Evaluation of Desensitization Protocols in Reduction of Dentin Hypersensitivity

Dentin Sensitivity Clinical Trial

Official title:

Evaluation of Desensitization Protocols in Reduction of Dentin Hypersensitivity: A Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03076944
• Other study ID #: CAAE:60751416.1.0000.5152
• Status: Recruiting
• Phase: N/A
• First received: March 7, 2017
• Last updated: March 27, 2017
• Start date: March 20, 2017
• Est. completion date: March 2018

Study information

• Verified date: March 2017
• Source: Federal University of Uberlandia
• Contact: Paulo V Soares, DDS,MS,PHD
• Phone: +55 34 991615642
• Email: paulovsoares[@]yahoo.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is through a double blind randomized clinical trial, evaluate the effectiveness of different clinical protocols in the reduction of dentin hypersensitivity. The desensitization approach (single agent or associated agents) and the long-term effectiveness (baseline, 1 week, 2 weeks, 4 weeks, 12 weeks and 24 weeks) will be evaluated. Data will be collected, tabulated and submitted to statistical analysis.

Description:

Dentin hypersensitivity is characterized as an acute and short-term pain with multifactorial etiology. This condition is a clinical challenge due to the different treatment protocols available. Therefore, the aim of this study is through a double blind randomized clinical trial, evaluate the effectiveness of different clinical protocols in the reduction of dentin hypersensitivity. Thirty-two patients with dentin hypersensitivity in at least three teeth will be selected.The teeth will be randomly divided into two different groups according to the desensitization approach (single agent with neural action; single agent with obliterating action; associated technique (neural and obliterator agents). The dentin hypersensitivity level will be evaluated immediately after desensitization and after 1, 2, 4,12 and 24 weeks. Data will be collected, tabulated and submitted to statistical analysis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: March 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 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:
• UltraEZ
Prophylaxis, apply uniformly on the teeth, wait 15 minutes, remove the gel from the teeth with cotton and abundant water.
• Enamelast
Prophylaxis; dry the teeth; apply uniformly on the teeth with a thin layer.

Locations

Country	Name	City	State
Brazil	Federal University of Uberlândia	Uberlândia	Minas Gerais

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

Davari A, Ataei E, Assarzadeh H. Dentin hypersensitivity: etiology, diagnosis and treatment; a literature review. J Dent (Shiraz). 2013 Sep;14(3):136-45. Review. — 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

Orchardson R, Gangarosa LP Sr, Holland GR, Pashley DH, Trowbridge HO, Ashley FP, Kleinberg I, Zappa U. Dentine hypersensitivity-into the 21st century. Arch Oral Biol. 1994;39 Suppl:113S-119S. — 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 24 weeks follow up.	24 weeks