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Trial record 45 of 292 for:    Sodium Fluoride OR Duraphat

An Efficacy Study of Stain Control of a 67% Sodium Bicarbonate Containing Toothpaste on Chlorhexidine Tooth Staining

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ClinicalTrials.gov Identifier: NCT01962493
Recruitment Status : Completed
First Posted : October 14, 2013
Results First Posted : November 3, 2014
Last Update Posted : March 3, 2015
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
The aim of this study is to compare the stain effect on teeth of twice daily brushing with a 67% sodium bicarbonate containing toothpaste versus standard toothpaste (not containing sodium bicarbonate) for six weeks whilst using a chlorhexidine digluconate 0.2% mouthwash.

Condition or disease Intervention/treatment Phase
Oral Hygiene Other: Sodium bicarbonate/ Sodium Fluoride Other: Sodium fluoride Drug: Chlorhexidine digluconate Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: A Study to Evaluate the Effect of a 67% Sodium Bicarbonate Containing Toothpaste on Chlorhexidine Digluconate Tooth Staining
Study Start Date : September 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013


Arm Intervention/treatment
Sodium bicarbonate/ Sodium Fluoride toothpaste
Marketed Sodium bicarbonate toothpaste containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)
Other: Sodium bicarbonate/ Sodium Fluoride
Toothpaste containing sodium bicarbonate and sodium fluoride as cosmetic

Active Comparator: Sodium fluoride toothpaste
Non-sodium bicarbonate toothpaste containing 1450ppm fluoride as NaF
Other: Sodium fluoride
Toothpaste containing sodium fluoride as cosmetic

Chlorhexidine digluconate mouthwash
0.2% w/v Chlorhexidine digluconate mouthwash for rinsing post-brushing with study toothpastes
Drug: Chlorhexidine digluconate
Mouthwash containing chlorhexidine digluconate




Primary Outcome Measures :
  1. Modified Lobene Stain Index (MLSI) at Week 6 [ Time Frame: Week 6 post treatment administration ]
    An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 6 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).


Secondary Outcome Measures :
  1. Overall MLSI at Week 3 [ Time Frame: Week 3 post treatment administration ]
    An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 3 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).

  2. Overall Facial MLSI at Week 3 [ Time Frame: Week 3 post treatment administration ]
    An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 3 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).

  3. Overall Facial MLSI at Week 6 [ Time Frame: Week 6 post treatment administration ]
    An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 6 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).

  4. Overall Interproximal MLSI at Week 3 [ Time Frame: Week 3 post treatment administration ]
    An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 3 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).

  5. Overall Interproximal MLSI at Week 6 [ Time Frame: Week 6 post treatment administration ]
    An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 6 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).

  6. Overall Gingival and Interproximal MLSI at Week 3 [ Time Frame: Week 3 post treatment administration ]
    An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 3 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).

  7. Overall Gingival and Interproximal MLSI at Week 6 [ Time Frame: Week 6 post treatment administration ]
    An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 6 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Good oral health in the opinion of the investigator (excluding gingivitis)
  • A minimum of 11 of the 12 permanent gradable anterior teeth at screening
  • Stain levels on the buccal surfaces of the 6 maxillary and 6 mandibular anterior teeth need to be at least "mild" and present on a minimum of 4 teeth
  • Modification of the Lobene Stain Index - At Visit 2, a baseline total MLSI Intensity x Area score (four sites per tooth) of greater than or equal to 8 for facial surfaces of anterior teeth.

Exclusion Criteria:

  • Pregnant women or women who are intending to become pregnant over the duration of the study
  • Known or suspected intolerance or hypersensitivity to Chlorhexidine or other study materials (or closely related compounds).
  • Current use of Chlorhexidine, Cetylpyridinium Chloride or any marketed mouthwash
  • Past or current use of any drug which is known to be associated with tooth discolouration within 30 days of screening or during the study period.
  • Recent history (within the last 1 year) of alcohol or other substance abuse
  • Dental conditions / disease requiring immediate treatment; Crowns or veneers on more than one anterior tooth; pre-existing sensitivity to oral care products; severe periodontitis; severe recession; dental implants; active carious lesions on anterior teeth; oral lesions/manifestations; prone to aphthous stomatitis and ulceration etc.
  • Participant with untreated oral mucosal disease which in the opinion of the investigator could interfere with the study.
  • Medical condition which would require the use of prophylactic antibiotics prior to dental cleanings
  • Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any medical disorder that would make the participant unlikely to fully complete the study or any condition that presents undue risk from the study treatment or procedures in the opinion of the investigator or dental assessor.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01962493


Locations
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United Kingdom
Intertek 4-Front Research - Widnes
Widnes, Cheshire, United Kingdom, WA8 6PG
Intertek - Maldon (formerly 4 Front Research Ltd)
Maldon, Essex, United Kingdom, CM9 5PN
Intertek - Manchester Science Park
Manchester, United Kingdom, M15 6SE
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01962493     History of Changes
Other Study ID Numbers: 202182
RH01913 ( Other Identifier: GSK )
First Posted: October 14, 2013    Key Record Dates
Results First Posted: November 3, 2014
Last Update Posted: March 3, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Listerine
Fluorides
Sodium Fluoride
Tooth Discoloration
Tooth Diseases
Stomatognathic Diseases
Chlorhexidine
Chlorhexidine gluconate
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents