[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07704905":3,"trial-entities:NCT07704905":111,"trial-summary:NCT07704905":114},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":10,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":39,"secondary_outcomes":44,"sex":54,"minimum_age":55,"maximum_age":14,"healthy_volunteers":56,"eligibility_criteria":57,"std_ages":83,"locations":86,"central_contacts":101,"overall_officials":106,"references":109,"see_also_links":110},"NCT07704905","400347","A Study to Investigate the Efficacy of an Experimental Dentifrice Containing Stannous Fluoride in Improving Gingival Health","An 8-Week Randomized, Controlled, Examiner-Blind, Clinical Study Investigating the Efficacy of an Experimental Dentifrice Containing Stannous Fluoride in Improving Gingival Health","NOT_YET_RECRUITING","2026-10","2026-07","2026-07-15","HALEON","INDUSTRY",null,"The aim of this study will be to evaluate the ability of using an experimental dentifrice containing 0.454 percent (%) weight for weight (w\u002Fw) Stannous Fluoride (SnF2) to reduce gingivitis and plaque accumulation, compared with a regular fluoride toothpaste (negative control) in participants with mild to moderate gingivitis.","This will be a single-center, 8-week randomized, controlled, single blind (examiner only), 2-treatment arm, parallel group, stratified study, to evaluate the efficacy of using an experimental dentifrice containing 0.454% w\u002Fw Stannous Fluoride, twice daily in reducing gingivitis and plaque accumulation in a population with a clinically measurable level of gingivitis. The clinical efficacy of the experimental dentifrice will be compared to a commercially available regular fluoride dentifrice as negative control. Sufficient participants will be screened to randomize approximately 110 participants (approximately 55 per group) to ensure approximately 100 evaluable participants (approximately 50 per group) complete the study.",[18,19],"Dental Plaque","Gingivitis",[],"INTERVENTIONAL","TREATMENT",[24],"NA",{"count":26,"type":27},110,"ESTIMATED",[29,34],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DRUG","Test Dentifrice","Experimental dentifrice containing 0.454% w\u002Fw SnF2.",[31],{"type":30,"name":35,"description":36,"armGroupLabels":37},"Reference Dentifrice (Colgate Cavity Protection Dentifrice)","A marketed regular fluoride dentifrice.",[38],"Reference Dentifrice",[40],{"measure":41,"description":42,"timeFrame":43},"Change from Baseline in Overall Modified Gingival Index (MGI) at Week 8","The MGI assessment is a non-invasive visual evaluation to assess the symptoms of gingivitis. It will be assessed on all scorable teeth. For each tooth, 3 scores will be recorded and will be scored on a 5-point scale ranging from 0 to 4, where 0 equals (=) Absence of inflammation, 1= Mild inflammation; slight or little change in color; little change in texture of any portion of the marginal\u002F papillary gingival unit, 2= Mild inflammation; criteria as above, but involving the entire marginal\u002F papillary gingival unit, 3= Moderate inflammation; glazing, redness, edema, and\u002F or hypertrophy of the marginal\u002F papillary gingival unit, 4= Severe inflammation; marked redness, edema and\u002F or hypertrophy of the marginal\u002F papillary gingival unit, spontaneous bleeding, congestion, or ulceration. Change from Baseline= Week 8 score minus Baseline score. Lower scores indicate symptom improvement.","Baseline and Week 8",[45,48,51],{"measure":46,"description":47,"timeFrame":43},"Change from Baseline in Interproximal MGI at Week 8","The MGI assessment is a non-invasive visual evaluation to assess the symptoms of gingivitis. It will be assessed on all scorable teeth. For each tooth, 3 scores will be recorded and will be scored on a 5-point scale ranging from 0 to 4, where 0= Absence of inflammation, 1= Mild inflammation; slight or little change in color; little change in texture of any portion of the marginal\u002F papillary gingival unit, 2= Mild inflammation; criteria as above, but involving the entire marginal\u002F papillary gingival unit, 3= Moderate inflammation; glazing, redness, edema, and\u002F or hypertrophy of the marginal\u002F papillary gingival unit, 4= Severe inflammation; marked redness, edema and\u002F or hypertrophy of the marginal\u002F papillary gingival unit, spontaneous bleeding, congestion, or ulceration. Change from Baseline= Week 8 score minus Baseline score. Lower scores will indicate symptom improvement.",{"measure":49,"description":50,"timeFrame":43},"Change from Baseline in Overall Turesky Modification of the Quigley Hein Plaque Index (TPI) at Week 8","TPI will be used to assess plaque on all gradable teeth. The plaque will first be disclosed using a plaque disclosing dye solution. The TPI will be assessed on the facial and lingual surfaces of each scorable tooth. Three scores will be recorded buccally\u002Flabially and three scores lingually\u002Fpalatally. The disclosed plaques