Clinical Evaluation of Different Potassium Oxalate Concentrations in Dentin Hypersensitivity Treatment

Not Applicable

• Conditions: Hypersensitivity Dentin; Dentine Hypersensitivity; Dentin Hypersensitivity; Dentin Sensitivity
• Interventions: Drug: Potassium Oxalate 5%; Drug: Potassium Oxalate 10%

• Registration Number: NCT03083496
• Lead Sponsor: Federal University of Uberlandia

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.

Detailed 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.

Study Timeline

• Status Verified: 2017-03
• Study Start: 2017-03-14
• Study First Submitted: 2017-03-14
• Study First Submitted QC: 2017-03-14
• Last Update Submitted: 2017-03-14
• Study First Posted: 2017-03-20
• Last Update Posted: 2017-03-20
• Primary Completion: 2017-06
• Study Completion: 2018-02

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
Potassium Oxalate 10%	Potassium Oxalate 5%	Prophylaxis of the teeth; an application every 48 hours; 4 sessions
Potassium Oxalate 5%	Potassium Oxalate 5%	Prophylaxis of the teeth; an application every 48 hours; 4 sessions
Potassium Oxalate 10%	Potassium Oxalate 10%	Prophylaxis of the teeth; an application every 48 hours; 4 sessions
Potassium Oxalate 5%	Potassium Oxalate 10%	Prophylaxis of the teeth; an application every 48 hours; 4 sessions

Primary Outcome Measures

Name	Time	Method
Level of cervical dentin hypersensitivity by using visual analog scale	3 weeks	Evaluation of the reduction in dentin hypersensitivity levels by using visual analog scale with a 3 weeks follow up.

Trial Locations

Locations (1)

Paulo V Soares; 🇧🇷 Uberlandia, Federal University of Uberlandia, Brazil