Assessment of Different Protocols for Cervical Dentin Hypersensitivity Treatment

Dentin Sensitivity Clinical Trial

— CDH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02931734
• Other study ID #: CAAE:35634614.2.0000.5152
• Status: Completed
• Phase: N/A
• First received: October 3, 2016
• Last updated: October 13, 2016
• Start date: October 2014
• Est. completion date: July 2015

Study information

• Verified date: October 2016
• Source: Federal University of Uberlandia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: July 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dentin Hypersensitivity
• Dentin Sensitivity
• Dentine Hypersensitivity
• Hypersensitivity
• Hypersensitivity Dentin

Intervention

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
• Potassium Nitrate 2%
Prophylaxis, apply uniformly on the teeth, wait 10 minutes, remove the gel from the teeth with cotton and abundant water.

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.

Locations

Country	Name	City	State
Brazil	Federal University of Uberlandia	Uberlandia	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Uberlandia

Country where clinical trial is conducted

Brazil, 

References & Publications (8)

Brännström M. Sensitivity of dentine. Oral Surg Oral Med Oral Pathol. 1966 Apr;21(4):517-26. — View 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. Review. — View 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. — View 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. Review. — View 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. Review. — View Citation

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

Lussi A. Erosive tooth wear - a multifactorial condition of growing concern and increasing knowledge. Monogr Oral Sci. 2006;20:1-8. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes