Clinical Evaluation of Different Potassium Oxalate Concentrations in Dentin Hypersensitivity Treatment

Dentin Sensitivity Clinical Trial

Official title:

Clinical Evaluation of Different Potassium Oxalate Concentrations in Dentin: A Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03083496
• Other study ID #: 61102016.0.0000.5152
• Status: Recruiting
• Phase: N/A
• First received: March 14, 2017
• Last updated: March 14, 2017
• Start date: March 14, 2017
• Est. completion date: February 2018

Study information

• Verified date: March 2017
• Source: Federal University of Uberlandia
• Contact: Paulo V Soares, DDS,MS,PHD
• Phone: 381440617
• Email: paulovsoares[@]yahoo.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). Data will be collected, tabulated and submitted to statistical analysis.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: February 2018
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Dentin Hypersensitivity
• Dentin Sensitivity
• Dentine Hypersensitivity
• Hypersensitivity
• Hypersensitivity Dentin

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Paulo V Soares	Uberlandia	Federal University of Uberlandia

Sponsors (3)

Lead Sponsor	Collaborator
Federal University of Uberlandia	Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Fundação de Amparo à Pesquisa do estado de Minas Gerais

Country where clinical trial is conducted

Brazil, 

References & Publications (5)

Brännström M. Sensitivity of dentine. Oral Surg Oral Med Oral Pathol. 1966 Apr;21(4):517-26. — View 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. Review. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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