Evaluation of Desensitization Protocols in Reduction of Dentin Hypersensitivity

NCT ID: NCT03076944

Last Updated: 2017-03-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-20
• Study Completion Date: 2018-03-31

Brief 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.

Detailed 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.

Conditions

Hypersensitivity Dentin; Dentin Sensitivity; Dentin Hypersensitivity; Dentine Hypersensitivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Neural agent

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

Group Type: ACTIVE_COMPARATOR

UltraEZ

Intervention Type: DRUG

Prophylaxis, apply uniformly on the teeth, wait 15 minutes, remove the gel from the teeth with cotton and abundant water.

Obliterator agent

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

Group Type: ACTIVE_COMPARATOR

Enamelast

Intervention Type: DRUG

Prophylaxis; dry the teeth; apply uniformly on the teeth with a thin layer.

Associative approach

UltraEZ and Enamelast. Prophylaxis of the teeth; an application every 48 hours; 4 sessions. In each session, fistly the UltraEZ (neural agent) will be applied and after the Enamelast (obliterator agent.)

Group Type: ACTIVE_COMPARATOR

UltraEZ

Intervention Type: DRUG

Prophylaxis, apply uniformly on the teeth, wait 15 minutes, remove the gel from the teeth with cotton and abundant water.

Enamelast

Intervention Type: DRUG

Prophylaxis; dry the teeth; apply uniformly on the teeth with a thin layer.

Interventions

UltraEZ

Prophylaxis, apply uniformly on the teeth, wait 15 minutes, remove the gel from the teeth with cotton and abundant water.

Intervention Type: DRUG

Enamelast

Prophylaxis; dry the teeth; apply uniformly on the teeth with a thin layer.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

Sponsor Role: collaborator

Fundação de Amparo à Pesquisa do estado de Minas Gerais

OTHER

Sponsor Role: collaborator

Federal University of Uberlandia

OTHER

Sponsor Role: lead

Responsible Party

PAULO VINICIUS SOARES

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paulo V Soares, DDS, MS, PHD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Uberlandia

Locations

Federal University of Uberlândia

Uberlândia, Minas Gerais, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Paulo V Soares, DDS,MS,PHD

Role: CONTACT

paulovsoares@yahoo.com.br

+55 34 991615642

Facility Contacts

Paulo V Soares, DDS,MS,PHD

Role: primary

paulovsoares@yahoo.com.br

+55 34 991615642

References

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. doi: 10.1016/0003-9969(94)90197-x. No abstract available.

Reference Type: BACKGROUND

PMID: 7702459 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 24724135 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12662460 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 5218158 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22296690 (View on PubMed)

Other Identifiers

CAAE:60751416.1.0000.5152

Identifier Type: -

Identifier Source: org_study_id