Minas Gerais

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentin Sensitivity, Hypersensitivity Dentin, Dentine Hypersensitivity, Dentin Hypersensitivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Potassium Oxalate 5%
Arm Type
Active Comparator
Arm Description
Prophylaxis of the teeth; an application every 48 hours; 4 sessions
Arm Title
Potassium Oxalate 10%
Arm Type
Active Comparator
Arm Description
Prophylaxis of the teeth; an application every 48 hours; 4 sessions
Intervention Type
Drug
Intervention Name(s)
Potassium Oxalate 5%
Intervention Description
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
Intervention Name(s)
Potassium Oxalate 10%
Intervention Description
Prophylaxis, apply uniformly on the teeth, friccion for 10 seconds, wait 10 minutes, remove the gel from the teeth with cotton and abundant water.
Primary Outcome Measure Information:
Title
Level of cervical dentin hypersensitivity by using visual analog scale
Description
Evaluation of the reduction in dentin hypersensitivity levels by using visual analog scale with a 3 weeks follow up.
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paulo V Soares, DDS,MS,PHD
Phone
381440617
Email
paulovsoares@yahoo.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paulo V Soares, DDS,MS,PHD
Organizational Affiliation
Federal University of Uberlandia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Paulo V Soares
City
Uberlandia
State/Province
Federal University of Uberlandia
ZIP/Postal Code
381440617
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paulo V Soares, DDS, MS, PHD
Phone
+55 34 991615642
Email
paulovsoares@yahoo.com.br

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22296690
Citation
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.
Results Reference
background
PubMed Identifier
11298905
Citation
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.
Results Reference
background
PubMed Identifier
12662460
Citation
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.
Results Reference
background
PubMed Identifier
5218158
Citation
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.
Results Reference
background
PubMed Identifier
20807910
Citation
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.
Results Reference
background
PubMed Identifier
31415787
Citation
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.
Results Reference
derived

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Clinical Evaluation of Different Potassium Oxalate Concentrations in Dentin Hypersensitivity Treatment

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