Last updated: 11/04/2018 12:47:18
Evaluation of plaque fluid fluoride retention from fluoride toothpastes
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Evaluation of plaque fluid fluoride retention from fluoride toothpastes
Trial description: The purpose of this study is to investigate the efficacy of different sodium fluoride (NaF) containing toothpastes in prevention of dental caries. Change from baseline fluoride data at various time points up to four hours after a single brushing with NaF containing toothpastes will be evaluated.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Natural log transformed area under the fluoride concentration in plaque fluid by time curve (AUC) between 0-4 hours
Timeframe: Plaque samples collected at 15 minutes, 30 minutes, 1 hour, 2 hours and 4 hours post single application of treatment
Secondary outcomes:
Natural log transformed AUC for fluoride concentration in plaque fluid between 0-4 hours
Timeframe: Plaque samples collected at 15 minutes, 30 minutes, 1 hour, 2 hours and 4 hours post single application of treatment
Change from baseline in fluoride concentration at 15 minutes after brushing with study treatments
Timeframe: Plaque samples were collected at baseline, 15 minutes post single application of study treatment
Change from baseline in fluoride concentration at 30 minutes post brushing with study treatments
Timeframe: Plaque samples were collected at baseline, 30 minutes post single application of study treatment
Change from baseline in fluoride concentration at 1 hour post brushing with study treatments
Timeframe: Plaque samples were collected at baseline, 1 hour post single application of study treatment
Change from baseline in fluoride concentration at 2 hours post brushing with study treatments
Timeframe: Plaque samples were collected at baseline, 2 hour post single application of study treatment
Change from baseline in fluoride concentration at 4 hours post brushing with study treatments
Timeframe: Plaque samples were collected at baseline, 4 hours post single application of study treatment
Interventions:
Drug: Sodium Fluoride (NaF)
Drug: Placebo
Enrollment:
65
Observational study model:
Not applicable
Primary completion date:
2008-31-10
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
dental caries
Product
Not applicable
Collaborators
Not applicable
Study date(s)
June 2008 to October 2008
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
Yes
- 1. Age:Age 18 through 65 years.
- 2. General Health: Good general health with (in the opinion of the investigator) no clinically significant and/or relevant abnormalities of medical history or oral examination, specifically including diabetes or hypoglycemia.
- 1. Pregnancy:Women who are known to be pregnant or who are intending to become pregnant over the duration of the study. No pregnancy test will be required.
- 2. Breast-feeding:Women who are breast–feeding.
Inclusion and exclusion criteria
Inclusion criteria:
- 1. Age:Age 18 through 65 years. 2. General Health: Good general health with (in the opinion of the investigator) no clinically significant and/or relevant abnormalities of medical history or oral examination, specifically including diabetes or hypoglycemia. 3. Compliance: Understands and is willing, able and likely to comply with all study procedures and restrictions. 4. 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. 5. Oral: a) Currently living in the Indianapolis, Indiana area and not taking fluoride supplements. b) Have a normal stimulated (= 0.8 ml/min) and unstimulated (= 0.2 ml/min) salivary flow rate. c) Have a full complement of natural teeth with the exception of third molars and teeth extracted for orthodontic reasons. Participants natural teeth must have at least one surface free of restoration in each interproximal embrasure. d) Produce at least 6mg of plaque at Screening Visit 2.
Exclusion criteria:
- 1. Pregnancy:Women who are known to be pregnant or who are intending to become pregnant over the duration of the study. No pregnancy test will be required. 2. Breast-feeding:Women who are breast–feeding. 3. Medical History:Current or relevant history of any serious, severe or unstable physical or psychiatric illness that would make the subject unlikely to fully complete the study or any that increases the risk to the subject. 4. Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients. 5. Clinical Study/Experimental Medication:Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit 1 at the start of the study with the exception of those participating in GSKCH study Z3170476. 6. Medication: a) Currently taking antibiotics or have taken antibiotics in the two weeks prior to any treatment visit or during the study. b) Has a medical condition that would require prophylactic antibiotics prior to a dental cleaning. 7. Dental: a) Current active caries or moderate to severe periodontal disease that may compromise the health of the participants or the study. b) Current use of chlorhexidine mouthrinse. 8. Personnel: An employee of the sponsor or the study site who is directly involved in the conduct of the study.
Trial location(s)
Location
Indiana University School of Dentistry
Indianapolis, IN, United States, 46202
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
2008-31-10
Actual study completion date
2008-31-10
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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