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

October 13, 2016 updated by: PAULO VINICIUS SOARES, Federal University of Uberlandia

Analysis of the Association of Products for the Treatment of Cervical Dentin Hypersensitivity

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Minas Gerais
      • Uberlandia, Minas Gerais, Brazil, 38400-000
        • Federal University of Uberlândia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • Photon Lase III

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Uberlandia

Investigators

  • Principal Investigator: Paulo V Soares, PhD, Federal University of Uberlândia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

October 3, 2016

First Submitted That Met QC Criteria

October 12, 2016

First Posted (Estimate)

October 13, 2016

Study Record Updates

Last Update Posted (Estimate)

October 14, 2016

Last Update Submitted That Met QC Criteria

October 13, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAAE:35634614.2.0000.5152

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dentin Sensitivity

Clinical Trials on Resin modified glass ionomer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Norway

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe