Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| New Investigator Grant | Other Identifier | TUSDM |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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 â„¢), (Wang 2012) Tri-Calcium Phosphate â„¢ or Novamin â„¢) (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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sensodyne | Active Comparator | There are no specific characteristics for inclusion in this group. Enrollment will be determined randomly. |
|
| Crest Cavity Protection & MI Paste Plus | Active Comparator | There are no specific characteristics for inclusion in this group. Enrollment will be determined randomly. |
|
| Clinpro 5000 | Active Comparator | There are no specific characteristics for inclusion in this group. Enrollment will be determined randomly. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sensodyne | Device | Subjects will be instructed to brush with Sensodyne twice daily (2 minutes each time in the morning and the evening) during the duration of the study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dentinal Hypersensitivity | The primary analysis will be to compare the dentinal hypersensitivity between the 3 groups. Air test: A 1 second blast of air from the air-water syringe was applied to the tooth. Water test: Three drops of ice water were be placed on the tooth. Schiff Score Investigator observed participant reaction to test and scored on following scale: 0-Tooth/Subject does not respond to stimulus.
VAS (visual analog scale): The participant reported sensitivity on a scale of 0-10. 0 being no pain and 10 being worst pain imaginable. | 8 weeks after baseline |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Britta Magnuson, DMD | Tufts University School of Dental Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts University School of Dental Medicine | Boston | Massachusetts | 02111 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20370417 | Background | Pradeep AR, Sharma A. Comparison of clinical efficacy of a dentifrice containing calcium sodium phosphosilicate to a dentifrice containing potassium nitrate and to a placebo on dentinal hypersensitivity: a randomized clinical trial. J Periodontol. 2010 Aug;81(8):1167-73. doi: 10.1902/jop.2010.100056. | |
| 21668343 | Background |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Sensodyne | There are no specific characteristics for inclusion in this group. Enrollment will be determined randomly. Sensodyne: Subjects will be instructed to brush with Sensodyne twice daily (2 minutes each time in the morning and the evening) during the duration of the study. |
| FG001 | Crest Cavity Protection & MI Paste Plus | There are no specific characteristics for inclusion in this group. Enrollment will be determined randomly. Crest Cavity Protection & MI Paste Plus: Subjects will be instructed to brush twice daily (2 minutes each time in the morning and the evening) using Crest Cavity Protection toothpaste. They will be instructed to apply MI Paste Plus (CPP-ACP with fluoride) twice daily to the study teeth after brushing their teeth. MI Paste Plus will be applied to the study teeth with a finger. |
| FG002 | Clinpro 5000 | There are no specific characteristics for inclusion in this group. Enrollment will be determined randomly. Clinpro 5000: Subjects will be instructed to brush with Clinpro 5000 twice daily (2 minutes each time in the morning and the evening) during duration of the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sensodyne | There are no specific characteristics for inclusion in this group. Enrollment will be determined randomly. Sensodyne: Subjects will be instructed to brush with Sensodyne twice daily (2 minutes each time in the morning and the evening) during the duration of the study. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Dentinal Hypersensitivity | The primary analysis will be to compare the dentinal hypersensitivity between the 3 groups. Air test: A 1 second blast of air from the air-water syringe was applied to the tooth. Water test: Three drops of ice water were be placed on the tooth. Schiff Score Investigator observed participant reaction to test and scored on following scale: 0-Tooth/Subject does not respond to stimulus.
