A Clinical Study to Evaluate the Effectiveness of an Experimental Toothpaste in Improving Gum Health and Reducing Plaque Accumulation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHALEON
About this trial
The aim of this 24-week clinical study is to evaluate the ability of an experimental dentifrice containing 0.454 percent (%) weight by weight (w/w) Stannous fluoride (SnF2); to improve gingival health, plaque reduction and prevention of plaque accumulation compared with a regular fluoride dentifrice (negative control) in participants with mild to moderate gingivitis.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
Participant is of either sex and any gender who, at the time of screening, is at least 18 years old, inclusive.
A participant who is willing and able to comply with scheduled visits, treatment plan and other study procedures.
A participant in good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in medical history or upon oral examination, or condition, that would impact the participant 's safety, wellbeing or the outcome of the study, if they were to participate in the study, or affect the individual's ability to understand and follow study procedures and requirements.
Disqualifiers
A participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or a Haleon employee directly involved in the conduct of the study or a member of their immediate family.
A participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation.
A participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical, psychiatric condition or laboratory abnormality or any other clinical serious or unstable conditions (example, cardiovascular diseases, diabetes, liver disorders, and kidney disorders) that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study.
A female participant who is a pregnant (self-reported) or intending to become pregnant over the duration of the study or who is breastfeeding.
Trial design
Design model
Parallel
Treatments tested in this trial
Test Dentifrice
DrugExperimental dentifrice containing 0.454% w/w SnF2.
Parodontax Complete Protection
DrugMarketed dentifrice containing 0.454% w/w SnF2.
Colgate Cavity Protection
DrugMarketed regular fluoride dentifrice.
Treatment groups
300 Participants
are divided into 3 treatment groupsGroup A: Test DentifriceExperimental treatment 1 intervention
Group B: Reference Dentifrice (Positive Control)Active comparator 1 intervention
Group C: Reference Dentifrice (Negative Control)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of Bleeding Sites (Overall) at Week 24
Number of bleeding sites will be assessed using the bleeding index (BI) assessment. BI will be assessed for all evaluable surfaces of the facial and lingual/palatal gingiva, six sites per tooth. The probe will be inserted approximately 1 millimeter (mm) into the gingival sulcus and moved around the tooth from the distal interproximal area to the mesial interproximal area, gently stretching the gingival epithelium. The number of bleeding sites for each participant will be calculated as the number of tooth sites with bleeding observed immediately on probing or within 30 seconds of probing.
Time frame
Week 24Secondary outcomes
1
Number of Bleeding Sites (Overall) at Weeks 1, 4 and 12
Number of bleeding sites will be assessed using the BI assessment. BI will be assessed for all evaluable surfaces of the facial and lingual/palatal gingiva, six sites per tooth. The probe will be inserted approximately 1 mm into the gingival sulcus and moved around the tooth from the distal interproximal area to the mesial interproximal area, gently stretching the gingival epithelium. The number of bleeding sites for each participant will be calculated as the number of tooth sites with bleeding observed immediately on probing or within 30 seconds of probing.
Time frame
Weeks 1, 4 and 122
Number of Bleeding Sites (Interproximal) at Weeks 1, 4 and 12
Number of bleeding sites will be assessed using the BI assessment. BI will be assessed for all evaluable surfaces of the facial and lingual/palatal gingiva, six sites per tooth. The probe will be inserted approximately 1 mm into the gingival sulcus and moved around the tooth from the distal interproximal area to the mesial interproximal area, gently stretching the gingival epithelium. The number of bleeding sites for each participant will be calculated as the number of tooth sites with bleeding observed immediately on probing or within 30 seconds of probing.
Time frame
Weeks 1, 4 and 123
Number of Bleeding Sites (Interproximal) at Week 24
Number of bleeding sites will be assessed using the BI assessment. BI will be assessed for all evaluable surfaces of the facial and lingual/palatal gingiva, six sites per tooth. The probe will be inserted approximately 1 mm into the gingival sulcus and moved around the tooth from the distal interproximal area to the mesial interproximal area, gently stretching the gingival epithelium. The number of bleeding sites for each participant will be calculated as the number of tooth sites with bleeding observed immediately on probing or within 30 seconds of probing.
Time frame
Week 244
Mean BI (Overall) at Weeks 1, 4, 12 and 24
The BI is an invasive assessment of gingival bleeding. BI will be assessed for all evaluable surfaces of the facial and lingual/palatal gingiva, six sites per tooth. The probe will be inserted approximately 1 mm into the gingival sulcus and moved around the tooth from the distal interproximal area to the mesial interproximal area, gently stretching the gingival epithelium. Gingival bleeding will be scored on a 3-points scale with scores ranging from 0 to 2, where 0=Absence of bleeding on probing, 1=Bleeding observed within 30 seconds of probing, 2=Bleeding observed immediately on probing. Mean BI will be calculated by taking the average over all tooth sites assessed for a participant. Lower score indicates improvement in the symptoms.
Time frame
Weeks 1, 4, 12 and 24 Source ClinicalTrials.gov