A Clinical Study Investigating the Effect of an Experimental Toothpaste Containing Stannous Fluoride in Improving Gingival Health

Not Applicable

Completed

• Conditions: Dental Plaque; Gingivitis
• Interventions: Drug: Test toothpaste; Drug: Colgate Cavity Protection Toothpaste

• Registration Number: NCT06602466
• Lead Sponsor: HALEON

Brief Summary

The aim of this 4-week clinical study is to evaluate the ability of an experimental toothpaste, containing 0.454 percent (%) Stannous Fluoride (SnF2), 0.3% Zinc Chloride (ZnCl2) and 1% Alumina, to improve gingival health and plaque accumulation compared to a regular fluoride toothpaste (negative control) in participants with plaque-induced mild to moderate gingivitis.

Detailed Description

This will be a single-center, 4 weeks, randomized, controlled, examiner-blind, 2 treatment arms, stratified, parallel group design clinical study, investigating gingival health and supra-gingival plaque reduction on healthy participants after using an experimental toothpaste containing 0.454% SnF2, 0.3% ZnCl2 and 1% Alumina. Sufficient participants will be screened so that at least 160 participants are randomized (approximately 80 per group) to ensure approximately 144 (approximately 72 per group) evaluable participants complete the entire study.

Study Timeline

• Study First Submitted: 2024-09-17
• Study First Submitted QC: 2024-09-17
• Study First Posted: 2024-09-19
• Study Start: 2024-09-23
• Status Verified: 2024-12
• Primary Completion: 2024-12-13
• Study Completion: 2024-12-13
• Last Update Submitted: 2024-12-24
• Last Update Posted: 2024-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

Inclusion Criteria

• 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.
• Biological sex at birth was male or female.
• Aged 18 to 70 years inclusive, at the signing of the informed consent.
• Willing and able to comply with scheduled visits, treatment plan, saliva sample collection, study restrictions, Lifestyle Considerations and other study procedures.
• 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.
• Participant oral health that meets all the following:

At Screening (Visit 1):

• Participant with at least 20 natural, permanent teeth, (excluding 3rd molars).
• Participant with at least 40 evaluable surfaces for MGI, BI, and TPI.
• A healthy participant with mild to moderate plaque-induced gingivitis in the opinion of the clinical examiner.
• Overall MGI less than or equal to (<=) 1.75 to <= 2.30

At Baseline (Visit 2):

• Overall MGI greater than or equal to (>=) 1.75 to <= 2.30
• Overall TPI score >= 1.5

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Exclusion Criteria

• 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 or psychiatric condition or laboratory abnormality 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 has any other clinical serious or unstable conditions (for example, cardiovascular diseases, diabetes, liver disorders, and kidney disorders) which could have affected study outcomes and/or participant safety.

• A participant who is pregnant (self-reported) or intending to become pregnant over the duration of the study.

• A participant who is breastfeeding.

• A participant with known or suspected intolerance or hypersensitivity to any 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 vaper) who stopped within 6 months of Screening.

• A participant who is using smokeless forms of tobacco (for example, chewing tobacco, gutkha, pan containing tobacco, nicotine-based e-cigarettes).

• A participant who is 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 have directly influenced gingival bleeding.

• A participant who has a bleeding disorder that could have affected study outcomes and/or 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 (for example, 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/examiner 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.

• Medications exclusions: At Screening (Visit 1):

  1. A participant using any antibiotic medication within 28 days prior to screening or at any time during the study.
  2. Participant who has used an anti-bacterial toothpaste/mouthwash (for example, chlorhexidine) or another oral care product within 2 weeks of Screening that, in the opinion of the investigator or dentally qualified designee, could affect gingival health, plaque formation or oral bacteria.
  3. A participant currently taking an anti-inflammatory medication which, in the opinion of the Investigator, could affect gingival condition.
  4. A participant currently taking a systemic medication (for example, anti-inflammatory, anticoagulant, immunosuppressants) or traditional/ herbal remedy which, in the opinion of the Investigator, could affect plaque/ gingival condition (for example, ibuprofen, aspirin, warfarin, cyclosporin, phenytoin, calcium channel blockers, statins).

• Medications exclusions: At Baseline (Visit 2):

  1. A participant who has taken any antibiotics during the washout period (between Screening and Baseline).
  2. A participant who has taken (in the previous 14 days) a systemic medication (for example, anti-inflammatory, anti-coagulant, immunosuppressants) or traditional/ herbal remedy which, in the opinion of the Investigator, could affect plaque/ gingival condition (for example, ibuprofen, aspirin, warfarin, cyclosporin, phenytoin, calcium channel blockers).
  3. A participant who has used an antibacterial dentifrice or mouthwash (for example, chlorhexidine) or any oral care product that in the view of the investigator could interfere with gingival health, plaque formation and oral bacteria, in the period between Screening and the Baseline visit.

• Periodontal exclusions:

  1. A participant who shows signs of periodontitis [at both Screening (Visit 1) and Baseline visits (Visit 2)].
  2. A participant with a Basic Periodontal Examination (BPE) score of 4 or above in one or more sextants.
  3. A participant with BPE score >= 3, if with probing pocket, a single tooth dept is >= 5 mm.
  4. A participant who is receiving or has received treatment for periodontal disease (including surgery) within 12 months of Screening.
  5. A participant who has gingivitis, which in the opinion of the investigator, is not expected to respond to treatment with an over the counter (OTC) dentifrice.