VAS (visual analog scale): The participant reported sensitivity on a scale of 0-10. 0 being no pain and 10 being worst pain imaginable. | Posted | Median | Inter-Quartile Range | units on a scale | 8 weeks after baseline | Teeth | Teeth |
|
8 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sensodyne | There are no specific characteristics for inclusion in this group. Enrollment will be determined randomly. Sensodyne: Subjects will be instructed to brush with Sensodyne twice daily (2 minutes each time in the morning and the evening) during the duration of the study. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Britta Magnuson | Tufts University School of Dental Medicine | 617-636-3878 | britta.magnuson@tufts.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 4, 2017 | Aug 25, 2020 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Crest Cavity Protection & MI Paste Plus | Device | Subjects will be instructed to brush twice daily (2 minutes each time in the morning and the evening) using Crest Cavity Protection toothpaste. They will be instructed to apply MI Paste Plus (CPP-ACP with fluoride) twice daily to the study teeth after brushing their teeth. MI Paste Plus will be applied to the study teeth with a finger. |
|
| Clinpro 5000 | Device | Subjects will be instructed to brush with Clinpro 5000 twice daily (2 minutes each time in the morning and the evening) during duration of the study. |
|
| Yilmaz HG, Kurtulmus-Yilmaz S, Cengiz E. Long-term effect of diode laser irradiation compared to sodium fluoride varnish in the treatment of dentine hypersensitivity in periodontal maintenance patients: a randomized controlled clinical study. Photomed Laser Surg. 2011 Nov;29(11):721-5. doi: 10.1089/pho.2010.2974. Epub 2011 Jun 13. |
| 18715354 | Background | West NX. Dentine hypersensitivity: preventive and therapeutic approaches to treatment. Periodontol 2000. 2008;48:31-41. doi: 10.1111/j.1600-0757.2008.00262.x. No abstract available. |
| 15755406 | Background | Saunders RH Jr, Meyerowitz C. Dental caries in older adults. Dent Clin North Am. 2005 Apr;49(2):293-308. doi: 10.1016/j.cden.2004.10.004. |
| 9175351 | Background | Hull PS, Worthington HV, Clerehugh V, Tsirba R, Davies RM, Clarkson JE. The reasons for tooth extractions in adults and their validation. J Dent. 1997 May-Jul;25(3-4):233-7. doi: 10.1016/s0300-5712(96)00029-2. |
| 22143734 | Background | Brahmbhatt N, Bhavsar N, Sahayata V, Acharya A, Kshatriya P. A double blind controlled trial comparing three treatment modalities for dentin hypersensitivity. Med Oral Patol Oral Cir Bucal. 2012 May 1;17(3):e483-90. doi: 10.4317/medoral.17594. |
| 20507374 | Background | Orsini G, Procaccini M, Manzoli L, Giuliodori F, Lorenzini A, Putignano A. A double-blind randomized-controlled trial comparing the desensitizing efficacy of a new dentifrice containing carbonate/hydroxyapatite nanocrystals and a sodium fluoride/potassium nitrate dentifrice. J Clin Periodontol. 2010 Jun;37(6):510-7. doi: 10.1111/j.1600-051X.2010.01558.x. |
| 18044379 | Background | Jenson L, Budenz AW, Featherstone JD, Ramos-Gomez FJ, Spolsky VW, Young DA. Clinical protocols for caries management by risk assessment. J Calif Dent Assoc. 2007 Oct;35(10):714-23. |
| 18080486 | Background | Young DA, Featherstone JD, Roth JR, Anderson M, Autio-Gold J, Christensen GJ, Fontana M, Kutsch VK, Peters MC, Simonsen RJ, Wolff MS. Caries management by risk assessment: implementation guidelines. J Calif Dent Assoc. 2007 Nov;35(11):799-805. |
| 1592963 | Background | Featherstone JD, Zero DT. An in situ model for simultaneous assessment of inhibition of demineralization and enhancement of remineralization. J Dent Res. 1992 Apr;71 Spec No:804-10. doi: 10.1177/002203459207100S02. |
| 22699669 | Background | Ito A, Hayashi M, Hamasaki T, Ebisu S. How regular visits and preventive programs affect onset of adult caries. J Dent Res. 2012 Jul;91(7 Suppl):52S-58S. doi: 10.1177/0022034511435701. |
| 23158136 | Background | Wang JX, Yan Y, Wang XJ. Clinical evaluation of remineralization potential of casein phosphopeptide amorphous calcium phosphate nanocomplexes for enamel decalcification in orthodontics. Chin Med J (Engl). 2012 Nov;125(22):4018-21. |
| 21774875 | Background | Su N, Marek CL, Ching V, Grushka M. Caries prevention for patients with dry mouth. J Can Dent Assoc. 2011;77:b85. |
| 17458057 | Background | Kowalczyk A, Botulinski B, Jaworska M, Kierklo A, Pawinska M, Dabrowska E. Evaluation of the product based on Recaldent technology in the treatment of dentin hypersensitivity. Adv Med Sci. 2006;51 Suppl 1:40-2. |
| 9402502 | Background | Holland GR, Narhi MN, Addy M, Gangarosa L, Orchardson R. Guidelines for the design and conduct of clinical trials on dentine hypersensitivity. J Clin Periodontol. 1997 Nov;24(11):808-13. doi: 10.1111/j.1600-051x.1997.tb01194.x. |