will be scored using a 6-point scale ranging from 0 to 5, where 0= No plaque, 1= Separate flecks of plaque at the cervical margin, 2= Thin continuous band of plaque (up to 1 millimeter\\[mm\\]) at the cervical margin, 3= Band of plaque wider than 1 mm but covering less than (\\\u003C) 1\u002F3 of the tooth surface, 4= Plaque covering greater than or equal to (≥) 1\u002F3 but \\\u003C 2\u002F3 of the tooth surface, 5= Plaque covering ≥ 2\u002F3 of the tooth surface. Change from Baseline= Week 8 score minus Baseline score. Lower scores will indicate symptom improvement.",{"measure":52,"description":53,"timeFrame":43},"Change from Baseline in Interproximal TPI at Week 8","TPI will be used to assess plaque on all gradable teeth. The plaque will first be disclosed using a plaque disclosing dye solution. The TPI will be assessed on the facial and lingual surfaces of each scorable tooth. Three scores will be recorded buccally\u002Flabially and three scores lingually\u002Fpalatally. The disclosed plaques will be scored using a 6-point scale ranging from 0 to 5, where 0= No plaque, 1= Separate flecks of plaque at the cervical margin, 2= Thin continuous band of plaque (up to 1 mm) at the cervical margin, 3= Band of plaque wider than 1 mm but covering \\\u003C 1\u002F3 of the tooth surface, 4= Plaque covering ≥ 1\u002F3 but \\\u003C 2\u002F3 of the tooth surface, 5= Plaque covering ≥ 2\u002F3 of the tooth surface. Change from Baseline= Week 8 score minus Baseline score. Lower scores will indicate symptom improvement.","ALL","18 Years",true,{"inclusion":58,"exclusion":62,"raw_text":82},[59,60,61],"Participant provision of a signed and dated informed consent document indicating that the participant will have been informed of all pertinent aspects of the study before any assessment is performed.","A participant who is willing and able to comply with scheduled visits, treatment plan and other study procedures, study restrictions, Lifestyle considerations.","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 participant's ability to understand and follow study procedures and requirements.",[63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81],"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\u002For 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(e.g.), 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 participant who is a pregnant female (self-reported) or intending to become pregnant over the duration of the study.","A female participant who is breastfeeding.","A participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.","A participant unwilling or unable to comply with the lifestyle considerations described in this protocol.","A participant who is a current smoker or an ex-smoker (including vaping) who stopped within 6 months of Screening.","A participant who is using smokeless forms of tobacco (example, chewing tobacco, gutkha, paan containing tobacco, nicotine-based e-cigarettes).","A participant who has diagnosed xerostomia or is taking any medication that in the view of the investigator, is causing xerostomia.","A participant who has a medical condition which could directly influenced gingival bleeding (e.g., type 2 diabetes).","A participant who has a bleeding disorder that could affected study outcomes and\u002For participant safety.","A participant who has a recent history (within the last year) of alcohol or other substance abuse.","A participant who has a severe oral condition (e.g., acute necrotizing ulcerative gingivitis or oral or peri-oral ulceration including herpetic lesions) that could, in the opinion of the investigator, compromise study outcomes or the oral health of the participant\u002Fexaminer if they participate in the study.","Presence of a tongue or lip piercing, or any other oral feature that could interfere with the usage of a toothbrush.","A participant currently taking any such medication or oral care product which in opinion of the investigator could affect gingival condition.","Dental exclusions:","A participant who has previously been enrolled in this study.","A participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study.","Inclusion Criteria:\n\n* Participant provision of a signed and dated informed consent document indicating that the participant will have been informed of all pertinent aspects of the study before any assessment is performed.\n* A participant who is willing and able to comply with scheduled visits, treatment plan and other study procedures, study restrictions, Lifestyle considerations.\n* 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 participant's ability to understand and follow study procedures and requirements.\n\nExclusion Criteria:\n\n* 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.\n* A participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and\u002For during study participation.\n* 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(e.g.), 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.