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

Primary Purpose

Hypersensitivity Dentin, Dentin Sensitivity, Dentin Hypersensitivity

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Resin modified glass ionomer

Potassium Nitrate 2%

Low level laser therapy

About this trial

This is an interventional treatment trial for Hypersensitivity Dentin

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Federal University of Uberlandia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Active Comparator

Arm Label

Resin modified glass ionomer (RMGI)

Potassium Nitrate 2% (KF)

Low level laser therapy - GaAlAs (LLLT)

RMGI and KF

RMGI and LLLT

KF and LLLT

RMGI, KF, LLLT

Arm Description

Resin modified glass ionomer; an application every 48 hours; 4 sessions.

Potassium Nitrate and Sodium fluoride 2%; an application every 48 hours; 4 sessions.

Low level laser therapy - GaAlAs; an application every 48 hours; 4 sessions.

Resin modified glass ionomer and potassium nitrate and sodium fluoride 2%; an application of the two associated products, every 48 hours; 4 sessions.

Resin modified glass ionomer and Low level laser therapy - GaAlAs; an application of the two associated products, every 48 hours; 4 sessions.

Potassium Nitrate and Sodium fluoride 2% and Low level laser therapy - GaAlAs; an application of the two associated products, every 48 hours; 4 sessions.

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.

Outcomes

Primary Outcome Measures

Level of cervical dentin hypersensitivity, measured by visual analog scale

Evaluate the reduction in Cervical Dentin Hypersensitivity with a 24 weeks follow up.

Secondary Outcome Measures

Full Information

NCT ID

NCT02931734

First Posted

October 3, 2016

Last Updated

October 13, 2016

Sponsor

Federal University of Uberlandia

1. Study Identification

Unique Protocol Identification Number

NCT02931734

Brief Title

Assessment of Different Protocols for Cervical Dentin Hypersensitivity Treatment

Acronym

CDH

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

October 2014 (undefined)

Primary Completion Date

January 2015 (Actual)

Study Completion Date

July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Federal University of Uberlandia

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypersensitivity Dentin, Dentin Sensitivity, Dentin Hypersensitivity, Dentine Hypersensitivity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

140 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Resin modified glass ionomer (RMGI)

Arm Type

Active Comparator

Arm Description

Resin modified glass ionomer; an application every 48 hours; 4 sessions.

Arm Title

Potassium Nitrate 2% (KF)

Arm Type

Active Comparator

Arm Description

Potassium Nitrate and Sodium fluoride 2%; an application every 48 hours; 4 sessions.

Arm Title

Low level laser therapy - GaAlAs (LLLT)

Arm Type

Active Comparator

Arm Description

Low level laser therapy - GaAlAs; an application every 48 hours; 4 sessions.

Arm Title

RMGI and KF

Arm Type

Active Comparator

Arm Description

Resin modified glass ionomer and potassium nitrate and sodium fluoride 2%; an application of the two associated products, every 48 hours; 4 sessions.

Arm Title

RMGI and LLLT

Arm Type

Active Comparator

Arm Description

Resin modified glass ionomer and Low level laser therapy - GaAlAs; an application of the two associated products, every 48 hours; 4 sessions.

Arm Title

KF and LLLT

Arm Type

Active Comparator

Arm Description

Potassium Nitrate and Sodium fluoride 2% and Low level laser therapy - GaAlAs; an application of the two associated products, every 48 hours; 4 sessions.

Arm Title

RMGI, KF, LLLT

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Resin modified glass ionomer

Other Intervention Name(s)

Clinpro

Intervention Description

Prophylaxis, washing and removing water excess , apply the Clinpro forming a uniform layer of 0.5mm, lightcure for 20 seconds

Intervention Type

Drug

Intervention Name(s)

Potassium Nitrate 2%

Other Intervention Name(s)

Desensibilize KF

Intervention Description

Prophylaxis, apply uniformly on the teeth, wait 10 minutes, remove the gel from the teeth with cotton and abundant water.

Intervention Type

Procedure

Intervention Name(s)

Low level laser therapy

Other Intervention Name(s)

Photon Lase III

Intervention Description

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.

Primary Outcome Measure Information:

Title

Level of cervical dentin hypersensitivity, measured by visual analog scale

Description

Evaluate the reduction in Cervical Dentin Hypersensitivity with a 24 weeks follow up.

Time Frame

24 weeks

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paulo V Soares, PhD

Organizational Affiliation

Federal University of Uberlandia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Federal University of Uberlandia

City

Uberlandia

State/Province

Minas Gerais

ZIP/Postal Code

38400-000

Country

Brazil

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

7702459

Citation

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.

Results Reference

background

PubMed Identifier

16687880

Citation

Lussi A. Erosive tooth wear - a multifactorial condition of growing concern and increasing knowledge. Monogr Oral Sci. 2006;20:1-8. doi: 10.1159/000093343.

Results Reference

background

PubMed Identifier

24724135

Citation

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

Results Reference

background

PubMed Identifier

12662460

Citation

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.

Results Reference

background

PubMed Identifier

11203968

Citation

Coleman TA, Grippo JO, Kinderknecht KE. Cervical dentin hypersensitivity. Part II: Associations with abfractive lesions. Quintessence Int. 2000 Jul-Aug;31(7):466-73.

Results Reference

background

PubMed Identifier

5218158

Citation

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.

Results Reference

background

PubMed Identifier

22296690

Citation

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.

Results Reference

background

PubMed Identifier

23268573

Citation

Grippo JO. Biocorrosion vs. erosion: the 21st century and a time to change. Compend Contin Educ Dent. 2012 Feb;33(2):e33-7.

Results Reference

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Assessment of Different Protocols for Cervical Dentin Hypersensitivity Treatment

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