| 20669816 | Background | Hughes N, Mason S, Jeffery P, Welton H, Tobin M, O'Shea C, Browne M. A comparative clinical study investigating the efficacy of a test dentifrice containing 8% strontium acetate and 1040 ppm sodium fluoride versus a marketed control dentifrice containing 8% arginine, calcium carbonate, and 1450 ppm sodium monofluorophosphate in reducing dentinal hypersensitivity. J Clin Dent. 2010;21(2):49-55. |
| 16803829 | Background | Ritter AV, de L Dias W, Miguez P, Caplan DJ, Swift EJ Jr. Treating cervical dentin hypersensitivity with fluoride varnish: a randomized clinical study. J Am Dent Assoc. 2006 Jul;137(7):1013-20; quiz 1029. doi: 10.14219/jada.archive.2006.0324. |
| 18165753 | Background | Ostelo RW, Deyo RA, Stratford P, Waddell G, Croft P, Von Korff M, Bouter LM, de Vet HC. Interpreting change scores for pain and functional status in low back pain: towards international consensus regarding minimal important change. Spine (Phila Pa 1976). 2008 Jan 1;33(1):90-4. doi: 10.1097/BRS.0b013e31815e3a10. |
| Crest Cavity Protection & MI Paste Plus |
There are no specific characteristics for inclusion in this group. Enrollment will be determined randomly. Crest Cavity Protection & MI Paste Plus: Subjects will be instructed to brush twice daily (2 minutes each time in the morning and the evening) using Crest Cavity Protection toothpaste. They will be instructed to apply MI Paste Plus (CPP-ACP with fluoride) twice daily to the study teeth after brushing their teeth. MI Paste Plus will be applied to the study teeth with a finger. |
| BG002 | Clinpro 5000 | There are no specific characteristics for inclusion in this group. Enrollment will be determined randomly. Clinpro 5000: Subjects will be instructed to brush with Clinpro 5000 twice daily (2 minutes each time in the morning and the evening) during duration of the study. |
| BG003 | Total | Total of all reporting groups |
| Teeth |
|
| Participants |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years | Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants | Participants |
|
| Baseline Dentinal Hypersensitivity | Air test: 1 sec blast of air from air-water syringe was applied Water test: 3 drops of ice water were applied Schiff Score Investigator observed participant reaction to test and scored 0-Subject does not respond to stimulus
VAS Participant reported sensitivity on scale. 0-no pain, 10-worst pain imaginable | Median | Inter-Quartile Range | units on a scale | Teeth |
|
There are no specific characteristics for inclusion in this group. Enrollment will be determined randomly.
Sensodyne: Subjects will be instructed to brush with Sensodyne twice daily (2 minutes each time in the morning and the evening) during the duration of the study.
| OG001 | Crest Cavity Protection & MI Paste Plus | There are no specific characteristics for inclusion in this group. Enrollment will be determined randomly. Crest Cavity Protection & MI Paste Plus: Subjects will be instructed to brush twice daily (2 minutes each time in the morning and the evening) using Crest Cavity Protection toothpaste. They will be instructed to apply MI Paste Plus (CPP-ACP with fluoride) twice daily to the study teeth after brushing their teeth. MI Paste Plus will be applied to the study teeth with a finger. |
| OG002 | Clinpro 5000 | There are no specific characteristics for inclusion in this group. Enrollment will be determined randomly. Clinpro 5000: Subjects will be instructed to brush with Clinpro 5000 twice daily (2 minutes each time in the morning and the evening) during duration of the study. |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 2 |
| 13 |
| EG001 | Crest Cavity Protection & MI Paste Plus | There are no specific characteristics for inclusion in this group. Enrollment will be determined randomly. Crest Cavity Protection & MI Paste Plus: Subjects will be instructed to brush twice daily (2 minutes each time in the morning and the evening) using Crest Cavity Protection toothpaste. They will be instructed to apply MI Paste Plus (CPP-ACP with fluoride) twice daily to the study teeth after brushing their teeth. MI Paste Plus will be applied to the study teeth with a finger. | 0 | 13 | 0 | 13 | 3 | 13 |
| EG002 | Clinpro 5000 | There are no specific characteristics for inclusion in this group. Enrollment will be determined randomly. Clinpro 5000: Subjects will be instructed to brush with Clinpro 5000 twice daily (2 minutes each time in the morning and the evening) during duration of the study. | 0 | 13 | 0 | 13 | 1 | 13 |
| Infection of foot | Infections and infestations | Systematic Assessment | Subject cut foot and had subsequent infection |
|
| Skin finding | Skin and subcutaneous tissue disorders | Systematic Assessment | Swelling/bump on subject's back |
|
| Fracture of tooth | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Accidental fall | Injury, poisoning and procedural complications | Systematic Assessment | Subject accidentally fell and bruised ribs |
|
| Migraine | Nervous system disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided