NCT01962493

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2013

Shorter than P25 for phase_4

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 10, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 14, 2013

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
1 year until next milestone

Results Posted

Study results publicly available

November 3, 2014

Completed
Last Updated

March 3, 2015

Status Verified

February 1, 2015

Enrollment Period

2 months

First QC Date

October 10, 2013

Results QC Date

July 17, 2014

Last Update Submit

February 12, 2015

Conditions

Oral Hygiene

Outcome Measures

Primary Outcomes (1)

  • Modified Lobene Stain Index (MLSI) at Week 6

    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).

    Week 6 post treatment administration

Secondary Outcomes (7)

  • Overall MLSI at Week 3

    Week 3 post treatment administration

  • Overall Facial MLSI at Week 3

    Week 3 post treatment administration

  • Overall Facial MLSI at Week 6

    Week 6 post treatment administration

  • Overall Interproximal MLSI at Week 3

    Week 3 post treatment administration

  • Overall Interproximal MLSI at Week 6

    Week 6 post treatment administration

  • +2 more secondary outcomes

Study Arms (3)

Sodium bicarbonate/ Sodium Fluoride toothpaste

OTHER

Marketed Sodium bicarbonate toothpaste containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)

Other: Sodium bicarbonate/ Sodium Fluoride

Sodium fluoride toothpaste

ACTIVE COMPARATOR

Non-sodium bicarbonate toothpaste containing 1450ppm fluoride as NaF

Other: Sodium fluoride

Chlorhexidine digluconate mouthwash

OTHER

0.2% w/v Chlorhexidine digluconate mouthwash for rinsing post-brushing with study toothpastes

Drug: Chlorhexidine digluconate

Interventions

Sodium bicarbonate/ Sodium FluorideOTHER

Toothpaste containing sodium bicarbonate and sodium fluoride as cosmetic

Sodium bicarbonate/ Sodium Fluoride toothpaste
Sodium fluorideOTHER

Toothpaste containing sodium fluoride as cosmetic

Sodium fluoride toothpaste
Chlorhexidine digluconateDRUG

Mouthwash containing chlorhexidine digluconate

Chlorhexidine digluconate mouthwash

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Intertek 4-Front Research - Widnes

Widnes, Cheshire, WA8 6PG, United Kingdom

Location

Intertek - Maldon (formerly 4 Front Research Ltd)

Maldon, Essex, CM9 5PN, United Kingdom

Location

Intertek - Manchester Science Park

Manchester, M15 6SE, United Kingdom

Location

Related Publications (1)

  • Akwagyiram I, Butler A, Maclure R, Colgan P, Yan N, Bosma ML. A randomised clinical trial to evaluate the effect of a 67 % sodium bicarbonate-containing dentifrice on 0.2 % chlorhexidine digluconate mouthwash tooth staining. BMC Oral Health. 2016 Aug 25;16(1):79. doi: 10.1186/s12903-016-0271-3.

    PMID: 27557865DERIVED

MeSH Terms

Interventions

Sodium BicarbonateSodium Fluoridechlorhexidine gluconate

Intervention Hierarchy (Ancestors)

BicarbonatesCarbonatesCarbonic AcidCarbon Compounds, InorganicInorganic ChemicalsSodium CompoundsFluoridesHydrofluoric AcidFluorine CompoundsCariostatic AgentsBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Results Point of Contact

Title
GSK Response Center
Organization
GlaxoSmithKline
866-435-7343

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2013

First Posted

October 14, 2013

Study Start

September 1, 2013

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

March 3, 2015

Results First Posted

November 3, 2014

Record last verified: 2015-02

Locations

GB(3)