Clinical Evaluation of Different Potassium Oxalate Concentrations in Dentin Hypersensitivity Treatment

NCT03083496 | Unknown

• 1 other identifier: 61102016.0.0000.5152
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Dentin Sensitivity; Hypersensitivity Dentin; Dentine Hypersensitivity; Dentin Hypersensitivity

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Potassium Oxalate 5%

ACTIVE COMPARATOR

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

Drug: Potassium Oxalate 5%; Drug: Potassium Oxalate 10%

Potassium Oxalate 10%

ACTIVE COMPARATOR

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

Drug: Potassium Oxalate 5%; Drug: Potassium Oxalate 10%

Interventions

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%; Potassium Oxalate 5%

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.

Potassium Oxalate 10%; Potassium Oxalate 5%

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of Uberlandia: lead
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator
• Fundação de Amparo à Pesquisa do estado de Minas Gerais: collaborator

Study Sites (1)

Paulo V Soares

Uberlândia, Federal University of Uberlandia, 381440617, Brazil

RECRUITING

Related Publications (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.

  PMID: 22296690 BACKGROUND

• 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.

  PMID: 11298905 BACKGROUND

• 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.

  PMID: 12662460 BACKGROUND

• 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.

  PMID: 5218158 BACKGROUND

• 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.

  PMID: 20807910 BACKGROUND

• 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.

  PMID: 31415787 DERIVED

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Paulo V Soares, DDS,MS,PHD

  Federal University of Uberlandia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paulo V Soares, DDS,MS,PHD

CONTACT

381440617; paulovsoares@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 14, 2017
• First Posted: March 20, 2017
• Study Start: March 14, 2017
• Primary Completion: June 1, 2017
• Study Completion: February 1, 2018
• Last Updated: March 20, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)