A Six Month Clinical Study Based in the US to Evaluate the Efficacy and Tolerability of Sodium Bicarbonate Toothpaste

Oral Hygiene Clinical Trial

Official title:

A Six Month Clinical Study Based in the US to Evaluate the Efficacy and Tolerability of Sodium Bicarbonate Toothpaste

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02207907
• Other study ID #: 202192
• Secondary ID: RH02433
• Status: Completed
• Phase: N/A
• First received: July 31, 2014
• Last updated: April 9, 2015
• Start date: August 2014
• Est. completion date: February 2015

Study information

• Verified date: April 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The primary objectives of this study will be to compare the Gingival Bleeding and Gingival Inflammation following twice daily use of a sodium bicarbonate experimental dentifrice compared to a 0% sodium bicarbonate toothpaste after 24 weeks of use. The study will be conducted at Silverstone Research Group. Participants will be recruited from their database and by use of an external recruitment agency.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 247
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or oral/dental examination.

• A minimum of 20 permanent gradable teeth

• Moderate gingivitis present at the screening visit in the opinion of the investigator

• A total of 20 bleeding sites or greater at baseline visit

• Positive response to bleeding on brushing present at the screening visit

Exclusion Criteria:

• Pregnant or breast feeding women

• Tobacco chewers

• Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any other medical condition (e.g. Diabetes Mellitus) that would make the participant unlikely to fully complete the study or any that increases the risk to the participants or undermines the data validity.

• Recent history (within the last year) of alcohol or other substance abuse

• Participants requiring prophylactic antibiotic treatment prior to dental therapy

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

• Have current active caries or any medical conditions which may directly influence gingival bleeding

• Use of concomitant or any systemic medication that, in the opinion of the investigator, might interfere with the outcome of the study or have an effect on gingival conditions within 14 days of gingival examinations

• Excessive calculus present that interferes with the probing examination for Gingival Bleeding Index

• Participation in another clinical study or receipt of an investigational drug or oral care product within 30 days of the screening visit

• An employee of the sponsor or the study site or members or their immediate family.

Study Design

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

Related Conditions & MeSH terms

• Oral Hygiene

Intervention

Drug:
• Sodium bicarbonate plus sodium fluoride
Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
• Sodium fluoride
Toothpaste containing 1100 ppm fluoride as sodium fluoride

Locations

Country	Name	City	State
United States	GSK Investigational Site	Las Vegas	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation and comparison of Gingival Bleeding (as assessed by number of bleeding sites) following twice daily use of a sodium bicarbonate experimental dentifrice compared to a 0% sodium bicarbonate toothpaste after 24 weeks	The Bleeding Index will be performed by a single examiner using a color coded periodontal probe. The probe will be engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure will be used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system to be used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed	24 weeks	No
Primary	Evaluation and comparison of gingivitis (as assessed by the Modified Gingival Index, (MGI) following twice daily use of a sodium bicarbonate experimental dentifrice compared to a 0% sodium bicarbonate toothpaste after 24 weeks.	The Modified Gingival Index (MGI) will be assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin). The scoring of the MGI will be performed under dental office conditions using a standard dental light for illuminating the oral cavity. Compressed air, water and mouth mirrors will be available to each examiner. This procedure will be performed by a single examiner. The MGI scoring system is as follows: 0 = absence of inflammation; 1 = mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit; 2 = mild inflammation; criteria as above but involving the entire marginal or papillar gingival units; 3= moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal or papillary gingival unit; 4 = severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration	24 weeks	No
Secondary	Evaluation and comparison of Gingival Bleeding (as assessed by number of bleeding sites) following twice daily use of a sodium bicarbonate experimental dentifrice compared to a 0% sodium bicarbonate toothpaste after 6 and 12 weeks.	The Bleeding Index will be performed by a single examiner using a color coded periodontal probe. The probe will be engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure will be used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system to be used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed	12 weeks	No
Secondary	Evaluation and comparison of gingivitis (as assessed by the Modified Gingival Index, (MGI)) following twice daily use of a sodium bicarbonate experimental dentifrice compared to a 0% sodium bicarbonate toothpaste after 6 and 12 weeks.	The Modified Gingival Index (MGI) will be assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin). The scoring of the MGI will be performed under dental office conditions using a standard dental light for illuminating the oral cavity. Compressed air, water and mouth mirrors will be available to each examiner. This procedure will be performed by a single examiner. The MGI scoring system is as follows: 0 = absence of inflammation; 1 = mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit; 2 = mild inflammation; criteria as above but involving the entire marginal or papillar gingival units; 3= moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal or papillary gingival unit; 4 = severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration	12 weeks	No
Secondary	Evaluation and comparison of Bleeding Index following twice daily use of a toothpaste containing sodium bicarbonate experimental dentifrice compared to a toothpaste without sodium bicarbonate (0%) after 6, 12 and 24 weeks	The Bleeding Index will be performed by a single examiner using a color coded periodontal probe. The probe will be engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure will be used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system to be used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed	24 weeks	No
Secondary	Evaluation and comparison of plaque control (overall and interproximal dental plaque scores) using Turesky modification of Quigley & Hein plaque index following twice daily use of two toothpastes after 6, 12 weeks and 24 weeks.	The dental examiner will use the Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth. The plaque will first be disclosed using a dye solution. Participants will then rinse with disclosing solution according to instructions. They will expectorate and rinse with 10 mL of water for 10 seconds and expectorate again. Plaque will be assessed with each tooth being divided into 6 areas including the mesiofacial, facial, distofacial, mesiolingual, lingual and distolingual surfaces. Disclosed plaque will be scored as follows: 0= No plaque; 1= Slight flecks of plaque at the cervical margin of the tooth; 2= A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth; 3= A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth; 4= Plaque covering at least 1/3 but less tan 2/3 of the crown of the tooth; 5= Plaque covering 2/3 or more of the crown of the tooth	24 weeks	No