Last updated: 11/04/2018 13:49:54
Dose Response of a tubule occlusion agent
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: An exploratory clinical study to evaluate the efficacy of two currently marketed toothpastes containing different concentrations of a tubule occlusion agent
Trial description: To evaluate the efficacy of two different concentrations of a tubule occlusion agent - calcium sodium phosphosilicate in treatment of dentine hypersensitivity
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Adjusted mean change from baseline in evaporative air sensitivity pain response on a Visual Analog Scale (VAS) at Day 15
Timeframe: Baseline to Day 15
Adjusted mean change from baseline in cold water sensitivity pain response on a VAS at Day 15
Timeframe: Baseline to Day 15
Secondary outcomes:
Adjusted mean change from baseline in evaporative air sensitivity pain response on a VAS at Day 7
Timeframe: Baseline to Day 7
Adjusted mean change from baseline in cold water sensitivity pain response on a VAS at Day 7
Timeframe: Baseline to Day 7
Interventions:
Device: 5% calcium sodium phosphosilicate toothpaste
Device: 7.5% calcium sodium phosphosilicate toothpaste
Device: Placebo toothpaste
Enrollment:
195
Observational study model:
Not applicable
Primary completion date:
2009-31-03
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Dentine Hypersensitivity
Product
calcium sodium phosphosilicate
Collaborators
Not applicable
Study date(s)
December 2008 to March 2009
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18 - 50 years
Accepts healthy volunteers
No
- 1. Consent: Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- 2. Age: Aged between 20 – 50 years.
- 1. Pregnancy: Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
- 2. Breast-feeding: Women who are breast–feeding.
Inclusion and exclusion criteria
Inclusion criteria:
- 1. Consent: Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form. 2. Age: Aged between 20 – 50 years. 3. General Health: Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history. 4. Contraception: Females of childbearing potential who are, in the opinion of the investigator, practising a reliable method of contraception. 5. Erosion/Abrasion/Recession:Study teeth must show signs of facial/cervical erosion, abrasion and/or gingival recession. 6. Gingival Health / Tooth Mobility Grade:Study teeth must have Löe and Silness Gingival Index (GI) score less than or equal to 2 and clinical mobility less than or equal to grade I. 7. Current Product Use: Participants must have been using the same brand of toothpaste for at least 2 months and should not have used desensitizing toothpaste during the 4 weeks preceding screening. Participants will be required to bring in their current toothpaste(s) in order to verify the ingredients. 8. VAS Training: Successfully completes the VAS training exercise at Screening. 9. Sensitivity: Self-reported history of dentinal hypersensitivity and a primary complaint of sensitive teeth lasting a maximum of 10 years. At Screening: A minimum of 5 evaporative (air) sensitive lateral incisors, canines or pre-molars must display a response greater than 25 mm on a 100 mm VAS. At Baseline: A minimum of 3 of the 5 evaporative (air) sensitive teeth identified at screening must display a response greater than 25 mm on a 100 mm VAS. All teeth meeting the sensitivity Inclusion Criteria will be followed and assessed using both efficacy parameters. 10. Compliance: Understands and is willing, able and likely to comply with all study procedures and restrictions.
Exclusion criteria:
- 1. Pregnancy: Women who are known to be pregnant or who are intending to become pregnant over the duration of the study. 2. Breast-feeding: Women who are breast–feeding. 3. Medical History: a) Chronic debilitating disease is present b)Chronic disease or other condition is present that is associated with intermittent episodes or constant daily pain, such as arthritis, low back pain, dysmenorrhea, etc. 4. Medications: Daily doses of medication, which in the opinion of the investigator, might interfere with the perception of pain, are being taken. Examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilizers, mood-altering and anti-inflammatory drugs. 5. Dentition Exclusions: a) Sensitive teeth not expected to respond to treatment with an over-the- counter (OTC) dentifrice in the opinion of the investigator. b) Teeth with exposed dentine but with deep, defective or facial restorations, teeth used as abutments for fixed or removable partial dentures, teeth with full crowns, orthodontic bands, extensive caries or cracked enamel. Sensitive teeth with contributing aetiologies other than erosion, abrasion or recession of exposed dentine. c) Dental professional hygiene (includes dental prophylaxis, irrigation, and intensive anti-microbial/anti-biotic therapy) within 14 days of the screening visit. d) Presence of dental implants. e) Lip or tongue piercings. f) Periodontal surgical history within the past 6 months or have been scaled /root planed within the past 3 months. 6. Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients. 7. Clinical Study/Experimental Medication: a) Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.b) Previous participation in this study. 8. Xerostomia: Any condition or medication that causes xerostomia. 9. Personnel: An employee of the sponsor or the study site or members of their immediate family. 10. Other: Any subject who in the opinion of the investigator, should not participate in the study.
Trial location(s)
Location
University Park Research Center (UPRC)
Fort Wayne, IN, United States, 46825
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2009-31-03
Actual study completion date
2009-31-03
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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