NCT03076944

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 10, 2017

Completed
10 days until next milestone

Study Start

First participant enrolled

March 20, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

March 29, 2017

Status Verified

March 1, 2017

Enrollment Period

8 months

First QC Date

March 7, 2017

Last Update Submit

March 27, 2017

Conditions

Hypersensitivity DentinDentin SensitivityDentin HypersensitivityDentine Hypersensitivity

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Neural agent

ACTIVE COMPARATOR

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

Drug: UltraEZ

Obliterator agent

ACTIVE COMPARATOR

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

Drug: Enamelast

Associative approach

ACTIVE COMPARATOR

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.)

Drug: UltraEZDrug: Enamelast

Interventions

UltraEZDRUG

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

Associative approachNeural agent
EnamelastDRUG

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

Associative approachObliterator agent

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Uberlândia

Uberlândia, Minas Gerais, 381440617, Brazil

RECRUITING

Related Publications (5)

  • 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.

    PMID: 7702459BACKGROUND

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

    PMID: 24724135BACKGROUND

  • 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.

    PMID: 12662460BACKGROUND

  • 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.

    PMID: 5218158BACKGROUND

  • 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.

    PMID: 22296690BACKGROUND

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

UltraEZ

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Paulo V Soares, DDS, MS, PHD

    Federal University of Uberlandia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paulo V Soares, DDS,MS,PHD

CONTACT

+55 34 991615642paulovsoares@yahoo.com.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 7, 2017

First Posted

March 10, 2017

Study Start

March 20, 2017

Primary Completion

November 1, 2017

Study Completion

March 1, 2018

Last Updated

March 29, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)