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Completed

NCT Number: NCT01962493

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

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.

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Key information

Conditions

Oral Hygiene

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Intertek 4-Front Research - Widnes, Widnes, Cheshire, United Kingdom

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sodium bicarbonate/ Sodium Fluoride

Other

Toothpaste containing sodium bicarbonate and sodium fluoride as cosmetic

Sodium fluoride

Other

Toothpaste containing sodium fluoride as cosmetic

Chlorhexidine digluconate

Drug

Mouthwash containing chlorhexidine digluconate

Primary outcomes

  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 outcomes

  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).

Interested in participating?

Completed

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Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Study to Evaluate the Effect of a 67% Sodium Bicarbonate Containing Toothpaste on Chlorhexidine Digluconate Tooth Staining

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Oct 14, 2013
Registry last updated
Mar 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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