A Proof-of-principle Clinical Study Investigating the Efficacy of an Experimental Dentifrice Cont… (NCT04737538) | Clinical Trial Compass
CompletedPhase 2
A Proof-of-principle Clinical Study Investigating the Efficacy of an Experimental Dentifrice Containing Sodium Bicarbonate and Sodium Hyaluronate on Gingivitis
Canada110 participantsStarted 2021-02-10
Plain-language summary
The aim of this study is to develop a daily use toothpaste containing sodium bicarbonate, sodium hyaluronate and sodium fluoride with the intention of providing improved/ fast gum healing. This Proof-of-Principle study will investigate the efficacy of an experimental dentifrice compared to a regular fluoride dentifrice, and also whether this provides any additional benefit in reducing gingival inflammation/ bleeding compared with a 67% w/w sodium bicarbonate/ 0.221% w/w sodium fluoride containing toothpaste.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participant with at least 20 natural, permanent teeth.
. Participant with at least 40 evaluable surfaces for MGI, BI and TPI. An evaluable surface is defined as having 2/3rds of the natural tooth surface gradable for the selected clinical indices. The following should not be included in the evaluable surface count- third molars; fully crowned/extensively restored, grossly carious, orthodontically banded/bonded or abutment teeth; surfaces with calculus deposits which, in the opinion of the clinical examiner, would interfere with the baseline assessments of the selected clinical indices.
. Participant with generalized mild- moderate plaque-induced gingivitis, in the opinion of the clinical examiner, as confirmed by a gross visual examination at the Screening Visit.
. Participant with ongoing hard tissue eligibility and, in the opinion of the clinical examiner, at least 40 evaluable surfaces.
. Participant with mean whole mouth MGI between 1.75 and 2.30.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Bleeding Sites at 6 Weeks (Comparison of Experimental Versus Negative Control Dentifrice)
. Participant with mean whole mouth TPI score ≥1.5.
. Participant with a minimum of 20 bleeding sites.
Exclusion criteria
. Dental Product/Treatment and Oral Hygiene Restrictions From Screening (Visit 1) to the Participant's Last Study Visit • Participants should not use any other oral care products (e.g. dentifrices, toothbrushes, mouthrinses) other than those provided during the study.
. Dietary and Smoking Restrictions From Screening (Visit 1) to the Participant's Last Study Visit • Participants should not chew gum or consume any confectionery containing xylitol (e.g. mints).
. Participant currently taking antibiotics or requiring antibiotic use prior to dental prophylaxis or other dental procedures.
. Participant currently taking an anti-inflammatory medication which, in the opinion of the Investigator, could affect gingival condition.
. Participant currently taking a systemic medication (e.g. anti-inflammatory, anti-coagulant, immunosuppressants) or traditional/ herbal remedy which, in the opinion of the Investigator, could affect plaque/ gingival condition (e.g. ibuprofen, aspirin, warfarin, cyclosporin, phenytoin, calcium channel blockers).
. Participant who has taken (in the previous 14 days), any antibiotics.
. Participant who has taken (in the previous 14 days) a systemic medication (e.g. antiinflammatory, anti-coagulant, immunosuppressants) or traditional/ herbal remedy which, in the opinion of the Investigator, could affect plaque/ gingival condition (e.g. ibuprofen, aspirin, warfarin, cyclosporin, phenytoin, calcium channel blockers).
. Participant who has used an antibacterial dentifrice or mouthwash (e.g. chlorhexidine) or any oral care product that in the view of the investigator could interfere with plaque formation or measures of gingivitis, in the period between Screening and the Baseline