Assessment of Different Protocols for Cervical Dentin Hypersensitivity Treatment

NCT ID: NCT02931734

Last Updated: 2016-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-07-31

Brief Summary

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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

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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.

Conditions

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Hypersensitivity Dentin Dentin Sensitivity Dentin Hypersensitivity Dentine Hypersensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Resin modified glass ionomer (RMGI)

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

Group Type ACTIVE_COMPARATOR

Resin modified glass ionomer

Intervention Type DRUG

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

Potassium Nitrate 2% (KF)

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

Group Type ACTIVE_COMPARATOR

Potassium Nitrate 2%

Intervention Type DRUG

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

Low level laser therapy - GaAlAs (LLLT)

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

Group Type ACTIVE_COMPARATOR

Low level laser therapy

Intervention Type PROCEDURE

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.

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.

Group Type ACTIVE_COMPARATOR

Resin modified glass ionomer

Intervention Type DRUG

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

Potassium Nitrate 2%

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Resin modified glass ionomer

Intervention Type DRUG

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

Low level laser therapy

Intervention Type PROCEDURE

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.

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.

Group Type ACTIVE_COMPARATOR

Potassium Nitrate 2%

Intervention Type DRUG

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

Low level laser therapy

Intervention Type PROCEDURE

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.

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.

Group Type ACTIVE_COMPARATOR

Resin modified glass ionomer

Intervention Type DRUG

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

Potassium Nitrate 2%

Intervention Type DRUG

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

Low level laser therapy

Intervention Type PROCEDURE

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.

Interventions

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Resin modified glass ionomer

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

Intervention Type DRUG

Potassium Nitrate 2%

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

Intervention Type DRUG

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.

Intervention Type PROCEDURE

Other Intervention Names

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Clinpro Desensibilize KF Photon Lase III

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of Uberlandia

OTHER

Sponsor Role lead

Responsible Party

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PAULO VINICIUS SOARES

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paulo V Soares, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Uberlandia

Locations

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Federal University of Uberlandia

Uberlândia, Minas Gerais, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 7702459 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16687880 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 24724135 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12662460 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 11203968 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 5218158 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22296690 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 23268573 (View on PubMed)

Other Identifiers

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CAAE:35634614.2.0000.5152

Identifier Type: -

Identifier Source: org_study_id

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