Ignite Creation Date:
2024-05-06 @ 2:50 AM
Last Modification Date:
2024-10-26 @ 11:24 AM
Study NCT ID:
NCT02136576
Status:
COMPLETED
Last Update Posted:
2020-12-10
First Post:
2014-05-07
Brief Title:
Caries Prevention Products Dentinal Hypersensitivity
Sponsor:
Tufts University
Organization:
Tufts University
Study Overview
Official Title:
Comparing Three Caries Prevention Products on Dentinal Hypersensitivity - A Pilot Study
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this pilot research project is to compare the clinical effect on dentinal hypersensitivity of three products Casein Phosphopeptide-Amorphous Calcium Phosphate CPP-ACP paste with fluoride 5000 Sodium Fluoride NaF dentifrice containing Tri-Calcium Phosphate TCP and a dentifrice containing Potassium Nitrate
The hypothesis of this study is that CPP-ACP with fluoride and 5000ppm NaF with TCP will exhibit a greater reduction in dentinal hypersensitivity compared to the control dentifrice containing Potassium Nitrate
The results of this pilot study will validate or negate the need for a larger clinical study that may provide generalizable results for using caries-prevention products with the additional benefit of minimizing dentinal hypersensitivity
The hypothesis of this study is that CPP-ACP with fluoride and 5000ppm NaF with TCP will exhibit a greater reduction in dentinal hypersensitivity compared to the control dentifrice containing Potassium Nitrate
The results of this pilot study will validate or negate the need for a larger clinical study that may provide generalizable results for using caries-prevention products with the additional benefit of minimizing dentinal hypersensitivity
Detailed Description:
Dentinal hypersensitivity commonly occurs in patients with gingival recession resulting from a reduced periodontium or in patients who have undergone non-surgical and surgical periodontal therapy Pradeep 2010 Yilmaz 2011 When the gingiva recede the root surfaces of the teeth are exposed West 2008 In addition after a non-surgical or surgical periodontal procedure the cementum of the root surface is removed as a result of scaling and root planing This leaves dentin exposed on the root surface with open dentinal tubules In addition dentin is less mineralized than enamel and has a greater susceptibility to and a faster progression of root caries and dentinal hypersensitivity Saunders 2005 Root caries commonly occurs in patients who have undergone periodontal therapy and extensive root caries often results in the extraction of the tooth Hull 1997
Dental professionals often make a variety of recommendations to remedy dental hypersensitivity including the application of fluoride varnishes anti-hypersensitivity toothpaste gingival grafting procedures and various restorative procedures aiming to occlude the dentinal tubules or desensitize the pulpal nerve endings Brahmbhatt 2012 Orsini 2010
Since the introduction of Caries Management By Risk Assessment CAMBRA in the Journal of the California Dental Association in 2007 Jenson 2007 Young 2007 the marketplace for anti-caries products has surged As a result many approaches to the management of dental caries have been introduced and dental practitioners and sales representatives have promoted several anti-caries products In addition the reduction or the abatement of the progression of dental caries coronal root and interproximal as a result of a caries management program has been reported Featherstone 1992 Ito 2012 Many caries management products have ingredients that include fluoride and calcium phosphate Amorphous Calcium Phosphate-Casein Phosphopeptide Recaldent Wang 2012 Tri-Calcium Phosphate or Novamin Su 2011 Moreover encouraging clinical findings have been reported including but not limited to the reduction of white spot enamel lesions and dentinal hypersensitivity Kowalczyk 2006
The topical application of antihypersensitivity materials is a common recommendation least invasive of the standard of care recommendations to diminish dentinal hypersensitivity and will serve to provide data for the research study The study will evaluate which of these products result in the greatest reduction of dentinal hypersensitivity The application of the experimental products for the reduction of dentinal hypersensitivity is for research purposes
The methods used to test sensitivity in this study have been used in published studies Brahmbhatt 2012 Holland 1997 The VAS scale used in this study has also been used for tooth sensitivity studies Holland 1997 Hughes 2010 A 30 decrease in VAS score has been shown to be clinically meaningful Ritter 2006 Raymond 2008
This pilot study would investigate the ability of anti-caries products to reduce dentinal hypersensitivity when compared to a sensitivity-reducing dentifrice It would be a novel contribution to the dental community if a material that is proven to reduce tooth decay is also proven to reduce dentinal hypersensitivity The results may potentially have a tremendous impact on the dental community because it may provide dental professionals a scientifically-supported approach to improve the comfort and quality of life of periodontal patients patients who are treated for gum disease bone loss around teeth and increase the lifespan of teeth that undergo periodontal treatment
Dental professionals often make a variety of recommendations to remedy dental hypersensitivity including the application of fluoride varnishes anti-hypersensitivity toothpaste gingival grafting procedures and various restorative procedures aiming to occlude the dentinal tubules or desensitize the pulpal nerve endings Brahmbhatt 2012 Orsini 2010
Since the introduction of Caries Management By Risk Assessment CAMBRA in the Journal of the California Dental Association in 2007 Jenson 2007 Young 2007 the marketplace for anti-caries products has surged As a result many approaches to the management of dental caries have been introduced and dental practitioners and sales representatives have promoted several anti-caries products In addition the reduction or the abatement of the progression of dental caries coronal root and interproximal as a result of a caries management program has been reported Featherstone 1992 Ito 2012 Many caries management products have ingredients that include fluoride and calcium phosphate Amorphous Calcium Phosphate-Casein Phosphopeptide Recaldent Wang 2012 Tri-Calcium Phosphate or Novamin Su 2011 Moreover encouraging clinical findings have been reported including but not limited to the reduction of white spot enamel lesions and dentinal hypersensitivity Kowalczyk 2006
The topical application of antihypersensitivity materials is a common recommendation least invasive of the standard of care recommendations to diminish dentinal hypersensitivity and will serve to provide data for the research study The study will evaluate which of these products result in the greatest reduction of dentinal hypersensitivity The application of the experimental products for the reduction of dentinal hypersensitivity is for research purposes
The methods used to test sensitivity in this study have been used in published studies Brahmbhatt 2012 Holland 1997 The VAS scale used in this study has also been used for tooth sensitivity studies Holland 1997 Hughes 2010 A 30 decrease in VAS score has been shown to be clinically meaningful Ritter 2006 Raymond 2008
This pilot study would investigate the ability of anti-caries products to reduce dentinal hypersensitivity when compared to a sensitivity-reducing dentifrice It would be a novel contribution to the dental community if a material that is proven to reduce tooth decay is also proven to reduce dentinal hypersensitivity The results may potentially have a tremendous impact on the dental community because it may provide dental professionals a scientifically-supported approach to improve the comfort and quality of life of periodontal patients patients who are treated for gum disease bone loss around teeth and increase the lifespan of teeth that undergo periodontal treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| New Investigator Grant | OTHER | TUSDM | None |