NCT02018783

Brief Summary

The aim of this study was to evaluate the efficacy of three desensitizing toothpastes for immediate and intermediate-term relief of CDH, when compared with a control toothpaste. One hundred and thirty-eight hypersensitive teeth were diagnosed and randomized into four groups according to the therapeutic agent of each desensitizing cream tested: 1) strontium acetate and calcium carbonate, 2) calcium carbonate and arginine 8%, 3) calcium phosphate nanoparticles and 4) a control toothpaste. The desensitizing creams were applied according to the manufacturer's instructions. Cervical dentin hypersensitivity was assessed at baseline, immediately, 24 hours and 30 days after the treatment. Cold and evaporative tests were used to assess the sensitivity level.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
138

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 23, 2013

Completed
Last Updated

December 23, 2013

Status Verified

December 1, 2013

Enrollment Period

4 months

First QC Date

December 7, 2013

Last Update Submit

December 17, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • cervical dentin hypersensitivity

    The cervical dentin hypersensitivity was evaluated by an air blast (evaporative stimulus) for 5 seconds, and by a tetrafluoroethane spray (cold stimulus) for 5 seconds.

    30 days

Study Arms (4)

Sensodyne

EXPERIMENTAL

Digital application for 60 seconds.

Procedure: Sensodyne

Colgate

EXPERIMENTAL

Slow-speed handpiece with a Robson brush for 3 seconds by repeating the procedure

Procedure: Colgate

Nano P

EXPERIMENTAL

Slow-speed handpiece with a Robson brush for 10 seconds

Procedure: Nano P

Cocorico

PLACEBO COMPARATOR

Digital application for 60 seconds

Procedure: Cocorico

Interventions

ColgatePROCEDURE

Slow-speed handpiece with a Robson brush for 3 seconds by repeating the procedure

Colgate
SensodynePROCEDURE

Digital application for 60 seconds.

Sensodyne
Nano PPROCEDURE

Slow-speed handpiece with a Robson brush for 10 seconds

Nano P
CocoricoPROCEDURE

Digital application for 60 seconds

Cocorico

Eligibility Criteria

Age22 Years - 48 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • subjects 18 years or older
  • in good general and oral health; have complaint of CDH in teeth distributed in all 4 quadrants
  • not making use of desensitizing agents
  • not having undergone periodontal treatment over the past 3 months
  • respond to evaporative stimulus with a score ≥ 1.5 cm on VAS

You may not qualify if:

  • patients who presented restorations and caries near the exposed dentin of the hypersensitive teeth
  • who made frequent use of painkillers, anti-inflammatory and antidepressants drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Periodontics Clinic, Department of Dentistry

Diamantina, Minas Gerais, 39100000, Brazil

Location

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

Sodium FluorideSensodyne

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

FluoridesHydrofluoric AcidFluorine CompoundsInorganic ChemicalsSodium CompoundsCariostatic AgentsBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Olga D Flecha, PhD

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

December 7, 2013

First Posted

December 23, 2013

Study Start

April 1, 2013

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

December 23, 2013

Record last verified: 2013-12

Locations