Evaluation of a Test Mouthwash and Dentifrice Regimen in an In-situ Model of Dental Erosion

Tooth Erosion Clinical Trial

Official title:

Evaluation of a Test Mouthwash and Dentifrice Regimen in an In-situ Model of Dental Erosion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01128972
• Other study ID #: Z3480664
• Status: Completed
• Phase: Phase 2
• First received: April 30, 2010
• Last updated: December 11, 2014
• Start date: August 2009
• Est. completion date: October 2009

Study information

• Verified date: December 2014
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

An in situ model will be used to evaluate and compare enamel remineralization of bovine enamel specimens.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• An intact maxillary dental arch suitable for the retention of the palatal appliance and an intact mandibular dental arch - subjects may have fixed bridges replacing missing teeth

• No current active caries or periodontal disease that may compromise the study or the health of the subjects

• A gum base stimulated whole saliva flow rate greater than or equal to 0.8 mL/minute and an unstimulated whole saliva flow rate greater than or equal to 0.2 mL/minute

Exclusion Criteria:

• Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tooth Erosion

Intervention

Drug:
• Sodium fluoride
Test fluoride toothpaste and test fluoride mouth rinse
• Sodium monoflurophosphate
United Kingdom marketed fluoride toothpaste
• Sterile water
Sterile water rinse

Locations

Country	Name	City	State
United States	Indiana University School of Dentistry	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (1)

Maggio B, Guibert RG, Mason SC, Karwal R, Rees GD, Kelly S, Zero DT. Evaluation of mouthrinse and dentifrice regimens in an in situ erosion remineralisation model. J Dent. 2010 Nov;38 Suppl 3:S37-44. doi: 10.1016/S0300-5712(11)70007-0. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adjusted Mean Percent NER of Enamel Specimens Exposed to a Treatment Regimen of Placebo Dentifrice + Test MR Relative to: 1) Test Dentifrice +Test MR 2) Test Dentifrice + Sterile Water Rinse 3) Reference Dentifrice +Sterile Water Rinse	Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine NER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent NER was calculated by formula: [(E1-E2)/ (E1-B)]*100. Smaller the negative NER, better is treatment regimen in imparting resistance to enamel.	Baseline, 4 hours post treatment in each treatment period	No
Other	Adjusted Mean Percentage SMH Recovery of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to Following Treatment Regimens: 1) Test Dentifrice +Test MR 2) Test Dentifrice + Sterile Water 3) Reference Dentifrice +Sterile Water	SMH test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1-R)/ (E1-B)]*100.	Baseline, 4 hours post treatment in each treatment period	No
Other	Adjusted Mean Percent NER of Enamel Specimens Exposed to Test Dentifrice +Sterile Water Rinse and Reference Dentifrice +Sterile Water Rinse	Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine NER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent NER was calculated by formula: [(E1-E2)/ (E1-B)]*100. Smaller the negative NER, better is treatment regimen in imparting resistance to enamel.	Baseline, 4 hours post treatment in each treatment period	No
Other	Adjusted Mean Percent SMH Recovery of Enamel Specimens Exposed to Test Dentifrice +Sterile Water Rinse and Reference Dentifrice +Sterile Water Rinse	SMH test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1-R)/ (E1-B)]*100.	Baseline, 4 hours post treatment in each treatment period	No
Primary	Adjusted Mean Percent Net Erosion Resistance (NER) of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to: 1) Test Dentifrice+ Sterile Water Rinse 2) Reference Dentifrice+ Sterile Water Rinse 3) Placebo Dentifrice+ Sterile Water Rinse	Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine NER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent NER was calculated by formula: [(E1-E2)/ (E1-B)]*100. Smaller the negative NER, better is treatment regimen in imparting resistance to enamel.	Baseline, 4 hours post treatment in each treatment period	No
Secondary	Adjusted Mean Percentage Surface Microhardness (SMH) Recovery of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to: 1)Test Dentifrice+Sterile Water Rinse 2)Reference Dentifrice+Sterile Water Rinse 3)Placebo Dentifrice+ Sterile Water Rinse	SMH test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1-R)/ (E1-B)]*100.	Baseline, 4 hours post treatment in each treatment period.	No