NCT02931734

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 13, 2016

Completed
Last Updated

October 14, 2016

Status Verified

October 1, 2016

Enrollment Period

3 months

First QC Date

October 3, 2016

Last Update Submit

October 13, 2016

Conditions

Hypersensitivity DentinDentin SensitivityDentin HypersensitivityDentine Hypersensitivity

Outcome Measures

Primary Outcomes (1)

  • Level of cervical dentin hypersensitivity, measured by visual analog scale

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

    24 weeks

Study Arms (7)

Resin modified glass ionomer (RMGI)

ACTIVE COMPARATOR

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

Drug: Resin modified glass ionomer

Potassium Nitrate 2% (KF)

ACTIVE COMPARATOR

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

Drug: Potassium Nitrate 2%

Low level laser therapy - GaAlAs (LLLT)

ACTIVE COMPARATOR

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

Procedure: Low level laser therapy

RMGI and KF

ACTIVE COMPARATOR

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 ionomerDrug: Potassium Nitrate 2%

RMGI and LLLT

ACTIVE COMPARATOR

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 ionomerProcedure: Low level laser therapy

KF and LLLT

ACTIVE COMPARATOR

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%Procedure: Low level laser therapy

RMGI, KF, LLLT

ACTIVE COMPARATOR

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 ionomerDrug: Potassium Nitrate 2%Procedure: Low level laser therapy

Interventions

Resin modified glass ionomerDRUG

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

Also known as: Clinpro
RMGI and KFRMGI and LLLTRMGI, KF, LLLTResin modified glass ionomer (RMGI)
Potassium Nitrate 2%DRUG

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

Also known as: Desensibilize KF
KF and LLLTPotassium Nitrate 2% (KF)RMGI and KFRMGI, KF, LLLT
Low level laser therapyPROCEDURE

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.

Also known as: Photon Lase III
KF and LLLTLow level laser therapy - GaAlAs (LLLT)RMGI and LLLTRMGI, KF, LLLT

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Uberlandia

Uberlândia, Minas Gerais, 38400-000, Brazil

Location

Related Publications (8)

  • 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.

    PMID: 7702459BACKGROUND

  • 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.

    PMID: 16687880BACKGROUND

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

    PMID: 24724135BACKGROUND

  • 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.

    PMID: 12662460BACKGROUND

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

    PMID: 11203968BACKGROUND

  • 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.

    PMID: 5218158BACKGROUND

  • 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.

    PMID: 22296690BACKGROUND

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

    PMID: 23268573BACKGROUND

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

Clinpro SealantLow-Level Light Therapy

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Officials

  • Paulo V Soares, PhD

    Federal University of Uberlandia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 3, 2016

First Posted

October 13, 2016

Study Start

October 1, 2014

Primary Completion

January 1, 2015

Study Completion

July 1, 2015

Last Updated

October 14, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)