\n* A participant who is a pregnant female (self-reported) or intending to become pregnant over the duration of the study.\n* A female participant who is breastfeeding.\n* A participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.\n* A participant unwilling or unable to comply with the lifestyle considerations described in this protocol.\n* A participant who is a current smoker or an ex-smoker (including vaping) who stopped within 6 months of Screening.\n* A participant who is using smokeless forms of tobacco (example, chewing tobacco, gutkha, paan containing tobacco, nicotine-based e-cigarettes).\n* A participant who has diagnosed xerostomia or is taking any medication that in the view of the investigator, is causing xerostomia.\n* A participant who has a medical condition which could directly influenced gingival bleeding (e.g., type 2 diabetes).\n* A participant who has a bleeding disorder that could affected study outcomes and\u002For participant safety.\n* A participant who has a recent history (within the last year) of alcohol or other substance abuse.\n* A participant who has a severe oral condition (e.g., acute necrotizing ulcerative gingivitis or oral or peri-oral ulceration including herpetic lesions) that could, in the opinion of the investigator, compromise study outcomes or the oral health of the participant\u002Fexaminer if they participate in the study.\n* Presence of a tongue or lip piercing, or any other oral feature that could interfere with the usage of a toothbrush.\n* A participant currently taking any such medication or oral care product which in opinion of the investigator could affect gingival condition.\n* Dental exclusions:\n\n  1. A participant who has active caries that could, in the opinion of the investigator, compromise study outcomes or the oral health of the participant if they participate in the study.\n  2. A participant who has dentures (partial or full).\n  3. A participant who has fixed orthodontic appliances or is undergoing active or recent (within 3 months of Screening) orthodontic treatment, which, in the opinion of the investigator, could interfere with study procedures, assessments or outcomes.\n  4. A participant who has other orthodontic devices (e.g., bands, fixed retainers, or removable retainers) that could, in the opinion of the investigator, interferes with study procedures, assessment, or outcomes.\n  5. A participant who has numerous restorations in a poor state of repair.\n  6. A participant who has any dental condition (e.g., overcrowding) that could, in the opinion of the investigator, compromise study outcomes or the oral health of the participant if they participate in the study.\n  7. A participant who has had dental prophylaxis and teeth bleaching within 12 weeks of Screening.\n  8. A participant who has high levels of extrinsic stain or calculus deposits, in the opinion of the investigator, that could interfered with plaque assessments.\n* A participant who has previously been enrolled in this study.\n* A participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study.",[84,85],"ADULT","OLDER_ADULT",[87],{"facility":88,"city":89,"state":90,"zip":91,"country":92,"contacts":93,"geoPoint":98},"Salus Research Inc","Fort Wayne","Indiana","46825","United States",[94],{"name":95,"role":96,"email":97},"Jeffery L Milleman, DDS","CONTACT","Milleman@Salusresearch.us",{"lat":99,"lon":100},41.1306,-85.12886,[102],{"name":103,"role":96,"phone":104,"email":105},"Haleon Response Center","+441932959500","ww.clinical-trial-register@haleon.com",[107],{"name":95,"affiliation":88,"role":108},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":112,"biomarkers":113},[18,19],[],{"nct_id":4,"found":56,"summary":115,"prompt_version":125},{"design":116,"status":117,"heading":118,"summary":119,"follow_up":120,"word_count":121,"commitments":122,"compensation":123,"drugs_mentioned":124},"This is an 8-week, randomized study comparing two toothpastes, with approximately 110 participants. The examiner will not know which toothpaste each participant is using.","completed","A Study on Stannous Fluoride Dentifrice for Gum Health","This study is looking at how well an experimental toothpaste, called Test Dentifrice (containing 0.454% w\u002Fw Stannous Fluoride), works to improve gum health. It's being compared to a regular fluoride toothpaste (Colgate Cavity Protection Dentifrice). The study aims to see if the experimental toothpaste can reduce gingivitis (gum inflammation) and plaque buildup in people with mild to moderate gingivitis. To join, you need to be at least 18 years old, willing to sign a consent form, and able to follow the study's schedule and procedures. The main goal is to measure the change in gum health after 8 weeks. The current status of this study is unclear.","Your gum health will be measured at the beginning and again at Week 8.",107,"You would use one of the study toothpastes twice daily for 8 weeks and attend scheduled visits.","Not stated in the trial record.",[31],"v2"]