Evaluation of Desensitization Protocols in Reduction of Dentin Hypersensitivity

Not Applicable

• Conditions: Dentin Hypersensitivity; Hypersensitivity Dentin; Dentin Sensitivity; Dentine Hypersensitivity
• Interventions: Drug: UltraEZ; Drug: Enamelast

• Registration Number: NCT03076944
• Lead Sponsor: Federal University of Uberlandia

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.

Study Timeline

• Status Verified: 2017-03
• Study First Submitted: 2017-03-07
• Study First Submitted QC: 2017-03-09
• Study First Posted: 2017-03-10
• Study Start: 2017-03-20
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-29
• Primary Completion: 2017-11
• Study Completion: 2018-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neural agent	UltraEZ	UltraEZ. Prophylaxis of the teeth; an application every 48 hours; 4 sessions
Obliterator agent	Enamelast	Enamelast. Prophylaxis of the teeth; an application every 48 hours; 4 sessions
Associative approach	Enamelast	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.)
Associative approach	UltraEZ	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.)

Primary Outcome Measures

Name	Time	Method
Level of cervical dentin hypersensitivity by using visual analog scale	24 weeks	Evaluation of the reduction in dentin hypersensitivity levels by using visual analog scale with a 24 weeks follow up.

Trial Locations

Locations (1)

Federal University of Uberlândia; 🇧🇷 Uberlândia, Minas Gerais, Brazil