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Trial record 31 of 32 for:    FLUORIDE ION AND NITRATE ION

Assessment of Different Protocols for Cervical Dentin Hypersensitivity Treatment (CDH)

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ClinicalTrials.gov Identifier: NCT02931734
Recruitment Status : Completed
First Posted : October 13, 2016
Last Update Posted : October 14, 2016
Sponsor:
Information provided by (Responsible Party):
PAULO VINICIUS SOARES, Federal University of Uberlandia

Brief Summary:
The aim of this study is through a randomized clinical trial, double blind, splith-mouth, evaluate the various types of protocols and clinical efficacy in the reduction or even elimination of dentinal hypersensitivity by the agents Desensibilize KF - FGM Dental Products, Clinpro - 3M Company, Minnesota - USA, Photon Laser III - DMC, Brazil, Desensibilize KF and laser, Desensibilize KF and Clinpro, laser and Clinpro and the association of all products. Data will be collected, tabulated and submitted to statistical analysis.

Condition or disease Intervention/treatment Phase
Hypersensitivity Dentin Dentin Sensitivity Dentin Hypersensitivity Dentine Hypersensitivity Drug: Resin modified glass ionomer Drug: Potassium Nitrate 2% Procedure: Low level laser therapy Not Applicable

Detailed Description:
Cervical dentin hypersensitivity is a painful condition and is a clinical challenge due to different treatment strategies available. The aim of this study is through a randomized clinical trial, double blind, splith-mouth, evaluate the various types of protocols and clinical efficacy in the reduction or even elimination of dentinal hypersensitivity. A hundred forty teeth of healthy patients of both sexes were selected. Visual Analog Scale was used pain (VAS) to measure the intensity of the patient's pain. The teeth will be randomly divided into 7 different groups according to the desensitization treatment under study: Desensibilize KF - FGM Dental Products, Clinpro - 3M Company, Minnesota - USA, Photon Laser III - DMC, Brazil, Desensibilize KF and laser, Desensibilize KF and Clinpro, laser and Clinpro and the association of all products. Data will be collected, tabulated and submitted to statistical analysis.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Analysis of the Association of Products for the Treatment of Cervical Dentin Hypersensitivity
Study Start Date : October 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Active Comparator: Resin modified glass ionomer (RMGI)
Resin modified glass ionomer; an application every 48 hours; 4 sessions.
Drug: Resin modified glass ionomer
Prophylaxis, washing and removing water excess , apply the Clinpro forming a uniform layer of 0.5mm, lightcure for 20 seconds
Other Name: Clinpro

Active Comparator: Potassium Nitrate 2% (KF)
Potassium Nitrate and Sodium fluoride 2%; an application every 48 hours; 4 sessions.
Drug: Potassium Nitrate 2%
Prophylaxis, apply uniformly on the teeth, wait 10 minutes, remove the gel from the teeth with cotton and abundant water.
Other Name: Desensibilize KF

Active Comparator: Low level laser therapy - GaAlAs (LLLT)
Low level laser therapy - GaAlAs; an application every 48 hours; 4 sessions.
Procedure: Low level laser therapy
Prophylaxis, applying infrared laser at low power in points: mesial, buccal, distal and in the apical point in the foyer of fornix with power of 110MW for 11 seconds at each point.
Other Name: Photon Lase III

Active Comparator: RMGI and KF
Resin modified glass ionomer and potassium nitrate and sodium fluoride 2%; an application of the two associated products, every 48 hours; 4 sessions.
Drug: Resin modified glass ionomer
Prophylaxis, washing and removing water excess , apply the Clinpro forming a uniform layer of 0.5mm, lightcure for 20 seconds
Other Name: Clinpro

Drug: Potassium Nitrate 2%
Prophylaxis, apply uniformly on the teeth, wait 10 minutes, remove the gel from the teeth with cotton and abundant water.
Other Name: Desensibilize KF

Active Comparator: RMGI and LLLT
Resin modified glass ionomer and Low level laser therapy - GaAlAs; an application of the two associated products, every 48 hours; 4 sessions.
Drug: Resin modified glass ionomer
Prophylaxis, washing and removing water excess , apply the Clinpro forming a uniform layer of 0.5mm, lightcure for 20 seconds
Other Name: Clinpro

Procedure: Low level laser therapy
Prophylaxis, applying infrared laser at low power in points: mesial, buccal, distal and in the apical point in the foyer of fornix with power of 110MW for 11 seconds at each point.
Other Name: Photon Lase III

Active Comparator: KF and LLLT
Potassium Nitrate and Sodium fluoride 2% and Low level laser therapy - GaAlAs; an application of the two associated products, every 48 hours; 4 sessions.
Drug: Potassium Nitrate 2%
Prophylaxis, apply uniformly on the teeth, wait 10 minutes, remove the gel from the teeth with cotton and abundant water.
Other Name: Desensibilize KF

Procedure: Low level laser therapy
Prophylaxis, applying infrared laser at low power in points: mesial, buccal, distal and in the apical point in the foyer of fornix with power of 110MW for 11 seconds at each point.
Other Name: Photon Lase III

Active Comparator: RMGI, KF, LLLT
Resin modified glass ionomer, potassium nitrate and sodium fluoride 2% and Low level laser therapy - GaAlAs ; an application of the three associated products, every 48 hours; 4 sessions.
Drug: Resin modified glass ionomer
Prophylaxis, washing and removing water excess , apply the Clinpro forming a uniform layer of 0.5mm, lightcure for 20 seconds
Other Name: Clinpro

Drug: Potassium Nitrate 2%
Prophylaxis, apply uniformly on the teeth, wait 10 minutes, remove the gel from the teeth with cotton and abundant water.
Other Name: Desensibilize KF

Procedure: Low level laser therapy
Prophylaxis, applying infrared laser at low power in points: mesial, buccal, distal and in the apical point in the foyer of fornix with power of 110MW for 11 seconds at each point.
Other Name: Photon Lase III




Primary Outcome Measures :
  1. Level of cervical dentin hypersensitivity, measured by visual analog scale [ Time Frame: 24 weeks ]
    Evaluate the reduction in Cervical Dentin Hypersensitivity with a 24 weeks follow up.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • presence of dentin exposure lesions with clinical diagnosis of moderate or severe tooth sensitivity
  • good oral hygiene.

Exclusion Criteria:

  • cavities,
  • presence of periodontal disease and or parafunctional habits,
  • cracks or enamel fractures,
  • extensive or unsatisfactory restorations,
  • recent restorations involving the labial surface,
  • dentures,
  • orthodontics.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02931734


Locations
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Brazil
Federal University of Uberlandia
Uberlandia, Minas Gerais, Brazil, 38400-000
Sponsors and Collaborators
Federal University of Uberlandia
Investigators
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Principal Investigator: Paulo V Soares, PhD Federal University of Uberlandia

Publications:
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Responsible Party: PAULO VINICIUS SOARES, Professor, Federal University of Uberlandia
ClinicalTrials.gov Identifier: NCT02931734     History of Changes
Other Study ID Numbers: CAAE:35634614.2.0000.5152
First Posted: October 13, 2016    Key Record Dates
Last Update Posted: October 14, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Dentin Sensitivity
Hypersensitivity
Immune System Diseases
Tooth Diseases
Stomatognathic Diseases
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors