Single Application of Desensitizing Pastes as Dentin Sensitivity Treatment
Clinical Evaluation of the Effectiveness of Immediate Relief Obtained With Desensitizing Creams - A Controlled, Randomized, Triple Masked, Split-Mouth Clinical Trial
1 other identifier
interventional
138
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2013
Shorter than P25 for not_applicable
1 active site
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 7, 2013
CompletedFirst Posted
Study publicly available on registry
December 23, 2013
CompletedDecember 23, 2013
December 1, 2013
4 months
December 7, 2013
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
EXPERIMENTALDigital application for 60 seconds.
Colgate
EXPERIMENTALSlow-speed handpiece with a Robson brush for 3 seconds by repeating the procedure
Nano P
EXPERIMENTALSlow-speed handpiece with a Robson brush for 10 seconds
Cocorico
PLACEBO COMPARATORDigital application for 60 seconds
Interventions
Slow-speed handpiece with a Robson brush for 3 seconds by repeating the procedure
Eligibility Criteria
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Olga D Flecha, PhD
Federal University of São Paulo
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