• Dental Exclusions:

  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.
  2. A participant who has dentures (partial or full).
  3. A participant who has an orthodontic appliance (bands, appliances, or fixed/ removable retainers).
  4. A participant who received orthodontic therapy within 3 months of Screening.
  5. A participant who has numerous restorations in a poor state of repair.
  6. A participant who has any dental condition (for example, 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.
  7. A participant who has had dental prophylaxis within 12 weeks of Screening.
  8. A participant who has had teeth bleaching within 12 weeks of Screening.
  9. A participant who has high levels of extrinsic stain or calculus deposits, in the opinion of the investigator, that could have interfered with plaque assessments.

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test Toothpaste	Test toothpaste	Participants will brush their teeth with full ribbon of test toothpaste on head of toothbrush for one timed minute twice a day (morning and evening) for 4 weeks.
Reference Toothpaste (Negative Control)	Colgate Cavity Protection Toothpaste	Participants will brush their teeth with full ribbon of reference toothpaste (Colgate Cavity Protection) on head of toothbrush for one timed minute twice a day (morning and evening) for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Mean Bleeding Index (BI) at Week 4	Week 4	The BI is an invasive assessment of gingival bleeding. To perform the bleeding assessment, a round-end probe is inserted approximately 1 millimeter (mm) into the gingival sulcus (at approximately 60 degrees) and moved around the tooth from the distal interproximal area to the mesial interproximal area, gently stretching the gingival epithelium. Presence/absence of gingival bleeding is assessed for 30 seconds after probing. BI will be assessed for all evaluable surfaces (having two-thirds of the natural tooth surface gradable for the assessment) of the facial and lingual/palatal gingiva, six sites per tooth and scored on 3-points scale 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.

Secondary Outcome Measures

Name	Time	Method
Mean Number of Bleeding Sites (NBS) at Week 4	Week 4	The bleeding assessment will be done using round-end probe. The probe will be inserted approximately 1 mm into the gingival sulcus (at approximately 60 degrees) and moved around the tooth from the distal interproximal area to the mesial interproximal area, gently stretching the gingival epithelium. Bleeding will be assessed for all evaluable surfaces (having two-thirds of the natural tooth surface gradable for the assessment) of the facial and lingual/palatal gingiva, six sites per tooth. The number of bleeding sites for each participant= the number of evaluable tooth sites with bleeding observed immediately on probing or within 30 seconds of probing.
Mean Modified Gingival Index (MGI) at Week 4	Week 4	The MGI is a non-invasive visual assessment of gingival inflammation. MGI will be assessed for all evaluable surfaces of the facial and lingual/palatal gingiva, four sites per tooth and will be scored on a 5-point scale ranging from 0 to 4, where 0= Absence of inflammation, 1= Mild inflammation; slight change in colour, little change in colour; little change in texture of any portion of the marginal or papillary gingival unit. 2= Mild inflammation; criteria as (1) but involving the entire marginal or papillar gingival unit. 3= Moderate inflammation; glazing, redness, oedema, and/or hypertrophy of the marginal or papillary gingival unit. 4= Severe inflammation; marked redness, oedema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. Lower score indicates improvement in the symptoms.
Mean Overall Turesky Plaque Index (TPI) at Week 4	Week 4	The TPI is a non-invasive assessment of supra-gingival plaque accumulation. TPI will be assessed for all evaluable surfaces of the facial and lingual surfaces of the teeth. Each tooth surface is divided into 3 areas; three scores are recorded facially (mesiofacial, facial, distofacial) and three scores lingually (mesiolingual, lingual and distolingual), generating six scores per tooth and the mean value will be calculated. The plaque will be disclosed using a plaque disclosing dye solution and the TPI will be assessed using a 6-point scale ranging from 0 to 5, where 0= No plaque, 1= Slight flecks of plaque at the cervical margin of the tooth, 2= Thin, continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth, 3= Band of plaque wider than 1 mm but covering less than (\<)1/3 of the area, 4= Plaque covering at least 1/3 but \< 2/3 of the area, 5= Plaque covering 2/3 or more of the crown of the tooth. Lower score indicates improvement in the symptoms.
Mean Interproximal TPI at Week 4	Week 4	The TPI is a non-invasive assessment of supra-gingival plaque accumulation. TPI will be assessed for all evaluable surfaces of the facial and lingual surfaces of the teeth (7-7 in each arch). Each tooth surface is divided into 3 areas; three scores are recorded facially (mesiofacial, facial, distofacial) and three scores lingually (mesiolingual, lingual and distolingual), generating six scores per tooth and the mean value will be calculated. The plaque will be disclosed using a plaque disclosing dye solution and the TPI will be assessed using a 6-point scale ranging from 0 to 5, where 0= No plaque, 1= Slight flecks of plaque at the cervical margin of the tooth, 2= Thin, continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth, 3= Band of plaque wider than 1 mm but covering \< 1/3 of the area, 4= Plaque covering at least 1/3 but \< 2/3 of the area, 5= Plaque covering 2/3 or more of the crown of the tooth. Lower score indicates improvement in the symptoms.

Trial Locations

Locations (1)

Birmingham University Dental School; 🇬🇧 Birmingham, United Kingdom